Changes in the Intestinal Microbiota Under Hypobaric Hypoxia ConditionsEarly Phase 1NCT07624409
Program Protocol for a Population That Works in Conditions of Hypobaric Hypoxia
A Early Phase 1 study testing Probiotic Nutritional Intervention, Overload Exercise Protocol and Bioimpedanciometry in people with Changes in the Intestinal Microbiota Under Hypobaric Hypoxia Conditions and Changes in Blood Glucose Under Hypobaric Hypoxia Conditions, run by Jorge Torres Mejías at 1 site in Chile.
Trial summary
The objective of this randomized, longitudinal, single-blind, two-group parallel clinical trial is to evaluate the effect of a physical exercise and nutritional protocol on the health determinants of workers performing their work shift under hypobaric hypoxia conditions at 2,950 meters above sea level (masl) and to… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Changes in the Intestinal Microbiota Under Hypobaric Hypoxia Conditions, Changes in Blood Glucose Under Hypobaric Hypoxia Conditions, Changes in Body Composition Under Hypobaric Hypoxia Conditions
- What is being tested?
- Probiotic Nutritional Intervention, Overload Exercise Protocol and Bioimpedanciometry
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 1 Jul 2026to 30 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be an employee of the ALMA Observatory, Chile.
- Reside in the AOS (5,000 m above sea level) or OSF (2,950 m above sea level) sectors.
- Have more than one year of employment history.
Who cannot join
- Individuals with pacemakers.
- Individuals only temporarily residing in observatory areas located in the Antofagasta Region.
- Pregnant women.
- Individuals with metal implants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Physical and Nutritional Exercise Program Protocol for the Improvement of the Health Determinants of a Population That Works in Conditions of Intermittent Hypobaric Hypoxia
The objective of this randomized, longitudinal, single-blind, two-group parallel clinical trial is to evaluate the effect of a physical exercise and nutritional protocol on the health determinants of workers performing their work shift under hypobaric hypoxia conditions at 2,950 meters above sea level (masl) and to determine whether these interventions contribute to improving their health.
For this study, initial assessments of body composition, physical fitness tests, gut microbiota analysis, blood inflammatory markers, and quality of life surveys will be conducted on all subjects during the first and last day of their work shift at 2,950 masl. Subsequently, they will be divided into two groups. Subjects in Group 1 (G1) will follow the same guided exercise protocol along with a nutritional plan designed by the research team. Those in Group 2 (G2) will undergo guided physical training for the seven days they are working under hypobaric hypoxia conditions. Finally, the results of the analyses between time 1 and time 2 will be compared, in addition to intra-group evaluations
Read the detailed description
This study is an investigation that seeks to evaluate the effect of a physical exercise and nutritional protocol on the determinants of health (nutritional status and body composition, metabolic-inflammatory parameters, glucose profile, gut microbiome, physical condition, autonomic nervous system, and sleep patterns) of workers who perform their workday at an astronomical observatory under hypobaric hypoxia conditions between 2,950 and 5,050 meters above sea level. The objective of this intervention is to standardize both physical and nutritional recommendations for this type of worker under intermittent hypobaric hypoxia conditions.
The procedure will begin by incorporating personnel who meet the inclusion criteria: (being an employee contracted by the ALMA Observatory with more than one year of seniority, working in AOS or OSF sectors of the observatory, and not suffering from non-communicable diseases such as type 2 diabetes or hypertension). On the other hand, the exclusion criteria for this research are: people who use pacemakers, those who are temporarily stationed at the facilities, and pregnant women. Once the "n" of 11 subjects for each research group has been obtained, all participants will undergo a nutritional and body composition assessment by a registered dietitian. This assessment will utilize a multifrequency bioimpedance analysis (BIA) device, model INBODY 270S. Participants will be asked to come to the designated laboratory after fasting for 4 hours and removing as much clothing as possible, including shoes, socks, and any metal jewelry. The analysis will consist of weighing the participant in kilograms and measuring their height (SECA 700 scale). Subsequently, waist and hip circumferences will be measured using a SECA 201 ergonomic measuring tape. To complete the nutritional assessment, participants will be asked to step onto the BIA device barefoot, where they will place the hand electrodes and follow the evaluation instructions provided by the device. Subsequently, a Polar H10 elastic heart rate monitor will be fitted to the chest area and connected to the Polar Beat app for continuous heart rate monitoring. Along with this heart rate monitor, each participant will also have an Actigraph WG3XBT elastic heart rate monitor fitted to their hip area to measure the intensity of their movements. To determine the physical condition and estimate the VO2max of the subjects under study, all will undergo a Modified Queens College box test, in a 20 cm high box for a period of 3 minutes. Finally, a Freestyle Libre 2 Plus continuous glucose monitoring patch will be fitted to the left triceps. These individually fitted devices will continue to collect data for 14 consecutive days. Once the entire installation phase is complete, each participant will be given two sealed, sterilized plastic containers. In these containers, they must provide the research team with two small fecal samples (one on the day of arrival at the observatory and another on the last day of their stay). These samples will be processed in the laboratory set up for this purpose at the observatory using a QIAamp PowerFecal Pro DNA Kit. A DNA sample will be extracted following the kit's instructions, then frozen and transported to the University facilities. There, the samples will be processed using a DNA sequencing system. They will be stored in the buffer included with the aforementioned extraction kit and subsequently frozen in a special -20°C refrigerator at the GEMA laboratory for later analysis. The samples will then be analyzed using an Invitrogen Qubit fluorometer to quantify the concentration of extracted DNA. Subsequently, the samples will be analyzed using capillary electrophoresis on a Bioptic Fragment Analyzer™ (QSep 1). Following this, the libraries will be prepared according to the sequencer to be used, and sequencing will then begin on an Illumina MiSeq and/or Nanopore MinION platform (depending on the number of DNA samples extracted and the amount of data to be sequenced).
In addition, a trained paramedic will collect 5 ml of venous blood, which will be placed in polypropylene tubes with anticoagulant and centrifuged at 3000 rpm. The plasma and blood will then be sent refrigerated to the CEIMA laboratory at Arturo Prat University for analysis and quantification of inflammatory factors using the SOD Colorimeter Activity Kit and the GSH-PX Activity Kit, following the respective manufacturers' instructions.
Once the initial analyses are complete, the study subjects will be divided into two groups:
G1 (Intervention group with resistance training and nutritional supplementation) This group will undergo a resistance training program guided by a physical activity professional for three days during their work shift, along with a daily intake of a probiotic and prebiotic supplement for seven days. To this end, the maximum number of repetitions (1RM) that the individual can perform for each of the four muscle groups will be calculated at the beginning. Therefore, 3 sets of 10 repetitions each will be performed for the following muscle groups: 1. biceps, 2. quadriceps, 3. pectorals, and 4. gastrocnemius, at 50% of the previously calculated maximum repetition.
In addition, this group's diet will be supplemented with the administration of two "Karún Life" brand probiotic tablets for the seven days of the work shift.
G2 (Overload Physical Exercise Intervention Group) This group will undergo the same overload training program as the previous group under the same conditions mentioned above.
- Conditions
- Changes in the Intestinal Microbiota Under Hypobaric Hypoxia Conditions, Changes in Blood Glucose Under Hypobaric Hypoxia Conditions, Changes in Body Composition Under Hypobaric Hypoxia Conditions, Determination of Physiological Stress in Hypobaric Hypoxia
- Being tested
- Probiotic Nutritional Intervention, Overload Exercise Protocol, Bioimpedanciometry, heart rate, continuous glucose analysis
- Keywords
- microbiota in hypobaric hypoxia, body composition in hypobaric Hypoxia, Physical condition under hypobaric hypoxia conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Nutritional InterventionDietary supplement
Also called Gut Microbiota Under Hypobaric Hypoxia
The entire group will be supplemented with a known dose of 2 tablets daily of the probiotic "Karún Life" for 2 weeks (during the work week and the subsequent week of rest).
Overload Exercise ProtocolOther
Also called physical exercise, overload exercise, exercises under hypobaric hypoxia conditions
On the first day of sampling, muscle strength will be evaluated using arm and back dynamometry. Along with this, "the maximum repetition" (1RM) of the pectoral, quadriceps, biceps and gastrocnemius muscle groups will be determined, with their values recorded on the record. Subsequently, an exercise protocol will be carried out during day 2-4-6 of the work day, using eccentric muscle contraction exercises, with 50% of the maximum weight achieved in the initial tests, in the same muscle groups previously evaluated, through 3 series with 10 repetitions each. ending the intervention with a new dynamometry evaluation of the arms, back and MRI in these muscle groups.
BioimpedanciometryDevice
Also called Body Composition, fat mass, free fat mass, Bioimpedanciómetry
Determination of body composition and phase angle in both intervention groups (G1 and G2), during day one of the beginning of the work shift and the last day, both under conditions of intermittent hypobaric hypoxia. For which, the subjects will be placed with as little clothing as possible, without any metal on the body, with bare feet on the InBody Bioimpedancemeter, Model: 270S., with which fat mass, fat-free mass, total body water, intracellular water, extracellular water and phase angle will be calculated.
heart rateDevice
A heart rate monitor belt, POLAR brand, model H10, will be installed on all subjects in both groups, for 14 continuous days (seven days in conditions of hypobaric hypoxia and 7 days in normobaric conditions), equipment that will remain connected to the accelerometer that the participants will have, in order to record their heart rate along with the intensity of movement.
continuous glucose analysisDevice
Also called glicemias continua, monitor de glicemia continua
On the first day after the start of the work shift, a FreeStyle brand continuous glucose measurement patch will be installed in the area of the right triceps, which will be removed on the 14th (after the return of a new work shift), with which it is expected to know the glucose curves of people who perform work under conditions of intermittent hypobaric hypoxia between 2950 meters above sea level and 5050 meters above sea level.
gut microbiota analysisBiological
Also called Gut microbioma
A small sample of feces will be requested from each individual on day 1 at the start of the work shift and on day 7 at the end of the shift. Bacterial DNA will be extracted from these samples according to the manufacturer's protocol (QIAGEN_QIAamp PowerFecal Pro DNA Kit), which will be frozen to be sent to the GEMA laboratory of the Catholic University of Maule, where they will be sequenced in a Bioptic Fragment Analyzer processor (QSep 1).
AccelerometerDevice
Also called Accelerometry, energy expenditure, moviment intensity
On the first day of the start of the work shift, an elastic belt with an Actigraph brand accelerometer, model wgt3x-bt, will be installed, which will be attached to the body on the right hip of each subject under study. This device will be removed on the 14th day of use, with which it is expected to quantify the intensity of the subject's movement, both during their work days and days of rest (between 2950 meters above sea level and 5050 meters above sea level).
Evaluation of sleep quality, using the Pittsburgh surveyOther
Also called Cuestionario Pittsburg
A private survey will be carried out with each of the subjects being evaluated, using a survey to determine the quality of sleep of each person in conditions of intermittent hypobaric hypoxia called the Pittsburg Scale, an activity that will be carried out on a single occasion, during the work shift.
Quality of life survey SF36 v2.Other
Also called Quality of life
Like the other surveys, we will use the SF32 V2 survey to develop the level of quality of life of each evaluated subject. This survey will be carried out privately, with an ONLINE questionnaire only once during the work shift.
Cardiac Variability DeterminationProcedure or surgery
Also called Variabilidad Cardiaca
During the first day of stay in conditions of hypobaric hypoxia, taking advantage of the H10 heart rate monitor installed in each subject together with the KUBIOS HRV application and an OMROM blood pressure meter, the evaluation of cardiac variability will be carried out, an activity that will be carried out in the clinic adapted for this work, for which, a time outside of work will be organized, during a rest time, (due to the protocol of the test). This evaluation is secondary to the study
VO2 max estimateProcedure or surgery
During the initial physical evaluations, you will undergo a physical test called the modified Queens Box, (in a 20 cm high box with a test duration of 3 minutes), in which the person must step up to the box and down from it in pulses of 96 per minute for men and 88 for women. The pulses obtained by the subject evaluated using the installed Polar H10 heart rate monitor will be recorded on a record at the end of the test, at minute 1, 2 and 3 once the test is finished.
Encuesta alimentariaOther
Also called consumer trend survey, 24-hour recall survey
During a day different from the initial evaluations, two personal surveys related to diet will be carried out on each study subject, which will be carried out by a qualified nutritionist professional. These surveys will provide valuable information on the eating habits of the study subjects during their working hours under conditions of hypobaric hypoxia and during their rest days.
| Study group | Role | What they receive |
|---|---|---|
| Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia | Active comparator | All members of group G1 of "overload exercise intervention", an activity that will be carried out 3 times during the week, will have three data collection devices installed, which are: heart rate monitor belt on the chest, accelerometer on the right hip, and continuous glucose analyzer on the right triceps, which will carry out continuous data collection for 14 consecutive days. Along with this, this entire group will also undergo a battery of exams: body composition analysis, phase angle determination, fecal DNA extraction, venous blood sample and a Queens College physical box test, which will be carried out on day one, (at the beginning of the work shift) and later on day seven, (last day of the shift). Along with this, food surveys on consumption trends and 24-hour counts will be carried out. Similarly, a Pittsburgh survey and the SF36 V2 survey will be applied to the entire population. Receives: Other: Overload Exercise Protocol; Device: Bioimpedanciometry; Device: heart rate; Device: continuous glucose analysis; Biological: gut microbiota analysis; Device: Accelerometer; Other: Evaluation of sleep quality, using the Pittsburgh survey; Other: Quality of life survey SF36 v2.; Procedure: Cardiac Variability Determination; Procedure: VO2 max estimate; Other: Encuesta alimentaria |
| Group undergoing resistance training plus probiotic intake. | Experimental | Arm Description: Group G2 of "overload exercise intervention and probiotic intake" will receive a dose of two daily tablets of Karún Life probiotics. Along with this, three data collection devices will be installed: a heart rate monitor belt on the chest, an accelerometer on the right hip, and a continuous glucose analyzer on the right triceps, which will carry out continuous data collection for 14 consecutive days. Along with this, this entire group will also undergo a battery of tests: body composition analysis, phase angle determination, fecal DNA extraction, venous blood sample and a Queens College physical box test, which will be carried out on day one, (at the beginning of the work shift) and later on day seven, (last day of the shift). Along with this, food surveys on consumption trends and 24-hour counts will be carried out. Similarly, a Pittsburgh survey and the SF36 V2 survey will be applied to the entire population. Receives: Dietary Supplement: Probiotic Nutritional Intervention; Other: Overload Exercise Protocol; Device: Bioimpedanciometry; Device: heart rate; Device: continuous glucose analysis; Biological: gut microbiota analysis; Device: Accelerometer; Other: Evaluation of sleep quality, using the Pittsburgh survey; Other: Quality of life survey SF36 v2.; Procedure: Cardiac Variability Determination; Procedure: VO2 max estimate; Other: Encuesta alimentaria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Fitness, (ml/kg/min oxygen utilization)
A modified Queens College box test (20 centimeter box height for 3 minutes) will be performed. Men will perform the test at 90 pulses per minute, while women will perform the test at a speed of 88 pulses per minute, for 3 minutes. Once the time is up, the participant's final pulse will be recorded using the POLAR H10 heart rate monitor, to later determine the aerobic capacity of each subject in ml/kg/min.
Measured: day 1 and 7 of the work shift
Glucose Curve (mg/dl)
To determine the constant metabolic status of circulating glucose of the study subjects, a continuous glucose analyzer will be installed in each of them in the triceps area of the right arm, using the Abbott FreeStyle Libre analysis monitor. For which the triceps area will be cleaned with cotton and 75% alcohol to later install the measurement patch, which must remain for 14 continuous days, so it will be removed on day 14 (when each person returns to a new work shift). With this analysis, it is expected to know the behavior of plasma glucose in mg/dl.
Measured: from the beginning of the work shift up to 14 consecutive days
Body Composition (%fat mass, %free fat mass, %total body water)
Determination of body composition by percentage of fat mass, percentage of fat-free mass, percentage of total body water, (extracellular water, intracellular water and phase angle). To do this, the patient will be asked to remove all metal elements from the body along with as much clothing as possible. To carry out this entire evaluation, the InBody brand bioimpedance meter, model 270S, will be used.
Measured: day 1 and 7 of the work shift
Food surveys
Two dietary surveys will be carried out, the first is called "Evaluation of food consumption trends", while the second is a "24-hour intake count", with which macronutrients can be determined in grams.
Measured: day 2 of the work shift
Evaluation of movement intensity (METS/hora)
The quantification of the movement of each of the subjects under study will be carried out through the use of an Actigraph accelerometer, model wgt3x-bt. Equipment that will be installed using an elastic belt on the right hip of each of the study subjects, which will determine the intensity of the movement, due to the intensity peaks that can be demonstrated in counts per minute, this information will give us the METs/hour of each of the study subjects.
Measured: from day 1 of the work shift to day 14
Heart Rate Quantification
A POLAR heart rate monitor, model H10, will be used to maintain constant monitoring of each of the study subjects. This equipment will be installed on the chest of each individual, which must be in direct contact with the skin using an elastic belt, below the sternum, indicating pulses/minute.
Measured: from day 1 of the work shift to day 14
Muscle Strength (1RM)
Upper body strength evaluations will be carried out, through the use of hand dynamometers and another to determine back strength. Along with this, a calculation of one repetition maximum (1RM) will be carried out for the muscle groups: Pectorals, Quadriceps, biceps and hamstrings. Once these values are recorded, the study subjects from both groups will undergo an overload exercise program, in the same muscle groups mentioned above, using a format of 3 sets for 10 repetitions in each muscle group at 50% of 1RM, for 3 days of the work week, every 48 hours.
Measured: Day 1 of the work shift and day 7 of the shift
Secondary outcomes (1)
Cardiac Variability
After taking initial exams and evaluations, an appointment will be coordinated with each of the study subjects during the first day of stay in conditions of hypobaric hypoxia at 2950 meters above sea level. At this time, the subject will be asked to lie on a stretcher, without moving and without speaking for 10 minutes, during which blood pressure will be measured every 2 minutes in the left arm, using an OMROM analyzer. Along with this, your heart rate will constantly be read using the Polar H10 heart rate monitor previously installed on your chest. heart rate that will be recorded by the KUBIOS HRV application, which will determine the heart variability of each of the subjects.
Measured: Day 1 of the work shift and day 7 of the shift
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Changes in the Intestinal Microbiota Under Hypobaric Hypoxia ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study of two independent groups of people in parallel with different types of interventions, who are in hypobaric hypoxia conditions at the same time.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jorge Torres Mejías
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorge Torres Mejías, Centro de Investigación Andina para la Altitud Geografica
- Investigators
- jorge H Torres Mejías, Magister, Principal investigator, Centro de Investigación Andino para la Altitud Geográfica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624409
- Sponsor's protocol ID
- CIAAG09/2026UCM
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing the data of the patients with whom this research will be carried out will depend on whether the participant himself accepts, through informed consent, to share his studied background with the scientific community.
Publications
Torres-Mejias J, Arriaza K, Mena F, Rivarola E, Paredes P, Ahmad H, Lopez I, Soza D, Pino-Villalon JL, Lopez-Espinoza MA, Duran-Aguero S, Merellano-Navarro E. Body Composition, Microbiome and Physical Activity in Workers Under Intermittent Hypobaric Hypoxia. Nutrients. 2025 Dec 15;17(24):3919. doi: 10.3390/nu17243919.
PubMed 41470864Su Q, Zhuang DH, Li YC, Chen Y, Wang XY, Ge MX, Xue TY, Zhang QY, Liu XY, Yin FQ, Han YM, Gao ZL, Zhao L, Li YX, Lv MJ, Yang LQ, Xia TR, Luo YJ, Zhang Z, Kong QP. Gut microbiota contributes to high-altitude hypoxia acclimatization of human populations. Genome Biol. 2024 Aug 28;25(1):232. doi: 10.1186/s13059-024-03373-w.
PubMed 39198826Shanahan F, Ghosh TS, O'Toole PW. The Healthy Microbiome-What Is the Definition of a Healthy Gut Microbiome? Gastroenterology. 2021 Jan;160(2):483-494. doi: 10.1053/j.gastro.2020.09.057. Epub 2020 Nov 27.
PubMed 33253682Nishimura T, Motoi M, Toyoshima H, Kishida F, Shin S, Katsumura T, Nakayama K, Oota H, Higuchi S, Watanuki S, Maeda T. Endocrine, inflammatory and immune responses and individual differences in acute hypobaric hypoxia in lowlanders. Sci Rep. 2023 Aug 4;13(1):12659. doi: 10.1038/s41598-023-39894-w.
PubMed 37542110Nathan NN, Philpott DJ, Girardin SE. The intestinal microbiota: from health to disease, and back. Microbes Infect. 2021 Jul-Aug;23(6-7):104849. doi: 10.1016/j.micinf.2021.104849. Epub 2021 Jun 17.
PubMed 34146716Mallet RT, Burtscher J, Pialoux V, Pasha Q, Ahmad Y, Millet GP, Burtscher M. Molecular Mechanisms of High-Altitude Acclimatization. Int J Mol Sci. 2023 Jan 15;24(2):1698. doi: 10.3390/ijms24021698.
PubMed 36675214Liu D, Chen D, Xiao J, Wang W, Zhang LJ, Peng H, Han C, Yao H. High-altitude-induced alterations in intestinal microbiota. Front Microbiol. 2024 May 9;15:1369627. doi: 10.3389/fmicb.2024.1369627. eCollection 2024.
PubMed 38784803Li L, Zhou Y, Zou S, Wang Y. The Effects of High-Altitude Mountaineering on Cognitive Function in Mountaineers: A Meta-Analysis. Int J Environ Res Public Health. 2023 Mar 14;20(6):5101. doi: 10.3390/ijerph20065101.
PubMed 36982007Lang M, Bilo G, Caravita S, Parati G. [Blood pressure and high altitude: physiological response and clinical management]. Medwave. 2021 May 13;21(4):e8194. doi: 10.5867/medwave.2021.04.8194. Spanish.
PubMed 34037579Karl JP, Cole RE, Berryman CE, Finlayson G, Radcliffe PN, Kominsky MT, Murphy NE, Carbone JW, Rood JC, Young AJ, Pasiakos SM. Appetite Suppression and Altered Food Preferences Coincide with Changes in Appetite-Mediating Hormones During Energy Deficit at High Altitude, But Are Not Affected by Protein Intake. High Alt Med Biol. 2018 Jun;19(2):156-169. doi: 10.1089/ham.2017.0155. Epub 2018 Feb 12.
PubMed 29431471Hill NE, Deighton K, Matu J, Misra S, Oliver NS, Newman C, Mellor A, O'Hara J, Woods D. Continuous Glucose Monitoring at High Altitude-Effects on Glucose Homeostasis. Med Sci Sports Exerc. 2018 Aug;50(8):1679-1686. doi: 10.1249/MSS.0000000000001624.
PubMed 29613998Gotteland M, Zazueta A, Pino JL, Fresard A, Sambra V, Codoceo J, Cires MJ, Lopez X, Vivanco JP, Magne F. Modulation of Postprandial Plasma Concentrations of Digestive Hormones and Gut Microbiota by Foods Containing Oat ss-Glucans in Healthy Volunteers. Foods. 2023 Feb 6;12(4):700. doi: 10.3390/foods12040700.
PubMed 36832775Gatterer H, Roche J, Turner R, Vinetti G, Roveri G, Schlittler M, Kob M, Walzl A, Dal Cappello T, Debevec T, Siebenmann C. Changes in body mass, appetite-related hormones, and appetite sensation in women during 4 days of hypobaric hypoxic exposure equivalent to 3,500-m altitude. J Appl Physiol (1985). 2023 Jan 1;134(1):133-141. doi: 10.1152/japplphysiol.00369.2022. Epub 2022 Dec 8.
PubMed 36476162El Alam S, Pena E, Aguilera D, Siques P, Brito J. Inflammation in Pulmonary Hypertension and Edema Induced by Hypobaric Hypoxia Exposure. Int J Mol Sci. 2022 Oct 21;23(20):12656. doi: 10.3390/ijms232012656.
PubMed 36293512Debenham MIB, Smuin JN, Grantham TDA, Ainslie PN, Dalton BH. Hypoxia and standing balance. Eur J Appl Physiol. 2021 Apr;121(4):993-1008. doi: 10.1007/s00421-020-04581-5. Epub 2021 Jan 23.
PubMed 33484334
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Nutritional Exercise Program Protocol for the Improvement of the Health Determinants of a Population That Works in Conditions of Intermittent Hypobaric Hypoxia
- ClinicalTrials.gov ID
- NCT07624409
- Acronym / sponsor ID
- CIAAG09/2026UCM
- Conditions
- Changes in the Intestinal Microbiota Under Hypobaric Hypoxia Conditions, Changes in Blood Glucose Under Hypobaric Hypoxia Conditions, Changes in Body Composition Under Hypobaric Hypoxia Conditions, Determination of Physiological Stress in Hypobaric Hypoxia
- Keywords
- microbiota in hypobaric hypoxia, body composition in hypobaric Hypoxia, Physical condition under hypobaric hypoxia conditions
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Jorge Torres MejíasUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized, longitudinal, single-blind, two-group parallel clinical trial is to evaluate the effect of a physical exercise and nutritional protocol on the health determinants of workers performing their work shift under hypobaric hypoxia conditions at 2,950 meters above sea level (masl) and to determine whether these interventions contribute to improving their health.
For this study, initial assessments of body composition, physical fitness tests, gut microbiota analysis, blood inflammatory markers, and quality of life surveys will be conducted on all subjects during the first and last day of their work shift at 2,950 masl. Subsequently, they will be divided into two groups. Subjects in Group 1 (G1) will follow the same guided exercise protocol along with a nutritional plan designed by the research team. Those in Group 2 (G2) will undergo guided physical training for the seven days they are working under hypobaric hypoxia conditions. Finally, the results of the analyses between time 1 and time 2 will be compared, in addition to intra-group evaluations
Detailed description
This study is an investigation that seeks to evaluate the effect of a physical exercise and nutritional protocol on the determinants of health (nutritional status and body composition, metabolic-inflammatory parameters, glucose profile, gut microbiome, physical condition, autonomic nervous system, and sleep patterns) of workers who perform their workday at an astronomical observatory under hypobaric hypoxia conditions between 2,950 and 5,050 meters above sea level. The objective of this intervention is to standardize both physical and nutritional recommendations for this type of worker under intermittent hypobaric hypoxia conditions.
The procedure will begin by incorporating personnel who meet the inclusion criteria: (being an employee contracted by the ALMA Observatory with more than one year of seniority, working in AOS or OSF sectors of the observatory, and not suffering from non-communicable diseases such as type 2 diabetes or hypertension). On the other hand, the exclusion criteria for this research are: people who use pacemakers, those who are temporarily stationed at the facilities, and pregnant women. Once the "n" of 11 subjects for each research group has been obtained, all participants will undergo a nutritional and body composition assessment by a registered dietitian. This assessment will utilize a multifrequency bioimpedance analysis (BIA) device, model INBODY 270S. Participants will be asked to come to the designated laboratory after fasting for 4 hours and removing as much clothing as possible, including shoes, socks, and any metal jewelry. The analysis will consist of weighing the participant in kilograms and measuring their height (SECA 700 scale). Subsequently, waist and hip circumferences will be measured using a SECA 201 ergonomic measuring tape. To complete the nutritional assessment, participants will be asked to step onto the BIA device barefoot, where they will place the hand electrodes and follow the evaluation instructions provided by the device. Subsequently, a Polar H10 elastic heart rate monitor will be fitted to the chest area and connected to the Polar Beat app for continuous heart rate monitoring. Along with this heart rate monitor, each participant will also have an Actigraph WG3XBT elastic heart rate monitor fitted to their hip area to measure the intensity of their movements. To determine the physical condition and estimate the VO2max of the subjects under study, all will undergo a Modified Queens College box test, in a 20 cm high box for a period of 3 minutes. Finally, a Freestyle Libre 2 Plus continuous glucose monitoring patch will be fitted to the left triceps. These individually fitted devices will continue to collect data for 14 consecutive days. Once the entire installation phase is complete, each participant will be given two sealed, sterilized plastic containers. In these containers, they must provide the research team with two small fecal samples (one on the day of arrival at the observatory and another on the last day of their stay). These samples will be processed in the laboratory set up for this purpose at the observatory using a QIAamp PowerFecal Pro DNA Kit. A DNA sample will be extracted following the kit's instructions, then frozen and transported to the University facilities. There, the samples will be processed using a DNA sequencing system. They will be stored in the buffer included with the aforementioned extraction kit and subsequently frozen in a special -20°C refrigerator at the GEMA laboratory for later analysis. The samples will then be analyzed using an Invitrogen Qubit fluorometer to quantify the concentration of extracted DNA. Subsequently, the samples will be analyzed using capillary electrophoresis on a Bioptic Fragment Analyzer™ (QSep 1). Following this, the libraries will be prepared according to the sequencer to be used, and sequencing will then begin on an Illumina MiSeq and/or Nanopore MinION platform (depending on the number of DNA samples extracted and the amount of data to be sequenced).
In addition, a trained paramedic will collect 5 ml of venous blood, which will be placed in polypropylene tubes with anticoagulant and centrifuged at 3000 rpm. The plasma and blood will then be sent refrigerated to the CEIMA laboratory at Arturo Prat University for analysis and quantification of inflammatory factors using the SOD Colorimeter Activity Kit and the GSH-PX Activity Kit, following the respective manufacturers' instructions.
Once the initial analyses are complete, the study subjects will be divided into two groups:
G1 (Intervention group with resistance training and nutritional supplementation) This group will undergo a resistance training program guided by a physical activity professional for three days during their work shift, along with a daily intake of a probiotic and prebiotic supplement for seven days. To this end, the maximum number of repetitions (1RM) that the individual can perform for each of the four muscle groups will be calculated at the beginning. Therefore, 3 sets of 10 repetitions each will be performed for the following muscle groups: 1. biceps, 2. quadriceps, 3. pectorals, and 4. gastrocnemius, at 50% of the previously calculated maximum repetition.
In addition, this group's diet will be supplemented with the administration of two "Karún Life" brand probiotic tablets for the seven days of the work shift.
G2 (Overload Physical Exercise Intervention Group) This group will undergo the same overload training program as the previous group under the same conditions mentioned above.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study of two independent groups of people in parallel with different types of interventions, who are in hypobaric hypoxia conditions at the same time.
| Arm | Type | Receives |
|---|---|---|
| Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia | Active comparator | Other: Overload Exercise Protocol, Device: Bioimpedanciometry, Device: heart rate, Device: continuous glucose analysis, Biological: gut microbiota analysis, Device: Accelerometer, Other: Evaluation of sleep quality, using the Pittsburgh survey, Other: Quality of life survey SF36 v2., Procedure: Cardiac Variability Determination, Procedure: VO2 max estimate, Other: Encuesta alimentariaAll members of group G1 of "overload exercise intervention", an activity that will be carried out 3 times during the week, will have three data collection devices installed, which are: heart rate monitor belt on the chest, accelerometer on the right hip, and continuous glucose analyzer on the right triceps, which will carry out continuous data collection for 14 consecutive days. Along with this, this entire group will also undergo a battery of exams: body composition analysis, phase angle determination, fecal DNA extraction, venous blood sample and a Queens College physical box test, which will be carried out on day one, (at the beginning of the work shift) and later on day seven, (last day of the shift). Along with this, food surveys on consumption trends and 24-hour counts will be carried out. Similarly, a Pittsburgh survey and the SF36 V2 survey will be applied to the entire population. |
| Group undergoing resistance training plus probiotic intake. | Experimental | Dietary Supplement: Probiotic Nutritional Intervention, Other: Overload Exercise Protocol, Device: Bioimpedanciometry, Device: heart rate, Device: continuous glucose analysis, Biological: gut microbiota analysis, Device: Accelerometer, Other: Evaluation of sleep quality, using the Pittsburgh survey, Other: Quality of life survey SF36 v2., Procedure: Cardiac Variability Determination, Procedure: VO2 max estimate, Other: Encuesta alimentariaArm Description: Group G2 of "overload exercise intervention and probiotic intake" will receive a dose of two daily tablets of Karún Life probiotics. Along with this, three data collection devices will be installed: a heart rate monitor belt on the chest, an accelerometer on the right hip, and a continuous glucose analyzer on the right triceps, which will carry out continuous data collection for 14 consecutive days. Along with this, this entire group will also undergo a battery of tests: body composition analysis, phase angle determination, fecal DNA extraction, venous blood sample and a Queens College physical box test, which will be carried out on day one, (at the beginning of the work shift) and later on day seven, (last day of the shift). Along with this, food surveys on consumption trends and 24-hour counts will be carried out. Similarly, a Pittsburgh survey and the SF36 V2 survey will be applied to the entire population. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be an employee of the ALMA Observatory, Chile.
- Reside in the AOS (5,000 m above sea level) or OSF (2,950 m above sea level) sectors.
- Have more than one year of employment history.
Key exclusion criteria (4 listed)
- Individuals with pacemakers.
- Individuals only temporarily residing in observatory areas located in the Antofagasta Region.
- Pregnant women.
- Individuals with metal implants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Nutritional InterventionAlso: Gut Microbiota Under Hypobaric HypoxiaThe entire group will be supplemented with a known dose of 2 tablets daily of the probiotic "Karún Life" for 2 weeks (during the work week and the subsequent week of rest). | Dietary supplement | Group undergoing resistance training plus probiotic intake. |
| Overload Exercise ProtocolAlso: physical exercise, overload exercise, exercises under hypobaric hypoxia conditionsOn the first day of sampling, muscle strength will be evaluated using arm and back dynamometry. Along with this, "the maximum repetition" (1RM) of the pectoral, quadriceps, biceps and gastrocnemius muscle groups will be determined, with their values recorded on the record. Subsequently, an exercise protocol will be carried out during day 2-4-6 of the work day, using eccentric muscle contraction exercises, with 50% of the maximum weight achieved in the initial tests, in the same muscle groups previously evaluated, through 3 series with 10 repetitions each. ending the intervention with a new dynamometry evaluation of the arms, back and MRI in these muscle groups. | Other | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| BioimpedanciometryAlso: Body Composition, fat mass, free fat mass, BioimpedanciómetryDetermination of body composition and phase angle in both intervention groups (G1 and G2), during day one of the beginning of the work shift and the last day, both under conditions of intermittent hypobaric hypoxia. For which, the subjects will be placed with as little clothing as possible, without any metal on the body, with bare feet on the InBody Bioimpedancemeter, Model: 270S., with which fat mass, fat-free mass, total body water, intracellular water, extracellular water and phase angle will be calculated. | Device | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| heart rateA heart rate monitor belt, POLAR brand, model H10, will be installed on all subjects in both groups, for 14 continuous days (seven days in conditions of hypobaric hypoxia and 7 days in normobaric conditions), equipment that will remain connected to the accelerometer that the participants will have, in order to record their heart rate along with the intensity of movement. | Device | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| continuous glucose analysisAlso: glicemias continua, monitor de glicemia continuaOn the first day after the start of the work shift, a FreeStyle brand continuous glucose measurement patch will be installed in the area of the right triceps, which will be removed on the 14th (after the return of a new work shift), with which it is expected to know the glucose curves of people who perform work under conditions of intermittent hypobaric hypoxia between 2950 meters above sea level and 5050 meters above sea level. | Device | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| gut microbiota analysisAlso: Gut microbiomaA small sample of feces will be requested from each individual on day 1 at the start of the work shift and on day 7 at the end of the shift. Bacterial DNA will be extracted from these samples according to the manufacturer's protocol (QIAGEN_QIAamp PowerFecal Pro DNA Kit), which will be frozen to be sent to the GEMA laboratory of the Catholic University of Maule, where they will be sequenced in a Bioptic Fragment Analyzer processor (QSep 1). | Biological | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| AccelerometerAlso: Accelerometry, energy expenditure, moviment intensityOn the first day of the start of the work shift, an elastic belt with an Actigraph brand accelerometer, model wgt3x-bt, will be installed, which will be attached to the body on the right hip of each subject under study. This device will be removed on the 14th day of use, with which it is expected to quantify the intensity of the subject's movement, both during their work days and days of rest (between 2950 meters above sea level and 5050 meters above sea level). | Device | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| Evaluation of sleep quality, using the Pittsburgh surveyAlso: Cuestionario PittsburgA private survey will be carried out with each of the subjects being evaluated, using a survey to determine the quality of sleep of each person in conditions of intermittent hypobaric hypoxia called the Pittsburg Scale, an activity that will be carried out on a single occasion, during the work shift. | Other | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| Quality of life survey SF36 v2.Also: Quality of lifeLike the other surveys, we will use the SF32 V2 survey to develop the level of quality of life of each evaluated subject. This survey will be carried out privately, with an ONLINE questionnaire only once during the work shift. | Other | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| Cardiac Variability DeterminationAlso: Variabilidad CardiacaDuring the first day of stay in conditions of hypobaric hypoxia, taking advantage of the H10 heart rate monitor installed in each subject together with the KUBIOS HRV application and an OMROM blood pressure meter, the evaluation of cardiac variability will be carried out, an activity that will be carried out in the clinic adapted for this work, for which, a time outside of work will be organized, during a rest time, (due to the protocol of the test). This evaluation is secondary to the study | Procedure or surgery | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| VO2 max estimateDuring the initial physical evaluations, you will undergo a physical test called the modified Queens Box, (in a 20 cm high box with a test duration of 3 minutes), in which the person must step up to the box and down from it in pulses of 96 per minute for men and 88 for women. The pulses obtained by the subject evaluated using the installed Polar H10 heart rate monitor will be recorded on a record at the end of the test, at minute 1, 2 and 3 once the test is finished. | Procedure or surgery | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
| Encuesta alimentariaAlso: consumer trend survey, 24-hour recall surveyDuring a day different from the initial evaluations, two personal surveys related to diet will be carried out on each study subject, which will be carried out by a qualified nutritionist professional. These surveys will provide valuable information on the eating habits of the study subjects during their working hours under conditions of hypobaric hypoxia and during their rest days. | Other | Group undergoing resistance training plus probiotic intake., Overload Exercise Protocol on Inflammatory Parameters in Subjects Under Hypobaric Hypoxia |
Primary outcome
Aerobic Fitness, (ml/kg/min oxygen utilization)
Time frame: day 1 and 7 of the work shift
A modified Queens College box test (20 centimeter box height for 3 minutes) will be performed. Men will perform the test at 90 pulses per minute, while women will perform the test at a speed of 88 pulses per minute, for 3 minutes. Once the time is up, the participant's final pulse will be recorded using the POLAR H10 heart rate monitor, to later determine the aerobic capacity of each subject in ml/kg/min.
Glucose Curve (mg/dl)
Time frame: from the beginning of the work shift up to 14 consecutive days
To determine the constant metabolic status of circulating glucose of the study subjects, a continuous glucose analyzer will be installed in each of them in the triceps area of the right arm, using the Abbott FreeStyle Libre analysis monitor. For which the triceps area will be cleaned with cotton and 75% alcohol to later install the measurement patch, which must remain for 14 continuous days, so it will be removed on day 14 (when each person returns to a new work shift). With this analysis, it is expected to know the behavior of plasma glucose in mg/dl.
Body Composition (%fat mass, %free fat mass, %total body water)
Time frame: day 1 and 7 of the work shift
Determination of body composition by percentage of fat mass, percentage of fat-free mass, percentage of total body water, (extracellular water, intracellular water and phase angle). To do this, the patient will be asked to remove all metal elements from the body along with as much clothing as possible. To carry out this entire evaluation, the InBody brand bioimpedance meter, model 270S, will be used.
Food surveys
Time frame: day 2 of the work shift
Two dietary surveys will be carried out, the first is called "Evaluation of food consumption trends", while the second is a "24-hour intake count", with which macronutrients can be determined in grams.
Evaluation of movement intensity (METS/hora)
Time frame: from day 1 of the work shift to day 14
The quantification of the movement of each of the subjects under study will be carried out through the use of an Actigraph accelerometer, model wgt3x-bt. Equipment that will be installed using an elastic belt on the right hip of each of the study subjects, which will determine the intensity of the movement, due to the intensity peaks that can be demonstrated in counts per minute, this information will give us the METs/hour of each of the study subjects.
Heart Rate Quantification
Time frame: from day 1 of the work shift to day 14
A POLAR heart rate monitor, model H10, will be used to maintain constant monitoring of each of the study subjects. This equipment will be installed on the chest of each individual, which must be in direct contact with the skin using an elastic belt, below the sternum, indicating pulses/minute.
Muscle Strength (1RM)
Time frame: Day 1 of the work shift and day 7 of the shift
Upper body strength evaluations will be carried out, through the use of hand dynamometers and another to determine back strength. Along with this, a calculation of one repetition maximum (1RM) will be carried out for the muscle groups: Pectorals, Quadriceps, biceps and hamstrings. Once these values are recorded, the study subjects from both groups will undergo an overload exercise program, in the same muscle groups mentioned above, using a format of 3 sets for 10 repetitions in each muscle group at 50% of 1RM, for 3 days of the work week, every 48 hours.
1 secondary outcome
Cardiac Variability
Time frame: Day 1 of the work shift and day 7 of the shift
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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- Individual participant dataSharing planned: Undecided. Sharing the data of the patients with whom this research will be carried out will depend on whether the participant himself accepts, through informed consent, to share his studied background with the scientific community.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
jorge H Torres Mejías, Magister principal investigator
Centro de Investigación Andino para la Altitud Geográfica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Probiotic Nutritional Intervention, Overload Exercise Protocol and Bioimpedanciometry in people with Changes in the Intestinal Microbiota Under Hypobaric Hypoxia Conditions and Changes in Blood Glucose Under Hypobaric Hypoxia Conditions, run by Jorge Torres Mejías at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Fitness, (ml/kg/min oxygen utilization) (time frame: day 1 and 7 of the work shift). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07624409, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.