Overweight and ObesityLOWSNCT04801810
Daily Low Oxygen Exposure and Weight Status
A study testing Normobaric hypoxia and Normobaric normoxia in people with Overweight and Obesity, run by Florida State University at 1 site in United States.
Trial summary
The objective of this single-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calorie restriction (CR, -500 kcal/d) in combination with either overnight… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Normobaric hypoxia and Normobaric normoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men and women aged 20 - 50 years
- Overweight or obese (BMI between 27.5-34.9 kg/m2)
- Born at altitudes less than 2,100 meters (~7,000 feet)
- Currently residing in Tallahassee, Florida, or the surrounding area
- Not taking any medication(s) that interfere with metabolism or oxygen delivery/transport for 4 weeks prior to and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers, and/or any medication that depresses ventilation, diuretics, alpha, and beta-blockers).
- Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study
- Willing to have a hypoxic tent set-up in their home and spend 8 consecutive hours per night in the tent for 8 weeks
- Lives with a family member, partner/spouse, or roommate who can hear and respond in the unlikely event that the blood oxygen, air oxygen, or air carbon dioxide monitoring alarm would sound.
Who cannot join
- Living in areas that are more than 1,200 m (~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders, and any condition that interferes with metabolism or oxygen delivery/transport (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Evidence of apnea or other sleeping disorders
- Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
- Diagnosis or family history of sickle cell anemia/trait
- Hematocrit <42% for males, <36% for females
Show all 15Show fewer
- Hemoglobin <13 g/dL for males, <12 g/dL for females
- Blood donation within 8 weeks of beginning the study
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Allergies or intolerance to foods included in the standardized and ad libitum meal tests (e.g., lactose intolerance/milk allergy)
- Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle in the past 6 mo.
- Weight gain or loss > 10% of body weight during the past 6 months
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Effects of Daily Low Oxygen Exposure on Weight Status, Body Composition, and Metabolic Health
The objective of this single-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calorie restriction (CR, -500 kcal/d) in combination with either overnight exposure (8 h/night) to normobaric hypoxia (NH; 15% oxygen, ~8500 ft elevation) or normoxia (NN; 21% oxygen, sea level), using a commercially available, in-home tent system, in adults who are overweight or obese.
Read the detailed description
The current research study will evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calorie restriction (CR, -500 kcal/d) in combination with either overnight exposure to normobaric hypoxia (NH) or normoxia (NN). Participants will be instructed to follow their normal diet but with a 500 kcal/day deficit as advised by a Registered Dietitian. Participants will spend 8 hours/night in a tent, set-up around their bed, in their home, for 8 weeks. Participants sleeping in the hypoxic tent (Hypoxico Inc., New York, NY, commercially available tents: https://hypoxico.com/) will breath ~15% oxygen (achieved with nitrogen dilution, equivalent to ~8500 ft elevation), whereas those in the control tent (Hypoxico Inc.) will breath ~21% oxygen (achieved with nitrogen dilution, equivalent to sea level elevation). Trained research staff will set-up the hypoxic or control tent system in each participant's home on day 0 and will visit the participant's home on days 1, 2, and 3 to check and/or adjust the tent settings. After day 3, research staff will visit the participant's home weekly to check and/or adjust the tent settings. participants will be weighed each morning following an overnight fast and morning void. Participants will come to the laboratory on two separate days for baseline testing (days -1 and 0) and again on two separate days at the end of the study (days 55 and 56) for endpoint testing.
- Conditions
- Overweight and Obesity
- Being tested
- Normobaric hypoxia, Normobaric normoxia
- Keywords
- Body weight, Normobaric hypoxia, Overwieght and obesity, Negative energy balance, Energy expenditure, Energy intake
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normobaric hypoxiaOther
Low oxygen exposure to mimic ~8500 feet elevation (experimental).
Normobaric normoxiaOther
Normal oxygen exposure to mimic sea level conditions (sham comparator).
| Study group | Role | What they receive |
|---|---|---|
| Normobaric hypoxia (NH) | Experimental | 8 weeks of overnight exposure (8 hrs/night) to NH conditions (~15% oxygen; achieved with nitrogen dilution, equivalent to ~8500 feet elevation) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY). Receives: Other: Normobaric hypoxia |
| Normobaric normoxia (NN) | Sham comparator | 8 weeks of overnight exposure (8 hrs/night) to NN conditions (~21% oxygen; sea level) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY). Receives: Other: Normobaric normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight
Body weight will be measured during baseline (days -7 to 0) and each morning during the study (days 1 to 56) following an overnight fast and morning void, using a calibrated digital scale provided to participants to use at home (A\&D Medical wireless weight scale UC-352BLE, San Jose, CA). Percent change in body weight will be calculated as:
[Body weight - baseline body weight (average of days -7 to 0)]/ baseline body weight * 100
Measured: 8 weeks (56 days)
Secondary outcomes (26)
Percent change in body weight
Body weight also will be measured 4 weeks after the study intervention ends to assess whether weight loss is sustained.
Measured: 4 weeks after intervention ends
4-compartment body composition using DEXA and deuterium dilution
Body composition will be determined following a 12 hour fast and morning void on day -1 and 55 using dual energy x-ray absorptiometry (DEXA, Discovery W, Hologic Inc., Bedford, MA or equivalent). The volunteer will remove all metal-containing objects from their body, lay face-up on the DEXA densitometer table in light clothing (t-shirt, shorts, socks), and be asked to remain motionless for the 8-10 min scan. A scanner emitting low energy x-rays and a detector will pass over the participant. These data will be used to calculate total body mass, fat-free mass, fat mass, and bone mass. Total body water will be measured following a 12 hour fast and 1 hour without water intake using the deuterium dilution method on days -1 and 55.
Measured: Days -1 and 55
Resting metabolic rate
Resting metabolic rate will be measured with open circuit, indirect calorimetry (ParvoMedics TrueOne 2400 metabolic cart, Sandy, UT) in the morning, upon arrival to the lab on days 0 and 56.
Measured: Days 0 and 56
Resting substrate oxidation
Resting substrate oxidation will be measured with open circuit, indirect calorimetry (ParvoMedics TrueOne 2400 metabolic cart, Sandy, UT) in the morning, upon arrival to the lab on days 0 and 56.
Measured: Days 0 and 56
Total daily energy intake
Participants will complete 3 dietary records (2 week days, 1 weekend day) prior to the in-person baseline visit and during weeks 1, 2, 4, 6, and 8 of the study using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. This web-based tool was developed by the National Cancer Institute: https://epi.grants.cancer.gov/asa24/.
Measured: Weeks -1, 1, 2, 4, 6, and 8
Total daily macronutrient intake
Participants will complete 3 dietary records (2 week days, 1 weekend day) prior to the in-person baseline visit and during weeks 1, 2, 4, 6, and 8 of the study using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. This web-based tool was developed by the National Cancer Institute: https://epi.grants.cancer.gov/asa24/.
Measured: Weeks -1, 1, 2, 4, 6, and 8
Ad libitum energy intake
Ad libitum energy intake will be assessed by measuring total energy intake during an ad libitum buffet-style meal provided to participants on days 0 and 56.
Measured: Days 0 and 56
Food preferences
Food preferences will be assessed by measuring macronutrient intake during an ad libitum buffet-style meal provided to participants on days 0 and 56.
Measured: Days 0 and 56
Heart rate variability
A 3-lead electrocardiogram will be conducted on days 0 and 56 to assess heart rate variability. Participants will have electrode patches placed on their chest to measure the electrical activity of the heart.
Measured: Days 0 and 56
Urinary epinephrine
On days -1, 13, and 55 urine will be collected during the overnight time period. Participants will void their bladder before entering the tent in the evening (they will not collect this portion). Participants will collect any urine produced throughout the night and will collect one final time in the morning after exiting the tent. Epinephrine concentrations in the urine samples will be measured.
Measured: Days -1, 13, and 55
Urinary norepinephrine
On days -1, 13, and 55 urine will be collected during the overnight time period. Participants will void their bladder before entering the tent in the evening (they will not collect this portion). Participants will collect any urine produced throughout the night and will collect one final time in the morning after exiting the tent. Norepinephrine concentrations in the urine samples will be measured.
Measured: Days -1, 13, and 55
Urinary dopamine
On days -1, 13, and 55 urine will be collected during the overnight time period. Participants will void their bladder before entering the tent in the evening (they will not collect this portion). Participants will collect any urine produced throughout the night and will collect one final time in the morning after exiting the tent. Dopamine concentrations in the urine samples will be measured.
Measured: Days -1, 13, and 55
Plasma glucose concentrations
A 75-g oral glucose tolerance test (OGTT) will be conducted on days 0 and 56. A venous catheter will be placed and blood samples obtained at -5, 30, 60, 90, and 120 min during the OGTT for measurements of plasma glucose and insulin concentration. Insulin sensitivity will be determined by using the whole-body insulin sensitivity index (WBISI), also known as the Matsuda Index.
Measured: Days 0 and 56
Plasma insulin concentrations
A 75-g oral glucose tolerance test (OGTT) will be conducted on days 0 and 56. A venous catheter will be placed and blood samples obtained at -5, 30, 60, 90, and 120 min during the OGTT for measurements of plasma glucose and insulin concentration. Insulin sensitivity will be determined by using the whole-body insulin sensitivity index (WBISI), also known as the Matsuda Index.
Measured: Days 0 and 56
Whole-body insulin sensitivity index
A 75-g oral glucose tolerance test (OGTT) will be conducted on days 0 and 56. A venous catheter will be placed and blood samples obtained at -5, 30, 60, 90, and 120 min during the OGTT for measurements of plasma glucose and insulin concentration. Insulin sensitivity will be determined by using the whole-body insulin sensitivity index (WBISI), also known as the Matsuda Index.
Measured: Days 0 and 56
Thermic effect of glucose
The thermic effect of glucose will be measured on study days 0 and 56 with open circuit, indirect calorimetry (2400 TrueOne, Parvo Medics) using established protocols. Resting metabolic rate measurements will be taken prior to glucose administration in a thermo-neutral room while the participant is in the supine position (as described above). During the oral glucose tolerance test the thermic effect of glucose will be measured in 15 min increments for 2 hours (15-30, 45-60, 75-90, and 105-120 minutes).
Measured: Days 0 and 56
Subjective appetite measures
Subjective appetite will be measured on study days 0 and 56. Subjectively rated appetite will be assessed immediately before the oral glucose tolerance test (OGTT) and at 15, 30, 45, 60, 90, and 120 minutes after beginning the OGTT using 100 mm visual analog scales to rate fullness, hunger, desire to eat, and prospective food consumption. Composite satiety score will be calculated from the individual appetite scores using the equation: CSS = (fullness + (100 - Desire to eat) + (100 - Hunger) + (100 - Prospective food consumption) / 4.
Measured: Days 0 and 56
Prevalence of acute mountain sickness
The prevalence and severity of acute mountain sickness (AMS) will be determined from information gathered using the shortened version of the Environmental Symptoms Questionnaire (ESQ) (5 min; 26 questions total). The minimum score is 0 and the maximum score is 5. A lower score indicates fewer AMS symptoms. At completion, oxygen saturation will be determined using finger pulse oximetry (PalmSAT® 2500A, Nonin Medical, Inc., Plymouth, MN). AMS and oxygen saturation measurements will be taken in the morning on days 0-7, 14, 21, 28, 35, 42, and 56.
Measured: Days 0-7, 14, 21, 28, 35, 42, and 56
Continuous overnight oxygen saturation
Oxygen saturation will be measured continuously overnight (8 h/night) using a finger pulse oximeter (PalmSAT® 2500, Nonin Medical, Inc., Plymouth, MN) during 8 weeks of overnight exposure to NH or NN.
Measured: 8 weeks (56 days)
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI; 5 minutes, 18 questions) will be used to examine volunteer sleep quality on days 0-7, 14, 28, 35, 42, and 56. The minimum score is 0 and the maximum score is 21. Lower scores indicate better sleep quality.
Measured: Days 0-7, 14, 28, 35, 42, and 56
24-hour continuous glucose concentrations
A continuous glucose monitor (Freestyle Libre Pro) will be inserted into the subcutaneous adipose tissue behind the arm and will be used to collect and assess 24-hour glucose concentrations during baseline (day -7 to day 0), days 1-14, and days 42-56.
Measured: Days -7 to 0, 1 to 14, and 42 to 56
24-hour glucose variability
A continuous glucose monitor (Freestyle Libre Pro) will be inserted into the subcutaneous adipose tissue behind the arm and will be used to collect and assess 24-hour glucose concentrations during baseline (day -7 to day 0), days 1-14, and days 42-56.
Measured: Days -7 to 0, 1 to 14, and 42 to 56
Blood volume
Blood volume will be determined using the optimized carbon monoxide rebreathing method on days -1 and 55. In this method, a capillary blood sample is taken, and basal carboxyhemoglobin concentrations will be determined using a blood gas analyzer. Carbon monoxide is then inhaled via a spirometer (SpiCo, Blood Tec.) for 2 minutes. Seven minutes after inhaling the carbon monoxide bolus, a second capillary blood sample is taken to determine the increase in carboxyhemoglobin concentration. The change in percentage of carboxyhemoglobin between the basal and second measurements can be used to calculate hemoglobin mass and blood volume.
Measured: Days -1 and 55
Fasting measures of iron status
Serum iron, total iron binding capacity, soluble transferrin receptor, hepcidin, hemoglobin, hematocrit, ferritin, erythroferrone, and erythropoietin will be measured in fasting blood samples collected on days 0 and 56.
Measured: Days 0 and 56
Psychosocial Factors
The Positive and Negative Affect Schedule, Cohen Perceived Stress Scale, Big Five Inventory-2, Delay Discounting questionnaire, Palatable Eating Motives Scale, and the Generalized Self-Efficacy scale will be administered on days -1, 14, and 55.
Measured: Days -1, 14, and 55
Fasting blood pressure
Fasting blood pressure will be measured on days 0 and 56 using an automated blood pressure cuff. All blood pressure readings will be taken on the right arm, and participants will be in a seated position, after resting for at least 5 minutes. Blood pressure will be measured in triplicate.
Measured: Days 0 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study startMay 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: This study was registered in conjunction with a submitted R01. To address reviewer comments, the study was changed substantially for resubmission. A new study has been registered (NCT05289310) that aligns with the funded R01.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire E. Berryman, Florida State University
- Investigators
- Claire E Berryman, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801810
- Sponsor's protocol ID
- STUDY00000334
- Acronym
- LOWS
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Low Oxygen Exposure on Weight Status, Body Composition, and Metabolic Health
- ClinicalTrials.gov ID
- NCT04801810
- Acronym / sponsor ID
- LOWS / STUDY00000334
- Conditions
- Overweight and Obesity
- Keywords
- Body weight, Normobaric hypoxia, Overwieght and obesity, Negative energy balance, Energy expenditure, Energy intake
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was registered in conjunction with a submitted R01. To address reviewer comments, the study was changed substantially for resubmission. A new study has been registered (NCT05289310) that aligns with the funded R01.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 17 Mar 2021 (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 single-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calorie restriction (CR, -500 kcal/d) in combination with either overnight exposure (8 h/night) to normobaric hypoxia (NH; 15% oxygen, ~8500 ft elevation) or normoxia (NN; 21% oxygen, sea level), using a commercially available, in-home tent system, in adults who are overweight or obese.
Detailed description
The current research study will evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calorie restriction (CR, -500 kcal/d) in combination with either overnight exposure to normobaric hypoxia (NH) or normoxia (NN). Participants will be instructed to follow their normal diet but with a 500 kcal/day deficit as advised by a Registered Dietitian. Participants will spend 8 hours/night in a tent, set-up around their bed, in their home, for 8 weeks. Participants sleeping in the hypoxic tent (Hypoxico Inc., New York, NY, commercially available tents: https://hypoxico.com/) will breath ~15% oxygen (achieved with nitrogen dilution, equivalent to ~8500 ft elevation), whereas those in the control tent (Hypoxico Inc.) will breath ~21% oxygen (achieved with nitrogen dilution, equivalent to sea level elevation). Trained research staff will set-up the hypoxic or control tent system in each participant's home on day 0 and will visit the participant's home on days 1, 2, and 3 to check and/or adjust the tent settings. After day 3, research staff will visit the participant's home weekly to check and/or adjust the tent settings. participants will be weighed each morning following an overnight fast and morning void. Participants will come to the laboratory on two separate days for baseline testing (days -1 and 0) and again on two separate days at the end of the study (days 55 and 56) for endpoint testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normobaric hypoxia (NH) | Experimental | Other: Normobaric hypoxia8 weeks of overnight exposure (8 hrs/night) to NH conditions (~15% oxygen; achieved with nitrogen dilution, equivalent to ~8500 feet elevation) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY). |
| Normobaric normoxia (NN) | Sham comparator | Other: Normobaric normoxia8 weeks of overnight exposure (8 hrs/night) to NN conditions (~21% oxygen; sea level) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women aged 20 - 50 years
- Overweight or obese (BMI between 27.5-34.9 kg/m2)
- Born at altitudes less than 2,100 meters (~7,000 feet)
- Currently residing in Tallahassee, Florida, or the surrounding area
- Not taking any medication(s) that interfere with metabolism or oxygen delivery/transport for 4 weeks prior to and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers, and/or any medication that depresses ventilation, diuretics, alpha, and beta-blockers).
Key exclusion criteria (15 listed)
- Living in areas that are more than 1,200 m (~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders, and any condition that interferes with metabolism or oxygen delivery/transport (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Evidence of apnea or other sleeping disorders
- Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
- Diagnosis or family history of sickle cell anemia/trait
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 |
|---|---|---|
| Normobaric hypoxiaLow oxygen exposure to mimic ~8500 feet elevation (experimental). | Other | Normobaric hypoxia (NH) |
| Normobaric normoxiaNormal oxygen exposure to mimic sea level conditions (sham comparator). | Other | Normobaric normoxia (NN) |
Primary outcome
Percent change in body weight
Time frame: 8 weeks (56 days)
Body weight will be measured during baseline (days -7 to 0) and each morning during the study (days 1 to 56) following an overnight fast and morning void, using a calibrated digital scale provided to participants to use at home (A\&D Medical wireless weight scale UC-352BLE, San Jose, CA). Percent change in body weight will be calculated as: [Body weight - baseline body weight (average of days -7 to 0)]/ baseline body weight * 100
26 secondary outcomes
Percent change in body weight
Time frame: 4 weeks after intervention ends
4-compartment body composition using DEXA and deuterium dilution
Time frame: Days -1 and 55
Resting metabolic rate
Time frame: Days 0 and 56
Resting substrate oxidation
Time frame: Days 0 and 56
Total daily energy intake
Time frame: Weeks -1, 1, 2, 4, 6, and 8
Total daily macronutrient intake
Time frame: Weeks -1, 1, 2, 4, 6, and 8
Ad libitum energy intake
Time frame: Days 0 and 56
Food preferences
Time frame: Days 0 and 56
Heart rate variability
Time frame: Days 0 and 56
Urinary epinephrine
Time frame: Days -1, 13, and 55
Urinary norepinephrine
Time frame: Days -1, 13, and 55
Urinary dopamine
Time frame: Days -1, 13, and 55
Plasma glucose concentrations
Time frame: Days 0 and 56
Plasma insulin concentrations
Time frame: Days 0 and 56
Whole-body insulin sensitivity index
Time frame: Days 0 and 56
Thermic effect of glucose
Time frame: Days 0 and 56
Subjective appetite measures
Time frame: Days 0 and 56
Prevalence of acute mountain sickness
Time frame: Days 0-7, 14, 21, 28, 35, 42, and 56
Continuous overnight oxygen saturation
Time frame: 8 weeks (56 days)
Sleep quality
Time frame: Days 0-7, 14, 28, 35, 42, and 56
24-hour continuous glucose concentrations
Time frame: Days -7 to 0, 1 to 14, and 42 to 56
24-hour glucose variability
Time frame: Days -7 to 0, 1 to 14, and 42 to 56
Blood volume
Time frame: Days -1 and 55
Fasting measures of iron status
Time frame: Days 0 and 56
Psychosocial Factors
Time frame: Days -1, 14, and 55
Fasting blood pressure
Time frame: Days 0 and 56
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Claire E Berryman, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normobaric hypoxia and Normobaric normoxia in people with Overweight and Obesity, run by Florida State University at 1 site in United States.
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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 1 Apr 2022. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent change in body weight (time frame: 8 weeks (56 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2022.