Inflammatory ResponseINDIEXNCT04315376
Exercise and Diet Intervention Attenuated Inflammation Through ASC Gene and Inflammatory Markers in Obese Adults
A study testing Exercise-Diet Intervention and Diet Intervention in people with Inflammatory Response and Obesity, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Background: Obesity is one of the most important health problems worldwide, several factors related to lifestyle as physical inactivity and unbalanced diets increase their development. This condition is characterized by low-chronic inflammation by excess of adipose tissue. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Obesity, Abdominal Obesity
- What is being tested?
- Exercise-Diet Intervention and Diet Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteMexico
- Study dates
- 10 Feb 2018to 15 Feb 2019
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI greater than 30 kg/m^2
- Sedentary individuals
- Both genres
- Waist circumference greater than 80 centimeters in women and greater than 90 centimeters in men
Who cannot join
- Pregnant or breastfeeding women
- Diagnosis of any metabolic disease or cancer
- Alcohol or tobacco consumption
- Muscle or joint injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Program and Diet Intervention Attenuated Inflammation Through Down-regulation of ASC Gene and Inflammatory Markers in Obese Adults
Background: Obesity is one of the most important health problems worldwide, several factors related to lifestyle as physical inactivity and unbalanced diets increase their development. This condition is characterized by low-chronic inflammation by excess of adipose tissue. The apoptosis-associated speck-like protein containing a caspase recruitment domain (ASC) protein is part of NLRP3 inflammasome, a complex related to inflammation and metabolic alterations.
Purpose: The aim of this study was to evaluate the effect of physical exercise program on ASC gene expression and inflammatory markers in obese adults.
Methods: 37 obese individuals were randomized to exercise-diet group or diet-group during a 4-month follow-up period. The dietary evaluation was analyzed by Nutritionist Pro software. Body composition was evaluated by bioimpedance (InBody 370). All biochemical determinations were analyzed by dry chemistry (Vitros 350). ASC messenger ribonucleic acid (mRNA) expression was performed by real-time polymerase chain reaction (PCR) using Taqman probes and by the 2-ΔΔcq quantification method. Cytokine levels was performed using the Bio-PlexPro™ HumanTh17Cytokine Assays (MagPix) panel. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS) v.22 software.
Read the detailed description
A randomized clinical trial was conducted in the Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology in Medicine, Health Sciences Center, at the University of Guadalajara, Guadalajara, Jalisco, Mexico, from February of 2018 to February of 2019. All participants were recruited through flyers and social media invitations. Sample size was determined according to the mean difference formula for clinical trials. To achieve a statistical power of 80% and an alpha of 5%, a sample size of 13 participants in each study group was required. However, 37 obese individuals who met the selection criteria were randomized in exercise-diet group or diet-group. Blood sample, height and weight were measured after 8-12 hour fast and wearing light clothes. The participants in the exercise-diet group were cited in the Respiratory Unit of the University of Guadalajara with the indication of not consuming caffeine, tobacco or energy drinks 24 hours before the test, and not having eaten food at least two hours before the Astrand-rhyming Test. This study was approved by the Ethics and Biosafety Committee of the Health Sciences Center, University of Guadalajara (registry number CUCS/CINV/0476/18). The procedures were in accordance with this institution's guidelines and all the participants signed a written consent-informed.
- Conditions
- Inflammatory Response, Obesity, Abdominal Obesity, Diet Habit, Exercise
- Being tested
- Exercise-Diet Intervention, Diet Intervention
- Keywords
- Nutrition, Exercise, Diet, Inflammation, Obesity
- Medical subject headings
- Obesity, Obesity, Abdominal, Feeding Behavior, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-Diet InterventionBehavioural
The participants who performed exercise-diet intervention performed an Astrand-rhyming test before and after the exercise program intervention. Participants followed a progressive exercise-program during four months according to initial physical fitness. The main exercises consisted of improving aerobic, speed and resistance performance. During all single sessions, breathlessness and fatigue were measured using 0 to10 Borg scale. A personal trainer certified by American College of Sports Medicine (ACSM) supervised three sessions per week, the other two unsupervised training days the subjects were given the detailed training program to do in house/park. And also, this group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins.
Diet InterventionBehavioural
This group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins.
| Study group | Role | What they receive |
|---|---|---|
| Exercise-Diet Group | Experimental | The participants receive a personal exercise program according to Astrand-rhyming test baseline results, and a hypo-caloric diet intervention Receives: Behavioral: Exercise-Diet Intervention |
| Diet Group | Active comparator | The participants no receive a personal exercise program, only the hypo-caloric diet Receives: Behavioral: Diet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ASC mRNA Expression
The polymorphonuclear cells were separated using Dextran treatment from peripheral blood samples. Subsequently, TRIzol® reagent was using according to the manufacturer´s instructions. The complementary DNA (cDNA) synthesis was performed according to standard techniques.
Quantitative real-time PCR was performed using TaqMan® probes in Light Cycler 96 equipment considering standards PCR conditions to analyze ASC mRNA relative expression by 2-ΔΔcq method. The amplification reactions were performed in duplicate using β-Actin gene as constitutive gene to normalized the samples.
Measured: Mean change from baseline (0 Month) to end of treatment at 4th Month.
Change in Pro-inflammatory and Anti-inflammatory Cytokines
The pro-inflammatory and anti-inflammatory cytokines quantification were using Bio-Plex Pro™ Human cytokine Standard 17-Plex, Group I kit following the supplier's instructions, and the read was immediately by MAGPIX™ analyzer.
Measured: Mean change from baseline (0 Month) to end of treatment at 4th Month.
Change in Astrand-rhyming Submaximal Test
The Astrand-rhyming submaximal test was performed as described by Astrand.
Measured: Mean change from baseline (0 Month) to end of treatment at 4th Month.
Secondary outcomes (12)
Changes in Height
Height in meters using a stadiometer.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month. 1st month, 2nd month, 3th month and the 4th month.
Changes in Weight
The weight was measured in kilograms on InBody 370.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Body Mass Index (BMI)
Weight and height were be combined to report BMI in kg/m^2
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Waist Circumference
Waist circumference was measured at the narrowest point between the edge of the inner rib and the iliac crest, with the participant in an abducted and relaxed position, after expiration using a Lufkin Executive® tape.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Fat Mass
The Fat Mass was measured in kilograms by electrical bioimpedance on InBody 370.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Musculoskeletal Mass
The musculoskeletal mass was measured in kilograms by electrical bioimpedance on InBody 370.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Serum Glucose
It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Serum Insulin
Were determined through Insulin Model ELISA kit following the supplier's instructions.
Measured: At the baseline (0 Month), 3th month and the 4th month.
Changes in homeostatic model assessment - insulin resistance (HOMA-IR)
Serum glucose and Insulin levels were be combined to report HOMA-IR calculated as described by Matthews.
Measured: At the baseline (0 Month), 3th month and the 4th month.
Changes in Total Cholesterol
It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in High-density lipoprotein (c-HDL)
It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Atherogenic Index
Serum total cholesterol and c-HDL were be combined to report atherogenic index, calculated through formula [Total cholesterol (mg/dL) / HDL-c (mg/dL)].
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start10 Feb 2018
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERIKA MARTINEZ-LOPEZ, University of Guadalajara
- Investigators
- Erika Martínez-López, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315376
- Sponsor's protocol ID
- CI-08518
- Acronym
- INDIEX
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared to protect and safeguard the confidentiality data of the participants.
Publications
ASTRAND PO, RYHMING I. A nomogram for calculation of aerobic capacity (physical fitness) from pulse rate during sub-maximal work. J Appl Physiol. 1954 Sep;7(2):218-21. doi: 10.1152/jappl.1954.7.2.218. No abstract available.
PubMed 13211501Lin CH, Chiang SL, Tzeng WC, Chiang LC. Systematic review of impact of lifestyle-modification programs on metabolic risks and patient-reported outcomes in adults with metabolic syndrome. Worldviews Evid Based Nurs. 2014 Dec;11(6):361-8. doi: 10.1111/wvn.12069.
PubMed 25488565Ozaki E, Campbell M, Doyle SL. Targeting the NLRP3 inflammasome in chronic inflammatory diseases: current perspectives. J Inflamm Res. 2015 Jan 16;8:15-27. doi: 10.2147/JIR.S51250. eCollection 2015.
PubMed 25653548Ross R, Hudson R, Stotz PJ, Lam M. Effects of exercise amount and intensity on abdominal obesity and glucose tolerance in obese adults: a randomized trial. Ann Intern Med. 2015 Mar 3;162(5):325-34. doi: 10.7326/M14-1189.
PubMed 25732273Taniguchi S, Sagara J. Regulatory molecules involved in inflammasome formation with special reference to a key mediator protein, ASC. Semin Immunopathol. 2007 Sep;29(3):231-8. doi: 10.1007/s00281-007-0082-3. Epub 2007 Sep 6.
PubMed 17805543You T, Arsenis NC, Disanzo BL, Lamonte MJ. Effects of exercise training on chronic inflammation in obesity : current evidence and potential mechanisms. Sports Med. 2013 Apr;43(4):243-56. doi: 10.1007/s40279-013-0023-3.
PubMed 23494259Barron-Cabrera E, Gonzalez-Becerra K, Rosales-Chavez G, Mora-Jimenez A, Hernandez-Canaveral I, Martinez-Lopez E. Low-grade chronic inflammation is attenuated by exercise training in obese adults through down-regulation of ASC gene in peripheral blood: a pilot study. Genes Nutr. 2020 Aug 27;15(1):15. doi: 10.1186/s12263-020-00674-0.
PubMed 32854610
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Program and Diet Intervention Attenuated Inflammation Through Down-regulation of ASC Gene and Inflammatory Markers in Obese Adults
- ClinicalTrials.gov ID
- NCT04315376
- Acronym / sponsor ID
- INDIEX / CI-08518
- Conditions
- Inflammatory Response, Obesity, Abdominal Obesity, Diet Habit, Exercise
- Keywords
- Nutrition, Exercise, Diet, Inflammation, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 19 Mar 2020 (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.
Background: Obesity is one of the most important health problems worldwide, several factors related to lifestyle as physical inactivity and unbalanced diets increase their development. This condition is characterized by low-chronic inflammation by excess of adipose tissue. The apoptosis-associated speck-like protein containing a caspase recruitment domain (ASC) protein is part of NLRP3 inflammasome, a complex related to inflammation and metabolic alterations.
Purpose: The aim of this study was to evaluate the effect of physical exercise program on ASC gene expression and inflammatory markers in obese adults.
Methods: 37 obese individuals were randomized to exercise-diet group or diet-group during a 4-month follow-up period. The dietary evaluation was analyzed by Nutritionist Pro software. Body composition was evaluated by bioimpedance (InBody 370). All biochemical determinations were analyzed by dry chemistry (Vitros 350). ASC messenger ribonucleic acid (mRNA) expression was performed by real-time polymerase chain reaction (PCR) using Taqman probes and by the 2-ΔΔcq quantification method. Cytokine levels was performed using the Bio-PlexPro™ HumanTh17Cytokine Assays (MagPix) panel. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS) v.22 software.
Detailed description
A randomized clinical trial was conducted in the Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology in Medicine, Health Sciences Center, at the University of Guadalajara, Guadalajara, Jalisco, Mexico, from February of 2018 to February of 2019. All participants were recruited through flyers and social media invitations. Sample size was determined according to the mean difference formula for clinical trials. To achieve a statistical power of 80% and an alpha of 5%, a sample size of 13 participants in each study group was required. However, 37 obese individuals who met the selection criteria were randomized in exercise-diet group or diet-group. Blood sample, height and weight were measured after 8-12 hour fast and wearing light clothes. The participants in the exercise-diet group were cited in the Respiratory Unit of the University of Guadalajara with the indication of not consuming caffeine, tobacco or energy drinks 24 hours before the test, and not having eaten food at least two hours before the Astrand-rhyming Test. This study was approved by the Ethics and Biosafety Committee of the Health Sciences Center, University of Guadalajara (registry number CUCS/CINV/0476/18). The procedures were in accordance with this institution's guidelines and all the participants signed a written consent-informed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise-Diet Group | Experimental | Behavioral: Exercise-Diet InterventionThe participants receive a personal exercise program according to Astrand-rhyming test baseline results, and a hypo-caloric diet intervention |
| Diet Group | Active comparator | Behavioral: Diet InterventionThe participants no receive a personal exercise program, only the hypo-caloric diet |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI greater than 30 kg/m^2
- Sedentary individuals
- Both genres
- Waist circumference greater than 80 centimeters in women and greater than 90 centimeters in men
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- Diagnosis of any metabolic disease or cancer
- Alcohol or tobacco consumption
- Muscle or joint injury
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 |
|---|---|---|
| Exercise-Diet InterventionThe participants who performed exercise-diet intervention performed an Astrand-rhyming test before and after the exercise program intervention. Participants followed a progressive exercise-program during four months according to initial physical fitness. The main exercises consisted of improving aerobic, speed and resistance performance. During all single sessions, breathlessness and fatigue were measured using 0 to10 Borg scale. A personal trainer certified by American College of Sports Medicine (ACSM) supervised three sessions per week, the other two unsupervised training days the subjects were given the detailed training program to do in house/park. And also, this group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins. | Behavioural | Exercise-Diet Group |
| Diet InterventionThis group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins. | Behavioural | Diet Group |
Primary outcome
Change in ASC mRNA Expression
Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month.
The polymorphonuclear cells were separated using Dextran treatment from peripheral blood samples. Subsequently, TRIzol® reagent was using according to the manufacturer´s instructions. The complementary DNA (cDNA) synthesis was performed according to standard techniques. Quantitative real-time PCR was performed using TaqMan® probes in Light Cycler 96 equipment considering standards PCR conditions to analyze ASC mRNA relative expression by 2-ΔΔcq method. The amplification reactions were performed in duplicate using β-Actin gene as constitutive gene to normalized the samples.
Change in Pro-inflammatory and Anti-inflammatory Cytokines
Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month.
The pro-inflammatory and anti-inflammatory cytokines quantification were using Bio-Plex Pro™ Human cytokine Standard 17-Plex, Group I kit following the supplier's instructions, and the read was immediately by MAGPIX™ analyzer.
Change in Astrand-rhyming Submaximal Test
Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month.
The Astrand-rhyming submaximal test was performed as described by Astrand.
12 secondary outcomes
Changes in Height
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month. 1st month, 2nd month, 3th month and the 4th month.
Changes in Weight
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Body Mass Index (BMI)
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Waist Circumference
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Fat Mass
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Musculoskeletal Mass
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Serum Glucose
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Serum Insulin
Time frame: At the baseline (0 Month), 3th month and the 4th month.
Changes in homeostatic model assessment - insulin resistance (HOMA-IR)
Time frame: At the baseline (0 Month), 3th month and the 4th month.
Changes in Total Cholesterol
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in High-density lipoprotein (c-HDL)
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Atherogenic Index
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Results publication: PubMed 13211501ASTRAND PO, RYHMING I. A nomogram for calculation of aerobic capacity (physical fitness) from pulse rate during sub-maximal work. J Appl Physiol. 1954 Sep;7(2):218-21. doi: 10.1152/jappl.1954.7.2.218. No abstract available.
- Results publication: PubMed 25488565Lin CH, Chiang SL, Tzeng WC, Chiang LC. Systematic review of impact of lifestyle-modification programs on metabolic risks and patient-reported outcomes in adults with metabolic syndrome. Worldviews Evid Based Nurs. 2014 Dec;11(6):361-8. doi: 10.1111/wvn.12069.
- Results publication: PubMed 25653548Ozaki E, Campbell M, Doyle SL. Targeting the NLRP3 inflammasome in chronic inflammatory diseases: current perspectives. J Inflamm Res. 2015 Jan 16;8:15-27. doi: 10.2147/JIR.S51250. eCollection 2015.
- Results publication: PubMed 25732273Ross R, Hudson R, Stotz PJ, Lam M. Effects of exercise amount and intensity on abdominal obesity and glucose tolerance in obese adults: a randomized trial. Ann Intern Med. 2015 Mar 3;162(5):325-34. doi: 10.7326/M14-1189.
- Results publication: PubMed 17805543Taniguchi S, Sagara J. Regulatory molecules involved in inflammasome formation with special reference to a key mediator protein, ASC. Semin Immunopathol. 2007 Sep;29(3):231-8. doi: 10.1007/s00281-007-0082-3. Epub 2007 Sep 6.
- Results publication: PubMed 23494259You T, Arsenis NC, Disanzo BL, Lamonte MJ. Effects of exercise training on chronic inflammation in obesity : current evidence and potential mechanisms. Sports Med. 2013 Apr;43(4):243-56. doi: 10.1007/s40279-013-0023-3.
- Derived from this study: PubMed 32854610Barron-Cabrera E, Gonzalez-Becerra K, Rosales-Chavez G, Mora-Jimenez A, Hernandez-Canaveral I, Martinez-Lopez E. Low-grade chronic inflammation is attenuated by exercise training in obese adults through down-regulation of ASC gene in peripheral blood: a pilot study. Genes Nutr. 2020 Aug 27;15(1):15. doi: 10.1186/s12263-020-00674-0.
- Individual participant dataSharing planned: No. The individual participant data will not be shared to protect and safeguard the confidentiality data of the participants.
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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.
Erika Martínez-López, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-Diet Intervention and Diet Intervention in people with Inflammatory Response and Obesity, run by University of Guadalajara at 1 site in Mexico.
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 4 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: finished, as of the sponsor's last update on 19 Mar 2020. 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 Mexico. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in ASC mRNA Expression (time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month.). The study lists 3 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 NCT04315376, which also lists 7 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 19 Mar 2020.