An interventional study of Hypoxic High-Intensity Interval Training and Normoxic High-Intensity Interval Training in Obesity & Overweight and Fat Mass, sponsored by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques. Recruiting at 1 site in France. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 475 studies in Obesity with a site in France — 111 open to participants now, 127 under way, 25 of them phase 3. Obesity · France.
Among the 475 studies in Obesity with a site in France, this one is the 269th largest by planned enrollment of the 354 interventional ones that give a count, is one of 30 that started in 2026, is one of 258 with no phase, reaches primary completion later than 88 of the 126 other live ones, and was the 468th registered.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
Browse Obesity studies →111 of the 475 studies in Obesity with a site in France are open now. Recruiting first, the newest first:
AstraZeneca · Sites in France, United States, Argentina and 13 more countries
Ages 18+
Novo Nordisk A/S · Sites in France, United States, Belgium and 7 more countries
Ages 18+
Hospices Civils de Lyon · Sites in France
Ages 18–75
Universite du Littoral Cote d'Opale · Sites in France
Ages 18+
Nantes University Hospital · Sites in France
Ages 18–65
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.
This study: 50 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
475 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 21 · Phase 3 61 · Phase 4 14
First in 2001; this study’s year is marked. 30 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 32 is below the median of 67 across 9,010 interventional studies indexed under Obesity.
Median enrollment 80 across the 354 interventional studies, 133 across the 121 observational. Of the 295 that completed or were terminated, 16 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
76 of 475 have an industry lead sponsor. The 10 most frequent:
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques has 5 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
30 of the studies in Obesity with a site in France that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT03516968Phase 3Hospices Civils de LyonMonthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents | 2027-03 |
| NCT07220642Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide | 2027-05-11 |
| NCT07225686Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | 2027-08-20 |
Add all 30 to your calendar (.ics) → With an account.
Among the 475 studies in Obesity with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Overweight and obesity are major public health challenges worldwide, and their prevalence increases with age, partly because of age-related metabolic and hormonal changes. Beyond total fat mass, abdominal and particularly visceral fat accumulation is strongly associated with chronic low-grade inflammation, insulin resistance, hypertension and cardiovascular disease. Men are more likely to display an android fat distribution, while premenopausal women generally show a more protective gynoid distribution. However, declining sex hormone concentrations after menopause promote abdominal and visceral fat accumulation, increasing cardiometabolic risk.
Physical activity is a cornerstone of overweight and obesity management. High-intensity interval training (HIIT) is an effective strategy for reducing total, abdominal and visceral fat and may produce greater benefits than moderate-intensity continuous training. Since 2016, our team has conducted several studies and reviews showing that HIIT performed on a cycle ergometer or treadmill, alone or combined with resistance training, reduces total and abdominal fat mass in people with overweight or obesity, regardless of age, sex or hormonal status.
HIIT can also be performed under real or simulated hypoxic conditions to enhance cardiovascular, respiratory, circulatory, haematological and skeletal muscle adaptations. The Live Low-Train High model allows participants to live under normoxic conditions while being exposed to hypoxia only during exercise. Hypoxic HIIT has proved feasible and safe in people with metabolic disorders or physical deconditioning, including at simulated altitudes of 4,000-5,000 m. However, only two studies have suggested that hypoxic HIIT may enhance fat mass loss in people with overweight or obesity. Neither specifically assessed abdominal or visceral fat, and neither focused on postmenopausal women.
Several mechanisms may contribute to HIIT-induced fat loss, including increased catecholaminergic stimulation and lipid oxidation during recovery, excess post-exercise oxygen consumption and changes in appetite regulation. The gut microbiota may also contribute to the regulation of adipose tissue and cardiometabolic health. Physical activity can increase bacterial diversity and promote beneficial taxa, particularly short-chain fatty acid-producing bacteria. Our previous HIIT studies identified associations between changes in selected bacteria and reductions in total or abdominal fat mass. Hypoxic exposure may also alter gut microbiota composition and abundance, with effects depending on the severity and type of hypoxia.
This study will assess the effects of a 3-month cycle-ergometer HIIT programme, performed three times per week under hypoxic versus normoxic conditions, in adults aged 50-75 years with overweight or obesity. The primary objective is to determine whether hypoxic HIIT produces a greater reduction in abdominal and visceral fat mass than the same training performed in normoxia.
Secondary outcomes will include total and regional fat and lean mass; fasting glucose, insulin, HbA1c and HOMA-IR; total cholesterol, triglycerides, HDL-C, LDL-C, ApoB, ApoA1 and the ApoB/ApoA1 ratio; high-sensitivity C-reactive protein and fibrinogen; systolic and diastolic blood pressure; blood biophysical properties; and faecal microbiota richness, diversity and taxonomic composition. Lipid oxidation during prolonged moderate-intensity exercise, maximal oxygen uptake and maximal aerobic power will also be assessed before and after the intervention.
We hypothesise that hypoxic training will enhance improvements in body composition, metabolic and cardiovascular risk factors, aerobic fitness and lipid oxidation compared with normoxic training. We further hypothesise that hypoxia will modify faecal microbiota composition and that changes in selected bacterial taxa will be associated with changes in body composition and cardiovascular risk markers.
The ultimate aim is to improve the management of adults aged 50-75 years with overweight or obesity by developing an effective 3-month HIIT programme performed under controlled hypoxic conditions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged 50-75 years, inclusive Male or female, defined as no menstruation during the previous 12 months between 25 and 35 kg/m², inclusive Non-smoker or smoking no more than two cigarettes per day Stable body weight for at least three months before study initiation, defined as a change of less than 4 kg Stable dietary habits and physical activity level for at least three months before study initiation Willing to maintain usual dietary habits and physical activity level throughout the study Able and willing to comply with the study protocol Able and willing to provide written Affiliated with a social security scheme Willing to be registered in the French National Register of Volunteers Participating in Biomedical Research
Exclusion Criteria:
Medical or surgical history considered by the investigators to be incompatible with participation in the study Any medical condition considered by the investigators to be incompatible with participation in the study Medical to vigorous physical activity Current use of hormone replacement therapy Current use of beta-blocker therapy Diagnosed moderate-to-severe sleep apnoea syndrome that is untreated or inadequately controlled High-risk cardiovascular history, including symptomatic coronary artery disease, recent myocardial infarction or stroke, unstable heart failure, arrhythmia, or uncontrolled hypertension Severe respiratory disease, including advanced classified as group B or E according to the 2023 GOLD classification, chronic respiratory failure, or uncontrolled asthma Diabetes of any type Chronic kidney disease stage 3B, 4 or 5 according to the KDIGO classification Severe liver disease, defined by an greater than 1.2-1.3 Antibiotic treatment during the three months preceding the first stool collection More than eight hours of moderate-to-vigorous physical activity per week Any treatment that, in the investigators' opinion, could interfere with assessment of the study outcomes Low-energy diet during the three months preceding the study or intention to begin an energy-restricted diet during the study Extreme dietary habits Stay at an altitude above 2,500 m for more than eight days during the three months preceding the study Participation in another clinical study or currently within an exclusion period following participation in a previous clinical study Total compensation received for participation in research since the beginning of the calendar year exceeding €4,500, or the applicable regulatory limit Linguistic or psychological inability to provide Refusal to provide written informed consent Legally protected adult Deprived of liberty by an administrative or judicial decision Under guardianship or curatorship
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will complete a 12-week cycle-ergometer HIIT programme, with three sessions per week, under normobaric hypoxia (FiO₂: 15%; simulated altitude: 3,000 m).
Behavioral: Hypoxic High-Intensity Interval Training
Participants will complete the same 12-week cycle-ergometer HIIT programme, with three sessions per week, under normoxic conditions (FiO₂: 21%).
Behavioral: Normoxic High-Intensity Interval Training
Participants will complete 36 cycle-ergometer HIIT sessions over 12 weeks (three sessions per week) under normobaric hypoxia (FiO₂: 15%; simulated altitude: 3,000 m). Each session will include a 5-minute warm-up followed by 60 repetitions of 8 seconds of acceleration at approximately 80-85 rpm and 12 seconds of deceleration at approximately 60 rpm. The 8-second efforts will be performed at 75-80% of maximal aerobic power.
Also known as: Hypoxic HIIT, HIIT-H
Participants will complete 36 cycle-ergometer HIIT sessions over 12 weeks (three sessions per week) under normoxic conditions (FiO₂: 21%). Each session will include a 5-minute warm-up followed by 60 repetitions of 8 seconds of acceleration at approximately 80-85 rpm and 12 seconds of deceleration at approximately 60 rpm. The 8-second efforts will be performed at 75-80% of maximal aerobic power.
Also known as: Normoxic HIIT, HIIT-N
Relative Change in Total Abdominal Fat Mass
Total abdominal fat mass will be measured by dual-energy X-ray absorptiometry (DXA) at baseline and after the 12-week intervention. The relative change will be calculated as: (abdominal fat mass at 12 weeks - abdominal fat mass at baseline) / abdominal fat mass at baseline. More negative values indicate a greater reduction in abdominal fat mass. The change will be compared between the hypoxic and normoxic HIIT groups.
Time frame: Baseline and immediately after the 12-week intervention
Relative Change in Body Mass
Description: Body mass will be measured in kilograms at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between the hypoxic and normoxic HIIT groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in Visceral Abdominal Fat Mass
Description: Visceral abdominal fat mass will be measured by DXA at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in Total Lean Mass
Description: Total lean mass will be measured in kilograms by DXA at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in Waist-to-Hip Ratio
Description: The waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in metabolic Plasma parameters (TG, HBA1C, glucose, insulin, HDL, LDL)
Fasting concentration will be measured at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in Whole Blood Viscosity
Whole blood viscosity will be assessed using standardised haemorheological procedures at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in Red Blood Cell Deformability
Description: Red blood cell deformability will be assessed using standardised haemorheological procedures at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in Red Blood Cell Aggregation
Description: Red blood cell aggregation will be assessed using standardised haemorheological procedures at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Change in the Relative Abundance of Prespecified Gut Bacterial Taxa
Description: The relative abundance of prespecified bacterial taxa will be determined from faecal microbiota samples collected at baseline and after the 12-week intervention. Changes in relative abundance will be compared between the hypoxic and normoxic HIIT groups.
Time frame: Baseline and after 12 weeks of intervention
Change in Faecal Gut Microbiota Alpha Diversity
Description: Alpha-diversity indices reflecting within-sample bacterial richness and diversity will be calculated from faecal microbiota samples collected at baseline and after the 12-week intervention. Changes will be compared between the hypoxic and normoxic HIIT groups.
Time frame: Baseline and after 12 weeks of intervention
Change in Faecal Gut Microbiota Beta Diversity
Description: Beta diversity, reflecting differences in bacterial community composition, will be assessed using faecal samples collected at baseline and after the 12-week intervention. Changes in community composition will be compared between the hypoxic and normoxic HIIT groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in Maximal Aerobic Power
Description: Maximal aerobic power, expressed in watts, will be determined during a maximal exercise test at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in Lipid Oxidation Rate During Submaximal Exercise
Description: Lipid oxidation rate, expressed in grams per minute, will be calculated by indirect calorimetry during 45 minutes of fasted exercise performed at 50% of V̇O₂max, at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Relative Change in Carbohydrate Oxidation Rate During Submaximal Exercise
Description: Carbohydrate oxidation rate, expressed in grams per minute, will be calculated by indirect calorimetry during 45 minutes of fasted exercise performed at 50% of V̇O₂max, at baseline and after the 12-week intervention. Relative change will be calculated as: (week 12 value - baseline value) / baseline value and compared between groups.
Time frame: Baseline and after 12 weeks of intervention
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 22 months after the start.
Of 3,683 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 22 months is close to that.
Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques