Obesity and OverweightPhase 2EXPEMNCT06786052
EXploratory Study on Postprandial Energy Metabolism
A Phase 2 study testing Probiotic in people with Obesity and Overweight and Moderately Obese, run by Lallemand Health Solutions at 1 site in France.
Trial summary
This exploratory, double-blinded clinical trial on 66 randomized adults aged 50 to 70 years with moderate overweight or obesity but considered metabolically healthy will consist of comparing metabolic and microbiota parameters before and after 3 months of consumption of a probiotic or a placebo. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight, Moderately Obese
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2025to Feb 2028
- Phase
- Phase 2
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman;
- Age between 50 and 70 years old (inclusively);
- Postmenopausal women, i.e. with amenorrhea for more than a year with no identified cause
- BMI between 27 and 34.9 kg/m2 (inclusively);
- Stable weight in the last 3 months (+/- 5% of total body weight);
- Waist circumference ≥ 80 cm for women, ≥ 94 cm for men;
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- Sedentary to moderately active (less than 30 minutes of moderate physical activity, 3 times a week);
- Agreeing not to consume fermented or supplemented foods (including bifidus yogurts and other foods supplemented with probiotics), dietary supplements (high in fiber (prebiotics), high protein, or other food supplements that may interact with the gut microbiota or energy metabolism), laxatives and any substance that can control metabolic parameters such as weight, blood glucose or lipid metabolism during the study period (from the screening visit);
- Agreeing to receive probiotics or placebo supplementation randomly;
- Able to understand the information given, read and write in French and have signed the informed consent form;
- Agreeing to submit to the entire study protocol;
- Having fibre consumption (through diet or supplementation) of less than 30g/day;
- Having a freezer to store stool samples before the visit.
Who cannot join
- Participant with unstable medical or psychological conditions that, in the opinion of the investigator, could lead the participant to be non-compliant or uncooperative during the study or that could compromise the safety or participation in the study (according to articles L.1121-6, L.1121-8, L.1121-9 and L1122-1-2 of the Public Health Code);
- Presence of pathology detectable on clinical examination and medical questioning that may interfere with the study endpoints;
- Alcohol consumption exceeding 30g of alcohol/day (1 dose of alcoholic beverage = 10g of alcohol) or abuse or dependence on another proven drug;
- Tobacco consumption (or vaping equivalent) > to 5 cigarettes per day and inability to restrict smoking or vaping on the exploratory days provided for in the protocol;
- Failure to comply with the exclusion period for another study specified in the "national volunteer file";
- Adult subject to a legal protection measure (guardianship, curatorship);
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- Person deprived of liberty by a judicial or administrative decision;
- Person who has exceeded the annual amount of compensation in the year for participation in research protocols;
- Person not affiliated to a social security system or beneficiary of a similar system;
- Absence of valid approved health proof(s) in the event of government measures in an exceptional epidemic situation;
- Person with a specific diet (vegetarian, lacto-vegetarian, vegan, high-protein, etc.);
- People consuming food supplements (pre or probiotics, or minerals (divalent cations such as magnesium and calcium)) regularly during the month prior to the screening visit;
- Blood donation within 2 months prior to the screening visit;
- Claustrophobic to the point that indirect calorimetry measurement cannot be done;
- Person with limited venous access that can make it difficult to draw blood and insert a catheter;
- Type 1 or 2 diabetes;
- Systolic blood pressure ≥140 mmHg measured during the screening visit and mean systolic blood pressure from self-measurement over 3 days ≥140 mmHg;
- Diastolic blood pressure≥ 90 mmHg measured during the screening visit and mean diastolic blood pressure from self-measurement over 3 days ≥90 mmHg;
- Treatment for hypertension or dyslipidemia;
- Known endocrine pathology that may interfere with carbohydrate metabolism (uncontrolled dysthyroidism, acromegaly, hypercorticism, etc.);
- People with gastrointestinal pathologies with an inflammatory component or associated with malabsorption;
- People suffering from bloody diarrhoea;
- Exocrine pancreatic insufficiency;
- People who have had intestinal or abdominal surgery (apart from appendectomy and simple hernias), bariatric surgery (gastric banding, calibrated vertical gastroplasty and sleeve gastrectomy accepted if done more than 5 years ago);
- Severe eating disorders (e.g., anorexia/bulimia, uncontrolled binge eating syndrome, noctophagia);
- Chronic kidney failure;
- Hepatocellular insufficiency;
- Immunocompromised individuals (e.g., those with AIDS, lymphoma, patients on long-term corticosteroid therapy, patients undergoing chemotherapy and allogeneic transplants);
- Patients with central venous catheters and post-surgical patients;
- Hematological, gastrointestinal, hepatic, neurological, or psychiatric clinically significant according to the investigator;
- Drug treatments for obesity in the last 3 months or prescribed for the duration of the study;
- Taking antibiotics in the month preceding the explorations (for the so-called common antibiotics of the beta-lactam family) or in the 3 months preceding the explorations according to the investigator's judgment (for other families of antibiotics) except for certain types of antibiotics, particularly local or single-dose antibiotics: antibiotic eye drops (Oflocet), topical ointments (Fucidin), single-dose treatments (Monuril), and single-dose fosfomycin;
- Taking antidepressants in the 2 months prior to the explorations or prescribed for the duration of the study;
- Daily intake of laxatives in the 3 months prior to explorations or other medications that may strongly interfere with the composition of the gut microbiota;
- Taking a treatment that may interfere with the study measures, according to the judgment of the co-investigating physicians of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
Pierre-Bénite, Auvergne-Rhône-Alpes, 69310
Louise SECONDA, PhD, +33 4 78 86 39 94, ext-louise.seconda@chu-lyon.fr
Anne-Laure CASTELL, MD
About this study
Official title: Efficacy of Probiotics on Postprandial Energy Metabolism of Adults With Overweight or Obesity: an EXploratory Clinical Trial
This exploratory, double-blinded clinical trial on 66 randomized adults aged 50 to 70 years with moderate overweight or obesity but considered metabolically healthy will consist of comparing metabolic and microbiota parameters before and after 3 months of consumption of a probiotic or a placebo.
Read the detailed description
This study will focus on adults (men and postmenopausal women) aged 50 to 70 years who are overweight or moderately obese (BMI between 27 and 34.9 kg/m2) and considered metabolically healthy.
66 participants will be recruited according to the following inclusion and exclusion criteria. There will be a total of 5 visits and the study participation will last about 3.5 months.
The main hypothesis is that daily supplementation of the probiotics for 3 months in the defined population will improve certain parameters related to the cardiometabolic profile such as glucose tolerance and lipemia during the postprandial phase, compared to the placebo group.
- Conditions
- Obesity and Overweight, Moderately Obese
- Being tested
- Probiotic, Placebo
- Keywords
- Metabolic health, Probiotics, Postprandial metabolism
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
After randomization, participants will consume the probiotic for 3 months.
PlaceboDietary supplement
After randomization, participants will consume the placebo for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | The product contains the probiotic strain and no other ingredients. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | The control product is a placebo with the same characteristics of appearance and packaging as the tested product. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in postprandial triglyceridemia after 3 months
The difference (delta) from baseline in the area under the incremental curve (AUCi (0-300 min)) of postprandial triglyceridemia in response to a test meal after 12 weeks of probiotic supplementation versus placebo.
Measured: 12 weeks
Secondary outcomes (27)
Change in vital parameter
Changes in pulse measured at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress.
Measured: 12 weeks
Change in vital parameter
Change in blood pressure measured at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress.
Measured: 12 weeks
Change in anthropometric measurement
BMI calculated in kg/m^2 by measuring the weight and height at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress.
Measured: 12 weeks
Change in anthropometric measurement
Waist-to-hip ratio calculated by measuring the waist and hip circumference at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress.
Measured: 12 weeks
Change in blood lipid concentrations from baseline
Blood samples will be collected at each visit to report lipid concentrations such as plasma/serum triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol and non-esterified fatty acids.
Measured: 12 weeks
Change in blood metabolic parameters from baseline
Blood samples will be collected at each visit to report metabolic parameters such as glucose, insulin, Hba1c and ApoB.
Measured: 12 weeks
Change in body composition
Changes in body composition at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress. It is measured using multifrequency bio-impedancemetry which quantifies the total body water and the percentages of lean and fat mass.
Measured: 12 weeks
Change in inflammatory parameters
Changes in the plasma concentrations of TNF-α, IL6, and CRP measured at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals for CRP.
Measured: 12 weeks
Change in intestinal barrier integrity biomarker
Change in the plasma concentration of Zonuline measured at baseline and at the end of intervention.
Measured: 12 weeks
Change in safety plasma concentration
Blood samples will be taken each visit in order to report safety plasma concentration, which includes the measurements of creatinine, GFR, urea, AST, ALT, gamma GT, bilirubin, albumin, and PAL.
Measured: 12 weeks
Change in fasting exhaled gases
Changes in the levels of CO2, H2, and CH4 measured at baseline and at the end of intervention.
Measured: 12 weeks
Change in complete blood count
Changes in the complete blood count measured throughout the intervention period.
Measured: 12 weeks
Change in gut microbiota
Collected stool samples will be used for microbiota analysis, which allows to assess changes in the composition and diversity of the gut microbiota throughout the intervention period, as well as probiotic strain detection.
Measured: 12 weeks
Change in postprandial kinetics of metabolic parameters
Changes in the maximum and minimum values during the postprandial period for the following parameters: glucose (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), insulin (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), and total cholesterol (time t0, 30, 60, 120, 180, 240, 300 min).
Measured: 12 weeks
Change in postprandial kinetics of metabolic parameters
Changes in the peak or nadir times during the postprandial period for the following parameters: glucose (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), insulin (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), and total cholesterol (time t0, 30, 60, 120, 180, 240, 300 min).
Measured: 12 weeks
Change in postprandial kinetics of metabolic parameters
Changes in the total and incremental AUCs 0-120 min, 120-300 min, and 0-300 min during the postprandial period for the following parameters: glucose (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), insulin (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), and total cholesterol (time t0, 30, 60, 120, 180, 240, 300 min).
Measured: 12 weeks
Change in postprandial kinetics of metabolic parameters
Changes in kinetics of the following parameters measured at specific time points: glucose (t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), insulin (t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), and total cholesterol (t0, 30, 60, 120, 180, 240, 300 min).
Measured: 12 weeks
Change in postprandial triglyceride levels and kinetics
Change in the maximum and minimum values as well as times at peak or nadir, total AUC 0-120 min, 120-300 min, 0-300 min during the postprandial period and triglyceride kinetics (time t0, 30, 60, 120, 180, 240, 300 min).
Measured: 12 weeks
Change in plasma metabolome
Change in the plasma metabolome (about 1000 metabolites from 39 different classes) measured throughout the intervention period.
Measured: 12 weeks
Assessment of average daily food intake
Assessing the average daily food intake of macronutrients and micronutrients using 3-day dietary surveys of the week prior to a visit.
Measured: 12 weeks
Change in resting energy metabolism
Change in resting energy metabolism measured by indirect calorimetry at baseline and at the end of intervention.
Measured: 12 weeks
Assessment of digestive tolerance
Evaluation of digestive tolerance via Gastrointestinal Symptom Assessment Scale throughout the intervention period.
Measured: 12 weeks
Evaluation of changes in stool assessment
Evaluation of the change in stool consistency and frequency reported via Bristol and Likert scale throughout the intervention period.
Measured: 12 weeks
Physical Activity Assessment
Physical activity assessed throughout the intervention period using International Physical Activity Questionnaire (IPAQ).
Measured: 12 weeks
Evaluation of eating behaviour
Eating behaviour and satietogenic effect will be assessed throughout the intervention period using Three-Factor Eating Questionnaire (TFEQ-R21) and Food Cravings Questionnaires (FCQ-T and FCQ-S).
Measured: 12 weeks
Assessment of general well-being
General well-being assessed throughout the intervention period using 36-Item Short Form Health Survey (SF-36) questionnaire.
Measured: 12 weeks
Assessment of stress level
General stress level assessed throughout the intervention period using Perceived Stress Scale (PSS) questionnaire.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start7 Apr 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786052
- Sponsor's protocol ID
- L-029
- Acronym
- EXPEM
- Status last verified
- May 2025
- First submitted
- 8 Jan 2025
- Last updated
- 28 May 2026
- Results posted
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotics on Postprandial Energy Metabolism of Adults With Overweight or Obesity: an EXploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT06786052
- Acronym / sponsor ID
- EXPEM / L-029
- Conditions
- Obesity and Overweight, Moderately Obese
- Keywords
- Metabolic health, Probiotics, Postprandial metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 22 Jan 2025 (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.
This exploratory, double-blinded clinical trial on 66 randomized adults aged 50 to 70 years with moderate overweight or obesity but considered metabolically healthy will consist of comparing metabolic and microbiota parameters before and after 3 months of consumption of a probiotic or a placebo.
Detailed description
This study will focus on adults (men and postmenopausal women) aged 50 to 70 years who are overweight or moderately obese (BMI between 27 and 34.9 kg/m2) and considered metabolically healthy.
66 participants will be recruited according to the following inclusion and exclusion criteria. There will be a total of 5 visits and the study participation will last about 3.5 months.
The main hypothesis is that daily supplementation of the probiotics for 3 months in the defined population will improve certain parameters related to the cardiometabolic profile such as glucose tolerance and lipemia during the postprandial phase, compared to the placebo group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticThe product contains the probiotic strain and no other ingredients. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe control product is a placebo with the same characteristics of appearance and packaging as the tested product. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Man or woman;
- Age between 50 and 70 years old (inclusively);
- Postmenopausal women, i.e. with amenorrhea for more than a year with no identified cause
- BMI between 27 and 34.9 kg/m2 (inclusively);
- Stable weight in the last 3 months (+/- 5% of total body weight);
Key exclusion criteria (35 listed)
- Participant with unstable medical or psychological conditions that, in the opinion of the investigator, could lead the participant to be non-compliant or uncooperative during the study or that could compromise the safety or participation in the study (according to articles L.1121-6, L.1121-8, L.1121-9 and L1122-1-2 of the Public Health Code);
- Presence of pathology detectable on clinical examination and medical questioning that may interfere with the study endpoints;
- Alcohol consumption exceeding 30g of alcohol/day (1 dose of alcoholic beverage = 10g of alcohol) or abuse or dependence on another proven drug;
- Tobacco consumption (or vaping equivalent) > to 5 cigarettes per day and inability to restrict smoking or vaping on the exploratory days provided for in the protocol;
- Failure to comply with the exclusion period for another study specified in the "national volunteer file";
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 |
|---|---|---|
| ProbioticAfter randomization, participants will consume the probiotic for 3 months. | Dietary supplement | Probiotic |
| PlaceboAfter randomization, participants will consume the placebo for 3 months. | Dietary supplement | Placebo |
Primary outcome
Change from baseline in postprandial triglyceridemia after 3 months
Time frame: 12 weeks
The difference (delta) from baseline in the area under the incremental curve (AUCi (0-300 min)) of postprandial triglyceridemia in response to a test meal after 12 weeks of probiotic supplementation versus placebo.
27 secondary outcomes
Change in vital parameter
Time frame: 12 weeks
Change in vital parameter
Time frame: 12 weeks
Change in anthropometric measurement
Time frame: 12 weeks
Change in anthropometric measurement
Time frame: 12 weeks
Change in blood lipid concentrations from baseline
Time frame: 12 weeks
Change in blood metabolic parameters from baseline
Time frame: 12 weeks
Change in body composition
Time frame: 12 weeks
Change in inflammatory parameters
Time frame: 12 weeks
Change in intestinal barrier integrity biomarker
Time frame: 12 weeks
Change in safety plasma concentration
Time frame: 12 weeks
Change in fasting exhaled gases
Time frame: 12 weeks
Change in complete blood count
Time frame: 12 weeks
Change in gut microbiota
Time frame: 12 weeks
Change in postprandial kinetics of metabolic parameters
Time frame: 12 weeks
Change in postprandial kinetics of metabolic parameters
Time frame: 12 weeks
Change in postprandial kinetics of metabolic parameters
Time frame: 12 weeks
Change in postprandial kinetics of metabolic parameters
Time frame: 12 weeks
Change in postprandial triglyceride levels and kinetics
Time frame: 12 weeks
Change in plasma metabolome
Time frame: 12 weeks
Assessment of average daily food intake
Time frame: 12 weeks
Change in resting energy metabolism
Time frame: 12 weeks
Assessment of digestive tolerance
Time frame: 12 weeks
Evaluation of changes in stool assessment
Time frame: 12 weeks
Physical Activity Assessment
Time frame: 12 weeks
Evaluation of eating behaviour
Time frame: 12 weeks
Assessment of general well-being
Time frame: 12 weeks
Assessment of stress level
Time frame: 12 weeks
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 28 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Obesity and Overweight and Moderately Obese, run by Lallemand Health Solutions at 1 site in France.
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 13 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 28 May 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Crystèle Hogue, MSc (+1 514 223 5565, chogue@lallemand.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in postprandial triglyceridemia after 3 months (time frame: 12 weeks). 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 28 May 2026.