A Phase 2 interventional study of Probiotic and Placebo in Obesity and Overweight and Moderately Obese, sponsored by Lallemand Health Solutions. Recruiting at 1 site in France. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Lallemand Health Solutions · Phase 2, Interventional, and Health services research
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 66 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Lallemand Health Solutions is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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 weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
The product contains the probiotic strain and no other ingredients.
Dietary Supplement: Probiotic
The control product is a placebo with the same characteristics of appearance and packaging as the tested product.
Dietary Supplement: Placebo
After randomization, participants will consume the probiotic for 3 months.
After randomization, participants will consume the placebo for 3 months.
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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Change in intestinal barrier integrity biomarker
Change in the plasma concentration of Zonuline measured at baseline and at the end of intervention.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Change in complete blood count
Changes in the complete blood count measured throughout the intervention period.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 weeks
Change in plasma metabolome
Change in the plasma metabolome (about 1000 metabolites from 39 different classes) measured throughout the intervention period.
Time frame: 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.
Time frame: 12 weeks
Change in resting energy metabolism
Change in resting energy metabolism measured by indirect calorimetry at baseline and at the end of intervention.
Time frame: 12 weeks
Assessment of digestive tolerance
Evaluation of digestive tolerance via Gastrointestinal Symptom Assessment Scale throughout the intervention period.
Time frame: 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.
Time frame: 12 weeks
Physical Activity Assessment
Physical activity assessed throughout the intervention period using International Physical Activity Questionnaire (IPAQ).
Time frame: 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).
Time frame: 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.
Time frame: 12 weeks
Assessment of stress level
General stress level assessed throughout the intervention period using Perceived Stress Scale (PSS) questionnaire.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Feb 2028, 34 months after the start.
Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's planned 34 months is above that.
Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Probiotic
Lallemand Health Solutions