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Recruiting Phase 2 NCT06786052

NCT06786052 EXploratory Study on Postprandial Energy Metabolism

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Clinical Trial Summary
NCT ID NCT06786052
Status Recruiting
Phase Phase 2
Sponsor Lallemand Health Solutions
Condition Obesity and Overweight
Study Type INTERVENTIONAL
Enrollment 66 participants
Start Date 2025-04-07
Primary Completion 2028-02

Trial Parameters

Condition Obesity and Overweight
Sponsor Lallemand Health Solutions
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 66
Sex ALL
Min Age 50 Years
Max Age 70 Years
Start Date 2025-04-07
Completion 2028-02
Interventions
ProbioticPlacebo

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Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Man or woman; 2. Age between 50 and 70 years old (inclusively); 3. Postmenopausal women, i.e. with amenorrhea for more than a year with no identified cause 4. BMI between 27 and 34.9 kg/m2 (inclusively); 5. Stable weight in the last 3 months (+/- 5% of total body weight); 6. Waist circumference ≥ 80 cm for women, ≥ 94 cm for men; 7. Sedentary to moderately active (less than 30 minutes of moderate physical activity, 3 times a week); 8. 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); 9. Agreeing to receive probiotics or placebo supplementation randomly; 10. Able to und

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