NCT06786052

EXploratory Study on Postprandial Energy Metabolism

Efficacy of Probiotics on Postprandial Energy Metabolism of Adults With Overweight or Obesity: an EXploratory Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	After randomization, participants will consume the probiotic for 3 months.
DIETARY_SUPPLEMENT	Placebo	After randomization, participants will consume the placebo for 3 months.

Timeline

• Start date: 2025-04-07
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-01-22
• Last updated: 2025-05-09

Locations

1 site across 1 country: France