Actively Recruiting

Phase 2
Age: 50Years - 70Years
All Genders
Healthy Volunteers
NCT06786052

EXploratory Study on Postprandial Energy Metabolism

Led by Lallemand Health Solutions · Updated on 2025-05-09

66

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

Sponsors

L

Lallemand Health Solutions

Lead Sponsor

C

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

EXploratory Study on Postprandial Energy Metabolism

Who Can Participate

Age: 50Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Man or woman
  • Age between 50 and 70 years old (inclusive)
  • Postmenopausal women with amenorrhea for more than a year without identified cause
  • BMI between 27 and 34.9 kg/m2 (inclusive)
  • Stable weight in the last 3 months (+/- 5% of total body weight)
  • Waist circumference 2 80 cm for women, 2 94 cm for men
  • Sedentary to moderately active (less than 30 minutes of moderate physical activity, 3 times a week)
  • Agree not to consume fermented or supplemented foods, dietary supplements that may interact with gut microbiota or energy metabolism, laxatives, or substances controlling metabolic parameters during the study
  • Agree to receive probiotics or placebo supplementation randomly
  • Able to understand French and have signed informed consent
  • Agree to follow the entire study protocol
  • Fiber consumption less than 30g/day
  • Have a freezer to store stool samples before visits
Not Eligible

You will not qualify if you...

  • Unstable medical or psychological conditions that could affect compliance or safety
  • Presence of pathology interfering with study endpoints
  • Alcohol consumption exceeding 30g/day or substance abuse
  • Tobacco or vaping more than 5 cigarettes per day and inability to restrict during study
  • Non-compliance with exclusion period for other studies
  • Subject to legal protection measures
  • Person deprived of liberty
  • Exceeded annual compensation limit for research participation
  • Not affiliated with social security system
  • No valid health proof in case of epidemic measures
  • Specific diets such as vegetarian, vegan, or high-protein
  • Regular consumption of food supplements (prebiotics, probiotics, minerals) in month prior to screening
  • Blood donation within 2 months prior to screening
  • Claustrophobia preventing indirect calorimetry
  • Limited venous access complicating blood draws
  • Type 1 or 2 diabetes
  • Systolic blood pressure 2 140 mmHg
  • Diastolic blood pressure 2 90 mmHg
  • Treatment for hypertension or dyslipidemia
  • Known endocrine disorders affecting carbohydrate metabolism
  • Gastrointestinal inflammatory or malabsorption diseases
  • Bloody diarrhea
  • Exocrine pancreatic insufficiency
  • Intestinal or abdominal surgery except appendectomy and simple hernias; bariatric surgery accepted if over 5 years ago
  • Severe eating disorders
  • Chronic kidney failure
  • Liver failure
  • Immunocompromised status
  • Central venous catheters or recent surgery
  • Significant hematological, gastrointestinal, hepatic, neurological, or psychiatric conditions
  • Obesity drug treatment within last 3 months or during study
  • Antibiotic use in month prior or as judged by investigator
  • Antidepressant use in 2 months prior or during study
  • Daily laxative use or other medications interfering with gut microbiota
  • Other treatments interfering with study measurements as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)

Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69310

Actively Recruiting

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Research Team

S

Saly El Salti, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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