EXploratory Study on Postprandial Energy Metabolism

NCT06786052 | Recruiting Phase 2

• 1 other identifier: L-029
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Overweight; Moderately Obese

Keywords

Metabolic health; Probiotics; Postprandial metabolism

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (27)

• Change in vital parameter

  12 weeks

• Change in vital parameter

  12 weeks

• Change in anthropometric measurement

  12 weeks

• Change in anthropometric measurement

  12 weeks

• Change in blood lipid concentrations from baseline

  12 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

The product contains the probiotic strain and no other ingredients.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

The control product is a placebo with the same characteristics of appearance and packaging as the tested product.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

After randomization, participants will consume the probiotic for 3 months.

Probiotic

Placebo DIETARY_SUPPLEMENT

After randomization, participants will consume the placebo for 3 months.

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• Adult subject to a legal protection measure (guardianship, curatorship);
• 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;

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• Centre de recherche en nutrition humaine de Rhône-Alpes: collaborator

Study Sites (1)

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

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

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Saly El Salti, MSc

CONTACT

514-699-1799; selsalti@lallemand.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 22, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)