Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05783466

Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity

Led by Hospices Civils de Lyon · Updated on 2025-06-18

75

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Hospices Civils de Lyon

Lead Sponsor

L

Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of different types of dairy products on adults with severe obesity in this randomized study. The purpose is to see if daily consumption of whole dairy products enriched with milk polar lipids can reduce fasting plasma apolipoprotein B levels more than low-fat dairy products during a 3-month weight loss diet. This study focuses on cardiometabolic risk factors related to obesity. Participants are divided into three groups receiving different dairy product regimens for three months: low-fat dairy (cheese, yogurt, milk), whole-fat dairy, and whole-fat dairy enriched with milk polar lipids through butter. Each group consumes three servings daily as part of a dietary weight loss plan. The study compares these interventions to assess their impact on metabolic health. During the study, participants undergo assessments before and after the 3-month intervention, including fasting and post-meal blood tests to measure metabolic markers, body weight, body composition, and inflammation indicators. Questionnaires on physical activity, digestive comfort, satiety, food intake, and product appreciation are also completed. Researchers closely monitor changes in plasma lipid and glucose levels at multiple time points, as well as intestinal microbiota and immune cell markers, to understand the effects of these dairy products on cardiometabolic health.

CONDITIONS

Brief Title

Dairy Lipids and Cardiometabolic Risk

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women between 18 and 70 years old
  • Body Mass Index (BMI) between 35 and 60 kg/m2 inclusive
  • Stable body weight with less than 5% change in the last 3 months
  • Consume at least one serving per day of dairy products made from cow's milk
  • Provide informed consent to participate
Not Eligible

You will not qualify if you...

  • History of bariatric or digestive surgery or digestive diseases affecting study outcomes
  • Drinking more than 3 glasses of alcohol daily (over 30g/day)
  • Pregnancy, recent childbirth, or breastfeeding
  • Allergies or intolerance to dairy products
  • Following vegetarian, lactovegetarian, or high protein diets
  • Use of dietary supplements
  • Use of lipid-lowering drugs within 6 weeks before study start
  • Treatment with insulin, GLP-1 analogs, acarbose, corticoids, or beta-blockers
  • Medication affecting intestinal microbiota in past 3 months or laxative use
  • Smoking 5 or more cigarettes per day in the past 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants receive 3 servings per day of assigned dairy products within a dietary handling for weight loss for 3 months. The dairy products include low-fat dairy, whole-fat dairy, or whole-fat dairy enriched with milk polar lipids.

2 visits (baseline and end of intervention, in-person)

Trial Site Locations

Total: 2 locations

1

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Pierre-Bénite, France, 69310

Active, Not Recruiting

2

Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition

Pierre-Bénite, France, 69310

Actively Recruiting

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Research Team

E

Emmanuel DISSE, Pr

M

MArie-Caroline MICHALSKI, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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