Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05783466

Dairy Lipids and Cardiometabolic Risk

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

75

Participants Needed

2

Research Sites

170 weeks

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

It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group). Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.

CONDITIONS

Official 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 18-70 years
  • Body Mass Index (BMI) between 35 and 60 kg/m2 inclusive
  • Stable body weight (weight change +/- 5 % for 3 months prior to screening)
  • Consumption of at least 1 serving/day of dairy products made from cow's milk
  • Informed consent
Not Eligible

You will not qualify if you...

  • History of bariatric or digestive surgery or disease interfering with main outcomes
  • Drinking more than 3 glasses of alcohol per day (>30g/day)
  • Pregnancy, parturiency or breastfeeding
  • Food allergies or intolerance to dairy products
  • Dietary restriction (vegetarian or lactovegetarian) or high protein diet
  • Use of dietary supplements
  • Treated with lipid lowering drugs (fibrates, statins, anti-PCSK9, ezetimibe, cholestyramine) within the last 6 weeks before study entry
  • Treated with insulin, GLP-1 analogs, acarbose, corticoids, beta-blockers
  • Medications interfering with intestinal microbiota (beta-lactamines within 3 months before the study or laxatives)
  • Smoking ≥ 5 cigarettes/day during the past 6 months.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

Research Team

E

Emmanuel DISSE, Pr

CONTACT

M

MArie-Caroline MICHALSKI, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here