Dairy Lipids and Cardiometabolic Risk (DAILICATE)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Morbid Obesity

Treatments: Other: Low-fat dairy products; Other: Milk polar lipid enriched whole-fat dairy products; Other: Whole-fat dairy products

Study type: Interventional

Funder types: Other

Identifiers

NCT05783466

2022-A02415-38 (Other Identifier)

69HCL22_0461

Details and patient eligibility

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Low-fat dairy products within a dietary handling for weight loss

Other group

Description:

3 servings/day of low-fat dairy products: 1 serving of low-fat cheese, 1 serving of low-fat yogurt and 1 serving of (semi-)skimmed milk.

Treatment:

Other: Low-fat dairy products

Whole-fat dairy products within a dietary handling for weight loss

Experimental group

Description:

3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk.

Treatment:

Other: Whole-fat dairy products

Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss

Experimental group

Description:

3 servings/day of whole-fat dairy products (1 milk, 1 yogurt, 1 cheese) among which 1 serving/day is enriched with milk polar lipids via butterier.

Treatment:

Other: Milk polar lipid enriched whole-fat dairy products