Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"

University of Aarhus

Status: Completed

Conditions: Abdominal Obesity; Type 2 Diabetes; Metabolic Syndrome; Cardiovascular Disease

Treatments: Dietary Supplement: Casein; Dietary Supplement: Low content of MC-SFA; Dietary Supplement: High content of MC-SFA; Dietary Supplement: Whey

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01472666

CERN-DairyHealth

Details and patient eligibility

About

Dairy food contains a large amount of long-chain saturated fat, which traditionally has been linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a more neutral role. Milk fat contains large amounts of medium-chain saturated fatty acids (MC-SFA), which may have beneficial effects on human health. In addition, milk proteins and in particular whey proteins have been shown to have a beneficial effect on glucose disposal as well as anti-inflammatory properties. Therefore dairy products have a potential role in the treatment of the metabolic abnormalities of metabolic syndrome (MeS). However, human data from intervention studies are lacking.

Aims of this project is to explore and understand the influence on human health of both medium-chain saturated fatty acids from milk fat and bioactive milk proteins per se as well as their interaction and potential positive synergy on the MeS.

The investigators hypothesize that whey protein and medium-chain saturated fatty acids improve insulin sensitivity, postprandial lipid metabolism, blood pressure and inflammatory stress in humans and that they possess preventive effects on the risk of developing CVD and type 2 diabetes mellitus (T2DM).

A total of 64 people with MeS or abdominal obesity will be included. The design is a randomized double-blinded, controlled parallel diet-intervention trial.

Subjects are assigned one of four experimental diets for 12 weeks. The diets consist of either a diet with low levels of MC-SFA + whey protein (LF + whey), a diet high in MC-SFA + whey protein (HF + whey), a diet high in MC-SFA + casein protein (HF + casein) or a diets with low levels of MC-SFA + casein protein (LF + casein). The subjects are advised how to integrate the test foods in their habitual diet, which also continues unchanged. The subjects' energy intake is matched so they are kept weight stable throughout the study.

Full description

See above.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Metabolic syndrome

• Central obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)
• with two or more of the following
• Fasting triglyceride > 1.7 mmol/l
• HDL-cholesterol; male < 1.03 mmol/l, female < 1.29 mmol/l
• BP ≥ 130/85
• Fasting plasma glucose ≥ 5,6 mmol/l (but not diabetes)

Or abdominal obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)

Exclusion criteria

• Significant cardiovascular, renal or endocrine disease
• Psychiatric history
• Treatment with steroids
• Alcohol- or drug-addiction
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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63 participants in 4 patient groups

Fat rich in MC-SFA

Experimental group

Description:

63 gram milk fat with high content of MC-SFA (C6-C12=8.5 g) incorporated in rolls, muffin and as butter.

Treatment:

Dietary Supplement: High content of MC-SFA

Fat low on MC-SFA

Experimental group

Description:

63 gram milkfat with low content of MC-SFA (C6-C12=6.9 g) incorporated in rolls, muffin and as butter

Treatment:

Dietary Supplement: Low content of MC-SFA

Casein protein

Experimental group

Description:

60 gram casein protein (Miprodan 30) ingested twice daily with 600 ml water.

Treatment:

Dietary Supplement: Casein

Whey protein

Experimental group

Description:

60 gram whey protein (Lacprodan DI-9224) ingested twice daily with 600 ml water.

Treatment:

Dietary Supplement: Whey