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

NCT ID: NCT01472666

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-12-31

Brief Summary

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.

Detailed Description

See above.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fat rich in MC-SFA

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

Group Type: EXPERIMENTAL

High content of MC-SFA

Intervention Type: DIETARY_SUPPLEMENT

12 weeks dietary intervention

Fat low on MC-SFA

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

Group Type: EXPERIMENTAL

Low content of MC-SFA

Intervention Type: DIETARY_SUPPLEMENT

12 weeks dietary intervention

Casein protein

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

Group Type: EXPERIMENTAL

Casein

Intervention Type: DIETARY_SUPPLEMENT

12 weeks dietary intervention

Whey protein

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

Group Type: EXPERIMENTAL

Whey

Intervention Type: DIETARY_SUPPLEMENT

12 weeks dietary intervention

Interventions

High content of MC-SFA

12 weeks dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

Whey

12 weeks dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

Low content of MC-SFA

12 weeks dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

Casein

12 weeks dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Arla Foods

INDUSTRY

Sponsor Role: collaborator

Wageningen University

OTHER

Sponsor Role: collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kjeld Hermansen, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Hanne C Bertram, Scientist

Role: STUDY_CHAIR

Department of Food Science, University of Aarhus

Lorraine O'Driscoll, Professor

Role: STUDY_CHAIR

School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin, Ireland

Michael Müller, Professor

Role: STUDY_CHAIR

Division of Human Nutrition, Wageningen University, The Netherlands

Locations

Aarhus University Hospital

Aarhus, Aarhus C, Denmark

Countries

Denmark

References

Bohl M, Bjornshave A, Rasmussen KV, Schioldan AG, Amer B, Larsen MK, Dalsgaard TK, Holst JJ, Herrmann A, O'Neill S, O'Driscoll L, Afman L, Jensen E, Christensen MM, Gregersen S, Hermansen K. Dairy proteins, dairy lipids, and postprandial lipemia in persons with abdominal obesity (DairyHealth): a 12-wk, randomized, parallel-controlled, double-blinded, diet intervention study. Am J Clin Nutr. 2015 Apr;101(4):870-8. doi: 10.3945/ajcn.114.097923. Epub 2015 Jan 14.

Reference Type: DERIVED

PMID: 25833983 (View on PubMed)

Other Identifiers

CERN-DairyHealth

Identifier Type: -

Identifier Source: org_study_id