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

NCT01472666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2016-03-01

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

High content of MC-SFA

12 weeks dietary intervention

DIETARY_SUPPLEMENT

Whey

12 weeks dietary intervention

DIETARY_SUPPLEMENT

Low content of MC-SFA

12 weeks dietary intervention

DIETARY_SUPPLEMENT

Casein

12 weeks dietary intervention

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER
  • Arla Foods

    collaborator INDUSTRY
  • Wageningen University

    collaborator OTHER
  • University of Dublin, Trinity College

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Kjeld Hermansen, Professor · Aarhus University Hospital

  • Hanne C Bertram, Scientist · Department of Food Science, University of Aarhus

  • Lorraine O'Driscoll, Professor · School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin, Ireland

  • Michael Müller, Professor · Division of Human Nutrition, Wageningen University, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01472666 on ClinicalTrials.gov