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

February 29, 2016 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See above.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus C
      • Aarhus, Aarhus C, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Dietary supplement: High content of MC-SFA
12 weeks dietary intervention
EXPERIMENTAL: 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
Dietary supplement: Low content of MC-SFA
12 weeks dietary intervention
EXPERIMENTAL: Casein protein
60 gram casein protein (Miprodan 30) ingested twice daily with 600 ml water.
Dietary supplement: Casein
12 weeks dietary intervention
EXPERIMENTAL: Whey protein
60 gram whey protein (Lacprodan DI-9224) ingested twice daily with 600 ml water.
Dietary supplement: Whey
12 weeks dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial triglyceride response
Time Frame: Change from week 0 to week 12
Compare the changes in mean difference of 6 hours incremental area under the curve (iAUC) (week 12 - week 0) between the groups and the intervention components.
Change from week 0 to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour blood pressure (BP)
Time Frame: Change from week 0 to week 12
Spacelabs, model 90207/90217, USA
Change from week 0 to week 12
Indirect calorimetry
Time Frame: Change from week 0 to week 12
Measured 2 times during meal test.
Change from week 0 to week 12
Dexa-scan (body composition)
Time Frame: Change from week 0 to week 12
Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight.
Change from week 0 to week 12
Weight
Time Frame: Change from week 0 to week 12
Change from week 0 to week 12
Biomarkers in blood samples
Time Frame: Change from week 0 to week 12
Glucose, insulin, glucagon, HbA1c. free fatty acids, Lipid profile (total-cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride). Inflammations markers (interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-1 receptor antagonist (IL-1RA), interleukin-1 beta (IL-1b), high sensitive c-reactive protein (hs-CRP), adiponectin, monocyte chemoattractant protein-1 (MCP-1), Rantes (CCL5)). Incretins (GLP-1, GIP). Nutrigenomics. Metabolomics. Proteomics.
Change from week 0 to week 12
Waist and hip circumference
Time Frame: Change from week 0 to week 12
Change from week 0 to week 12
Fat tissue biopsy
Time Frame: Change from week 0 to week 12
Fat tissue gene expression. Twice during meal test.
Change from week 0 to week 12
Biomarkers in urine
Time Frame: Change from week 0 to week 12
Nutrigenomics and metabolomics
Change from week 0 to week 12
Glucose tolerance
Time Frame: Change from week 0 to week 12
Oral glucose tolerance test (OGTT) (with insulin and glucose measurement at time -15 min, -10 min, 0 min, 30 min, 60 min, and 120 min). Hereby calculating the homeostatic model assessment of insulin resistance (HOMA-IR) and the Matsuda index.
Change from week 0 to week 12
Dietary compliance
Time Frame: Change from week 0 to week 12
3-day food diary.
Change from week 0 to week 12
Postprandial apolipoprotein-48 (apoB-48), 6 hour
Time Frame: Change from week 0 to week 12
Meal test, blood samples at time 0,2,4 and 6 hours.
Change from week 0 to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Wageningen University
University of Dublin, Trinity College
Arla Foods

Investigators

  • Study Chair: Hanne C Bertram, Scientist, Department of Food Science, University of Aarhus
  • Study Chair: Lorraine O'Driscoll, Professor, School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin, Ireland
  • Study Chair: Michael Müller, Professor, Division of Human Nutrition, Wageningen University, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (ESTIMATE)

November 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERN-DairyHealth

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Disease

Clinical Trials on High content of MC-SFA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe