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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT01472666

Collaborator

Aarhus University Hospital (Other), Arla Foods (Industry), Wageningen University (Other), University of Dublin, Trinity College (Other)

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Type 2 Diabetes Cardiovascular Disease Abdominal Obesity	Dietary Supplement: High content of MC-SFA Dietary Supplement: Whey Dietary Supplement: Low content of MC-SFA Dietary Supplement: Casein	N/A

Detailed Description

See above.

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Postprandial triglyceride response [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.

Secondary Outcome Measures

24 hour blood pressure (BP) [Change from week 0 to week 12]
Spacelabs, model 90207/90217, USA
Indirect calorimetry [Change from week 0 to week 12]
Measured 2 times during meal test.
Dexa-scan (body composition) [Change from week 0 to week 12]
Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight.
Weight [Change from week 0 to week 12]
Biomarkers in blood samples [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.
Waist and hip circumference [Change from week 0 to week 12]
Fat tissue biopsy [Change from week 0 to week 12]
Fat tissue gene expression. Twice during meal test.
Biomarkers in urine [Change from week 0 to week 12]
Nutrigenomics and metabolomics
Glucose tolerance [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.
Dietary compliance [Change from week 0 to week 12]
3-day food diary.
Postprandial apolipoprotein-48 (apoB-48), 6 hour [Change from week 0 to week 12]
Meal test, blood samples at time 0,2,4 and 6 hours.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus	Aarhus C	Denmark	8000

Sponsors and Collaborators

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

Investigators

Principal Investigator: Kjeld Hermansen, Professor, Aarhus University Hospital
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