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

Not Applicable

Completed

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

• Registration Number: NCT01472666
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
24 hour blood pressure (BP)	Change from week 0 to week 12	Spacelabs, model 90207/90217, USA

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Aarhus C, Denmark