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Completed

NCT Number: NCT01472666

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

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.

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Key information

About this study

See above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High content of MC-SFA

Dietary Supplement

12 weeks dietary intervention

Whey

Dietary Supplement

12 weeks dietary intervention

Low content of MC-SFA

Dietary Supplement

12 weeks dietary intervention

Casein

Dietary Supplement

12 weeks dietary intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 24 hour blood pressure (BP)

    Time frame: Change from week 0 to week 12

    Spacelabs, model 90207/90217, USA

  2. Indirect calorimetry

    Time frame: Change from week 0 to week 12

    Measured 2 times during meal test.

  3. 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.

  4. Weight

    Time frame: Change from week 0 to week 12

  5. 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.

  6. Waist and hip circumference

    Time frame: Change from week 0 to week 12

  7. Fat tissue biopsy

    Time frame: Change from week 0 to week 12

    Fat tissue gene expression. Twice during meal test.

  8. Biomarkers in urine

    Time frame: Change from week 0 to week 12

    Nutrigenomics and metabolomics

  9. 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.

  10. Dietary compliance

    Time frame: Change from week 0 to week 12

    3-day food diary.

  11. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2011
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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