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

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Arla Foods
Wageningen University
University of Dublin, Trinity College
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01472666
First received: November 1, 2011
Last updated: July 3, 2013
Last verified: July 2013

November 1, 2011
July 3, 2013
October 2011
December 2012   (final data collection date for primary outcome measure)
Postprandial triglyceride response [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
Compare the changes in mean difference of 6 hours iAUC (week 12 - week 0) between the groups and the intervention components.
Postprandial triglyceride response [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
Compare the mean difference in 6 hours AUC (week 12 - week 0) between the two groups
Complete list of historical versions of study NCT01472666 on ClinicalTrials.gov Archive Site
  • 24 hour blood pressure [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
    Spacelabs, model 90207/90217, USA
  • Indirect calorimetry [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
    Measured 2 times during meal test.
  • Dexa-scan (body composition) [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
    Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight.
  • Weight [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
  • Biomarkers in blood samples [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
    Glucose, insulin, glucagon, HbA1c. NEFA, Lipid profile (total-cholesterol, LDL, HDL, triglyceride). Inflammations markers (IL-6, Il-10, IL-1RA, IL-1b, hs-CRP, adiponectin, MCP-1, Rantes/CCL5). Incretins (GLP-1, GIP). Nutrigenomic. Metabolomics. Proteonomics.
  • Waist and hip circumference [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
  • Fat tissue biopsy [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
    Fat tissue gene expression. Twice during meal test.
  • Biomarkers in urine [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
    Nutrigenomic and metabolomics
  • Glucose tolerance [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
    OGTT (with insulin and glucose measurement at time -15 min, -10 min, 0 min, 30 min, 60 min, and 120 min). Hereby calculating HOMA-IR and Matsuda index.
  • Dietary compliance [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
    3-day food diary. Measuring of C15:0 and C17:0 in blood.
  • Postprandial ApoB-48, 6 hour [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]
    Meal test, blood samples at time 0,2,4 and 6 hours.
  • 24 hour blood pressure [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
    Spacelabs, model 90207/90217, USA
  • Indirect calorimetry [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
    Measured 3 times during meal test.
  • Dexa-scan (body composition) [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
  • Biomarkers in blood samples [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
    Glucose, insulin, glucagon, HbA1c. NEFA, Lipid profile (total-cholesterol, LDL, HDL, triglyceride). Inflammations markers (IL-6, hs-CRP, PAI-1, adiponectin, MCP-1, Rantes/CCL5). Incretins (GLP-1, GIP). Nutrigenomic. Metabolomics. Proteonomics.
  • Waist and hip circumference [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
  • Fat tissue biopsy [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
    Fat tissue genexpression. Twice during meal test.
  • Biomarkers in urine [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
    Nutrigenomic and metabolomics
  • Glucose tolerance [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
    OGTT. HOMA and Matsuda.
  • Dietary compliance [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
    3-day food diary. Measuring of C15:0 and C17:0 in blood.
  • Postprandial ApoB-48, 6 hour [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
    Meal test, blodsamples at time 0,2,4 and 6 hours.
Not Provided
Not Provided
 
Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"
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 short- and medium-chain saturated fatty acids (SMC-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 short- and 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 short- 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 SMC-SFA + whey protein (LF + whey), a diet high in SMC-SFA + whey protein (HF + whey), a diet high in SMC-SFA + casein protein (HF + casein) or a diets with low levels of SMC-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.

See above.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Type 2 Diabetes
  • Cardiovascular Disease
  • Abdominal Obesity
  • Dietary Supplement: High content of SMC-SFA
    12 weeks dietary intervention
  • Dietary Supplement: Whey
    12 weeks dietary intervention
  • Dietary Supplement: Low content of SMC-SFA
    12 weeks dietary intervention
  • Dietary Supplement: Casein
    12 weeks dietary intervention
  • Experimental: Fat rich in SMC-SFA
    63 gram milk fat with high content of SMC-SFA (C4-C14=21.01 g. C6-C14=16.91g) incorporated in rolls, muffin and as butter.
    Intervention: Dietary Supplement: High content of SMC-SFA
  • Experimental: Fat low on SMC-SFA
    63 gram milkfat with low content of SMC-SFA (C4-C14=18.79 g. C6-C14=14.13 g) incorporated in rolls, muffin and as butter
    Intervention: Dietary Supplement: Low content of SMC-SFA
  • Experimental: Casein protein
    60 gram casein protein (Miprodan 30) ingested twice daily with 600 ml water.
    Intervention: Dietary Supplement: Casein
  • Experimental: Whey protein
    60 gram whey protein (Lacprodan DI-9224) ingested twice daily with 600 ml water.
    Intervention: Dietary Supplement: Whey
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
December 2012
December 2012   (final data collection date for primary outcome measure)

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
  • BT ≥ 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01472666
CERN-DairyHealth
No
University of Aarhus
University of Aarhus
  • Aarhus University Hospital
  • Arla Foods
  • Wageningen University
  • University of Dublin, Trinity College
Principal Investigator: Kjeld Hermansen, Professor Aarhus University Hospital
Study Chair: Hanne C Bertram, Sen. 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
University of Aarhus
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP