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
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Type 2 Diabetes
Cardiovascular Disease
Abdominal Obesity
Dietary Supplement: High content of SMC-SFA
Dietary Supplement: Whey
Dietary Supplement: Low content of SMC-SFA
Dietary Supplement: Casein

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 63
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: High content of SMC-SFA
12 weeks dietary intervention
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
Dietary Supplement: Low content of SMC-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

Detailed Description:

See above.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472666

Locations
Denmark
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, 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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01472666     History of Changes
Other Study ID Numbers: CERN-DairyHealth
Study First Received: November 1, 2011
Last Updated: July 3, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Short chain fatty acids
Medium chain fatty acids
Saturated fatty acids
Whey protein
Casein protein
Metabolic syndrome
Type 2 diabetes
Cardiovascular disease
Dairy products
Dietary intervention

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Obesity, Abdominal
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014