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

Primary Purpose

Metabolic Syndrome, Type 2 Diabetes, Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High content of MC-SFA
Whey
Low content of MC-SFA
Casein
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Medium chain fatty acids, Saturated fatty acids, Whey protein, Casein protein, Metabolic syndrome, Type 2 diabetes, Cardiovascular disease, Dairy products, Dietary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Fat rich in MC-SFA

Fat low on MC-SFA

Casein protein

Whey protein

Arm Description

63 gram milk fat with high content of MC-SFA (C6-C12=8.5 g) incorporated in rolls, muffin and as butter.

63 gram milkfat with low content of MC-SFA (C6-C12=6.9 g) incorporated in rolls, muffin and as butter

60 gram casein protein (Miprodan 30) ingested twice daily with 600 ml water.

60 gram whey protein (Lacprodan DI-9224) ingested twice daily with 600 ml water.

Outcomes

Primary Outcome Measures

Postprandial triglyceride response
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)
Spacelabs, model 90207/90217, USA
Indirect calorimetry
Measured 2 times during meal test.
Dexa-scan (body composition)
Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight.
Weight
Biomarkers in blood samples
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
Fat tissue biopsy
Fat tissue gene expression. Twice during meal test.
Biomarkers in urine
Nutrigenomics and metabolomics
Glucose tolerance
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
3-day food diary.
Postprandial apolipoprotein-48 (apoB-48), 6 hour
Meal test, blood samples at time 0,2,4 and 6 hours.

Full Information

First Posted
November 1, 2011
Last Updated
February 29, 2016
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Arla Foods, Wageningen University, University of Dublin, Trinity College
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1. Study Identification

Unique Protocol Identification Number
NCT01472666
Brief Title
Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"
Official Title
Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Arla Foods, Wageningen University, University of Dublin, Trinity College

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
See above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Type 2 Diabetes, Cardiovascular Disease, Abdominal Obesity
Keywords
Medium chain fatty acids, Saturated fatty acids, Whey protein, Casein protein, Metabolic syndrome, Type 2 diabetes, Cardiovascular disease, Dairy products, Dietary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fat rich in MC-SFA
Arm Type
Experimental
Arm Description
63 gram milk fat with high content of MC-SFA (C6-C12=8.5 g) incorporated in rolls, muffin and as butter.
Arm Title
Fat low on MC-SFA
Arm Type
Experimental
Arm Description
63 gram milkfat with low content of MC-SFA (C6-C12=6.9 g) incorporated in rolls, muffin and as butter
Arm Title
Casein protein
Arm Type
Experimental
Arm Description
60 gram casein protein (Miprodan 30) ingested twice daily with 600 ml water.
Arm Title
Whey protein
Arm Type
Experimental
Arm Description
60 gram whey protein (Lacprodan DI-9224) ingested twice daily with 600 ml water.
Intervention Type
Dietary Supplement
Intervention Name(s)
High content of MC-SFA
Intervention Description
12 weeks dietary intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey
Intervention Description
12 weeks dietary intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Low content of MC-SFA
Intervention Description
12 weeks dietary intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Casein
Intervention Description
12 weeks dietary intervention
Primary Outcome Measure Information:
Title
Postprandial triglyceride response
Description
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.
Time Frame
Change from week 0 to week 12
Secondary Outcome Measure Information:
Title
24 hour blood pressure (BP)
Description
Spacelabs, model 90207/90217, USA
Time Frame
Change from week 0 to week 12
Title
Indirect calorimetry
Description
Measured 2 times during meal test.
Time Frame
Change from week 0 to week 12
Title
Dexa-scan (body composition)
Description
Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight.
Time Frame
Change from week 0 to week 12
Title
Weight
Time Frame
Change from week 0 to week 12
Title
Biomarkers in blood samples
Description
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.
Time Frame
Change from week 0 to week 12
Title
Waist and hip circumference
Time Frame
Change from week 0 to week 12
Title
Fat tissue biopsy
Description
Fat tissue gene expression. Twice during meal test.
Time Frame
Change from week 0 to week 12
Title
Biomarkers in urine
Description
Nutrigenomics and metabolomics
Time Frame
Change from week 0 to week 12
Title
Glucose tolerance
Description
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.
Time Frame
Change from week 0 to week 12
Title
Dietary compliance
Description
3-day food diary.
Time Frame
Change from week 0 to week 12
Title
Postprandial apolipoprotein-48 (apoB-48), 6 hour
Description
Meal test, blood samples at time 0,2,4 and 6 hours.
Time Frame
Change from week 0 to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Hermansen, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanne C Bertram, Scientist
Organizational Affiliation
Department of Food Science, University of Aarhus
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lorraine O'Driscoll, Professor
Organizational Affiliation
School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin, Ireland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Müller, Professor
Organizational Affiliation
Division of Human Nutrition, Wageningen University, The Netherlands
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data
Citations:
PubMed Identifier
25833983
Citation
Bohl M, Bjornshave A, Rasmussen KV, Schioldan AG, Amer B, Larsen MK, Dalsgaard TK, Holst JJ, Herrmann A, O'Neill S, O'Driscoll L, Afman L, Jensen E, Christensen MM, Gregersen S, Hermansen K. Dairy proteins, dairy lipids, and postprandial lipemia in persons with abdominal obesity (DairyHealth): a 12-wk, randomized, parallel-controlled, double-blinded, diet intervention study. Am J Clin Nutr. 2015 Apr;101(4):870-8. doi: 10.3945/ajcn.114.097923. Epub 2015 Jan 14.
Results Reference
derived

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

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