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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472666
• Other study ID #: CERN-DairyHealth
• Status: Completed
• Phase: N/A
• First received: November 1, 2011
• Last updated: February 29, 2016
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

See above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity, Abdominal
• Syndrome
• Type 2 Diabetes

Intervention

Dietary Supplement:
• High content of MC-SFA
12 weeks dietary intervention
• Whey
12 weeks dietary intervention
• Low content of MC-SFA
12 weeks dietary intervention
• Casein
12 weeks dietary intervention

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Aarhus C

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Arla Foods, University of Dublin, Trinity College, Wageningen University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from week 0 to week 12	No
Secondary	24 hour blood pressure (BP)	Spacelabs, model 90207/90217, USA	Change from week 0 to week 12	No
Secondary	Indirect calorimetry	Measured 2 times during meal test.	Change from week 0 to week 12	No
Secondary	Dexa-scan (body composition)	Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight.	Change from week 0 to week 12	No
Secondary	Weight		Change from week 0 to week 12	No
Secondary	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.	Change from week 0 to week 12	No
Secondary	Waist and hip circumference		Change from week 0 to week 12	No
Secondary	Fat tissue biopsy	Fat tissue gene expression. Twice during meal test.	Change from week 0 to week 12	No
Secondary	Biomarkers in urine	Nutrigenomics and metabolomics	Change from week 0 to week 12	No
Secondary	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.	Change from week 0 to week 12	No
Secondary	Dietary compliance	3-day food diary.	Change from week 0 to week 12	No
Secondary	Postprandial apolipoprotein-48 (apoB-48), 6 hour	Meal test, blood samples at time 0,2,4 and 6 hours.	Change from week 0 to week 12	No