Clinical trial NCT01472666: Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"
Official title: Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Arla Foods
name: Wageningen University
name: University of Dublin, Trinity College
First posted: 2011-11-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postprandial triglyceride response
timeFrame: Change from week 0 to week 12
Secondary outcomes:
measure: 24 hour blood pressure (BP)
timeFrame: Change from week 0 to week 12
measure: Indirect calorimetry
timeFrame: Change from week 0 to week 12
measure: Dexa-scan (body composition)
timeFrame: Change from week 0 to week 12
measure: Weight
timeFrame: Change from week 0 to week 12
measure: Biomarkers in blood samples
timeFrame: Change from week 0 to week 12
measure: Waist and hip circumference
timeFrame: Change from week 0 to week 12
measure: Fat tissue biopsy
timeFrame: Change from week 0 to week 12
measure: Biomarkers in urine
timeFrame: Change from week 0 to week 12
measure: Glucose tolerance
timeFrame: Change from week 0 to week 12
measure: Dietary compliance
timeFrame: Change from week 0 to week 12
measure: Postprandial apolipoprotein-48 (apoB-48), 6 hour
timeFrame: Change from week 0 to week 12
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Aarhus C
Study officials:
affiliation: Aarhus University Hospital
name: Kjeld Hermansen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Food Science, University of Aarhus
name: Hanne C Bertram, Scientist
role: STUDY_CHAIR
affiliation: School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin, Ireland
name: Lorraine O'Driscoll, Professor
role: STUDY_CHAIR
affiliation: Division of Human Nutrition, Wageningen University, The Netherlands
name: Michael Müller, Professor
role: STUDY_CHAIR
References:
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.