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

NCT01472666 | Completed

• 1 other identifier: CERN-DairyHealth
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 24 hour blood pressure (BP)

  Change from week 0 to week 12

• Indirect calorimetry

  Change from week 0 to week 12

• Dexa-scan (body composition)

  Change from week 0 to week 12

• Weight

  Change from week 0 to week 12

• Biomarkers in blood samples

  Change from week 0 to week 12

Study Arms (4)

Fat rich in MC-SFA

EXPERIMENTAL

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

Dietary Supplement: High content of MC-SFA

Fat low on MC-SFA

EXPERIMENTAL

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

Dietary Supplement: Low content of MC-SFA

Casein protein

EXPERIMENTAL

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

Dietary Supplement: Casein

Whey protein

EXPERIMENTAL

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

Dietary Supplement: Whey

Interventions

High content of MC-SFA DIETARY_SUPPLEMENT

12 weeks dietary intervention

Fat rich in MC-SFA

Whey DIETARY_SUPPLEMENT

12 weeks dietary intervention

Whey protein

Low content of MC-SFA DIETARY_SUPPLEMENT

12 weeks dietary intervention

Fat low on MC-SFA

Casein DIETARY_SUPPLEMENT

12 weeks dietary intervention

Casein protein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Significant cardiovascular, renal or endocrine disease
• Psychiatric history
• Treatment with steroids
• Alcohol- or drug-addiction
• Pregnancy or lactation

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Arla Foods: collaborator
• Wageningen University: collaborator
• University of Dublin, Trinity College: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus C, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 25833983 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Obesity, Abdominal

Interventions

Whey; Caseins

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins

Study Officials

• Kjeld Hermansen, Professor

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Hanne C Bertram, 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 16, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 1, 2016

Record last verified: 2013-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)