Trials / Completed
CompletedNCT01472666
Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- University of Aarhus · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | High content of MC-SFA | 12 weeks dietary intervention |
| DIETARY_SUPPLEMENT | Whey | 12 weeks dietary intervention |
| DIETARY_SUPPLEMENT | Low content of MC-SFA | 12 weeks dietary intervention |
| DIETARY_SUPPLEMENT | Casein | 12 weeks dietary intervention |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2011-11-16
- Last updated
- 2016-03-01
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01472666. Inclusion in this directory is not an endorsement.