Effect of Wholegrain Wheat on Body Weight and Composition and Cardiovascular Risk (HEALTHGRAIN)
The aim of this study is to investigate the potential beneficial effect of wholegrain on body weight and composition as well as cardiovascular risk in overweight women.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects|
- Body weight and composition [ Time Frame: 0, 6 and 12 wks ] [ Designated as safety issue: No ]
- Cardiovascular risk markers [ Time Frame: 0, 6 and 12 wks ] [ Designated as safety issue: No ]
- Fecal parameters [ Time Frame: 0 and 12 wks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
wholegrain wheat vs. refined wheat products
Active Comparator: RW
Other: refined wheat
refined wheat products
Objective: To study the effect of the 'wholegrain concept', i.e. high intake of wheat wholegrain (WW) vs. refined wheat (RW) grain products on body weight and composition.
Design: In this open-labeled randomized trial, 72 postmenopausal women with metabolic syndrome features were prescribed a mild calorie-restricted diet with a deficit of ~1,250kJ/d. Following 2 weeks run-in period on RW products, they were randomized to 12 weeks intervention with RW or WW products providing 2,000kJ/d.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869531
|University of Copenhagen, Department og Human Nutrition|
|Frederiksberg C, Denmark, 1958|