NCT00869531CompletedNot Applicable
Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 85
- Locations
- 2
- Primary Endpoint
- Body weight and composition
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI 27-37
- •Postmenopausal (>1y) women
- •40-70 years old
Exclusion Criteria
- •Medication (hypertensive treatment not included)
- •BP > 160/100
- •Fasting glucose > 7mM
- •Fasting cholesterol > 6.5mM
- •Known chronic illnesses
Outcomes
Primary Outcomes
Body weight and composition
Time Frame: 0, 6 and 12 wks
Secondary Outcomes
- Cardiovascular risk markers(0, 6 and 12 wks)
- Fecal parameters(0 and 12 wks)
Investigators
Study Sites (2)
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