Effect of Wholegrain Wheat on Body Weight and Composition and Cardiovascular Risk

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: wholegrain; Other: refined wheat

• Registration Number: NCT00869531
• Lead Sponsor: University of Copenhagen

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 Timeline

• Study Start: 2007-08
• Primary Completion: 2008-02
• Study Completion: 2008-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Last Update Submitted: 2009-03-25
• Study First Posted: 2009-03-26
• Last Update Posted: 2009-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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
• Smoking
• Known chronic illnesses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WW	wholegrain	wholegrain wheat
RW	refined wheat	refined wheat

Primary Outcome Measures

Name	Time	Method
Body weight and composition	0, 6 and 12 wks

Secondary Outcome Measures

Name	Time	Method
Cardiovascular risk markers	0, 6 and 12 wks
Fecal parameters	0 and 12 wks

Trial Locations

Locations (1)

University of Copenhagen, Department og Human Nutrition; 🇩🇰 Frederiksberg C, Denmark