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

Obesity Clinical Trial

— HEALTHGRAIN  

Official title:

Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869531
• Other study ID #: B223
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: March 25, 2009
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• wholegrain
wholegrain wheat vs. refined wheat products
• refined wheat
refined wheat products

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department og Human Nutrition	Frederiksberg C

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	BARILLA G. e R. Fratelli S.p.A., Parma, Italy, the European Commission in the Communities 6th Framework Programme, Project HEALTHGRAIN (FOOD-CT-2005-514008)

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight and composition		0, 6 and 12 wks	No
Secondary	Cardiovascular risk markers		0, 6 and 12 wks	No
Secondary	Fecal parameters		0 and 12 wks	No

External Links

•   EU project homepage