Effect of Wholegrain Wheat on Body Weight and Composition and Cardiovascular Risk (HEALTHGRAIN)

University of Copenhagen

Status: Completed

Conditions: Obesity

Treatments: Other: wholegrain; Other: refined wheat

Study type: Interventional

Funder types: Other

Identifiers

NCT00869531

B223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

WW

Experimental group

Description:

wholegrain wheat

Treatment:

Other: wholegrain

RW

Active Comparator group

Description:

refined wheat

Treatment:

Other: refined wheat