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Completed

NCT Number: NCT00869531

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

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Department og Human Nutrition

Frederiksberg C, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wholegrain

Other

wholegrain wheat vs. refined wheat products

refined wheat

Other

refined wheat products

Primary outcomes

  1. Body weight and composition

    Time frame: 0, 6 and 12 wks

Secondary outcomes

  1. Cardiovascular risk markers

    Time frame: 0, 6 and 12 wks

  2. Fecal parameters

    Time frame: 0 and 12 wks

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • BARILLA G. e R. Fratelli S.p.A., Parma, Italy
  • European Commission

Registry information

Official study title

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

Acronym: HEALTHGRAIN

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 26, 2009
Registry last updated
Mar 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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