Effects of a Wholegrain Diet on Body Composition and Energy Balance

Completed · Not applicable

Conditions studied: Overweight, Obesity, Pre-diabetic

In brief

The purpose of this study is to compare a diet containing whole grains versus an energy matched diet using refined grains on body composition and metabolism.

Key facts

Study ID

NCT01411540

Run by

The Cleveland Clinic

People needed

35

Starts

2010-06-01

Expected to finish

2014-12-01

Last updated by the study team

2017-01-10

Who can join

Age: 20 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged between 20-50 years
• BMI between 25 and 38 kg/m2
• Normal whole grain intake <1 serving/d (Appendix 1)
• Low average consumption of alcohol (<1 standard drink/day; <7 standard drinks/week)
• Non-smoker
• No major chronic illness
• Fasting glucose <126 mg/dl
• Able to access the study centre (Lerner Research Institute and the Clinical Research Unit at the Cleveland Clinic) throughout the study
• Have access to a microwave oven and refrigerator/freezer

You may not qualify if…

• Any known food allergy with the possibility to result in a serious adverse reaction, or an allergy to a food item that cannot be removed from the diet (i.e. peanuts).
• Aversion or dislike to study foods
• Regular use of dietary supplements and not willing/able to stop usage during the study period
• Cardiovascular conditions including significant known coronary artery disease, arrhythmia, known peripheral vascular disease (large vessel disease), uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension (defined as medically treated with the mean of 3 separate measurements SBP > 180 mm Hg or DBP > 110 mm Hg)
• Severe pulmonary disease defined as FEV1 < 50% of predicted value
• Kidney disease including diagnosed chronic kidney disease, renovascular hypertension, renal artery stenosis, or chronic renal insufficiency with a creatinine level > 1.8 mg/dl
• Known history of chronic liver disease (except for NAFLD), hepatitis, positive serologic test result for hepatitis B surface antigen and/or hepatitis C antibody, α-1-antitrypsin deficiency
• GI disorders including a known history of celiac disease and/or any other malabsorptive disorders or inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• Psychiatric disorders including dementia, active psychosis, severe depression (requiring > 2 medications), history of suicide attempts, alcohol or drug abuse within the previous 12 months
• Other known metabolic disease such as clinical hypothyroidism and hyper thyroidism, Graves Disease, thyroid cancer, nodules or multinodular goiter
• Malignancy within five years (except squamous cell and basal cell cancer of the skin)

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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