Status:
COMPLETED
Effects of a Wholegrain Diet on Body Composition and Energy Balance
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Société des Produits Nestlé (SPN)
Conditions:
Overweight
Obesity
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
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.
Detailed Description
The investigators hypothesis is that a diet high in whole-grains reduces abdominal fat. These findings might have clinical and public health significance for reducing obesity and related co-morbiditie...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01411540
Start Date
June 1 2010
End Date
December 1 2014
Last Update
January 10 2017
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195