Effects of a Wholegrain Diet on Body Composition and Energy Balance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01411540
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : January 10, 2017
Information provided by (Responsible Party):
John Kirwan, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Pre-diabetic Dietary Supplement: Whole grains Not Applicable

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-morbidities like type 2 diabetes and cardiovascular disease. Using a double-blind cross-over design, energy expenditure, body composition and metabolic health will be assessed. Three day inpatient study visits to the Cleveland Clinic Clinical Research Unit (CRU) will be implemented for metabolic control and testing. Total daily energy expenditure will be measured using the doubly labeled water (DLW) method. Body fat and glucose/protein metabolism will be assessed by imaging and isotope techniques, respectively. Blood, urine, and stool samples will also be collected for cardiometabolic and digestive health outcomes. After baseline testing, subjects will begin an 8 week dietary intervention, where all food and non-water beverages will be supplied by the study center. Dietary compliance will be assessed by weigh back measurements two times a week. To assess time course effects of diets differing in the amount of fiber on body composition and metabolic health, subjects will provide plasma and urine samples 2, 4, and 8 weeks after initial testing. Imaging and isotope analysis will be performed baseline and at week 8. All post testing will be conducted after week 8 following similar pre-testing control conditions. Subjects will then undergo an 8-10 week washout period where they will be instructed to return to their normal diet (except for any supplements). After the washout period, subjects will start the second arm of the intervention and consume the alternate diet (i.e. refined or whole grain diet). All energy expenditure, body composition and metabolic testing procedures will be repeated during the alternative arm of the study as described above.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Diet on Body Composition
Study Start Date : June 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Whole grain diet
Subjects will eat a whole grain based diet for eight weeks. Pre-and post-diet intervention testing will determine effects on body composition. Whole grain-based are will be compared to the refined grain based diet.
Dietary Supplement: Whole grains
Comparison of a diet containing whole grain compared to an energy matched diet based on similar foods, but using refined grains.
Other Names:
  • Diet
  • Body composition

Active Comparator: Refined grain diet
Subjects will eat a refined grain diet for 8 weeks matched with the whole grain arm for calorie and macro nutrient intake. Pre-and post-diet testing will determine effects on body composition.
Dietary Supplement: Whole grains
Comparison of a diet containing whole grain compared to an energy matched diet based on similar foods, but using refined grains.
Other Names:
  • Diet
  • Body composition

Primary Outcome Measures :
  1. Change in body composition [ Time Frame: 24 months ]
    The primary outcome is the change in body composition after an eight-week intervention of either whole grains or refined grains, corrected for baseline body composition at the start of the appropriate treatment arm.

Secondary Outcome Measures :
  1. Total energy expenditure [ Time Frame: Eight-week cross-over trial with 10 week washout period between intervention arms. ]
    DLW will be used to assess total daily energy expenditure (TDEE).

  2. Glucose turnover [ Time Frame: Eight weeks ]
    Glucose turnover will be assessed by [U-13C] glucose and [6,6-(2)H] glucose kinetics from breath, plasma and urine samples.

  3. Protein turnover [ Time Frame: Eight weeks ]
    Protein turnover will be examined using 13C-leucine and 15N-glycine kinetics in breath, plamsa, and urine samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01411540

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: John P. Kirwan, Ph.D. The Cleveland Clinic

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: John Kirwan, Staff, Department of Pathobiology, The Cleveland Clinic Identifier: NCT01411540     History of Changes
Other Study ID Numbers: 10-434
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by John Kirwan, The Cleveland Clinic:
Body composition
Health markers

Additional relevant MeSH terms:
Prediabetic State
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases