Effects of a Wholegrain Diet on Body Composition and Energy Balance

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
John Kirwan, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01411540
First received: July 27, 2011
Last updated: December 23, 2013
Last verified: December 2013

July 27, 2011
December 23, 2013
June 2010
December 2014   (final data collection date for primary outcome measure)
Change in body composition [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01411540 on ClinicalTrials.gov Archive Site
  • Total energy expenditure [ Time Frame: Eight-week cross-over trial with 10 week washout period between intervention arms. ] [ Designated as safety issue: No ]
    DLW will be used to assess total daily energy expenditure (TDEE).
  • Glucose turnover [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Glucose turnover will be assessed by [U-13C] glucose and [6,6-(2)H] glucose kinetics from breath, plasma and urine samples.
  • Protein turnover [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Protein turnover will be examined using 13C-leucine and 15N-glycine kinetics in breath, plamsa, and urine samples.
Same as current
Not Provided
Not Provided
 
Effects of a Wholegrain Diet on Body Composition and Energy Balance
Effects of Diet on Body Composition

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Overweight
  • Obesity
  • Pre-diabetic
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
  • 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.
    Intervention: Dietary Supplement: Whole grains
  • 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.
    Intervention: Dietary Supplement: Whole grains
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2014
December 2014   (final data collection date for primary outcome measure)

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)
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01411540
10-434
No
John Kirwan, The Cleveland Clinic
The Cleveland Clinic
Nestlé
Principal Investigator: John P. Kirwan, Ph.D. The Cleveland Clinic
The Cleveland Clinic
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP