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Effects of a Wholegrain Diet on Body Composition and Energy Balance

Primary Purpose

Overweight, Obesity, Pre-diabetic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Whole grains

About this trial

This is an interventional treatment trial for Overweight focused on measuring Body composition, Health markers, Diet

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Whole grain diet

Refined grain diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in body composition

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

Total energy expenditure

DLW will be used to assess total daily energy expenditure (TDEE).

Glucose turnover

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

Protein turnover

Protein turnover will be examined using 13C-leucine and 15N-glycine kinetics in breath, plamsa, and urine samples.

Full Information

NCT ID

NCT01411540

First Posted

July 27, 2011

Last Updated

January 6, 2017

Sponsor

The Cleveland Clinic

Collaborators

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT01411540

Brief Title

Effects of a Wholegrain Diet on Body Composition and Energy Balance

Official Title

Effects of Diet on Body Composition

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Cleveland Clinic

Collaborators

Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee

5. Study Description

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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity, Pre-diabetic

Keywords

Body composition, Health markers, Diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Whole grain diet

Arm Type

Experimental

Arm Description

Arm Title

Refined grain diet

Arm Type

Active Comparator

Arm Description

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 Type

Dietary Supplement

Intervention Name(s)

Whole grains

Other Intervention Name(s)

Diet, Body composition

Intervention Description

Comparison of a diet containing whole grain compared to an energy matched diet based on similar foods, but using refined grains.

Primary Outcome Measure Information:

Title

Change in body composition

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Total energy expenditure

Description

DLW will be used to assess total daily energy expenditure (TDEE).

Time Frame

Eight-week cross-over trial with 10 week washout period between intervention arms.

Title

Glucose turnover

Description

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

Time Frame

Eight weeks

Title

Protein turnover

Description

Protein turnover will be examined using 13C-leucine and 15N-glycine kinetics in breath, plamsa, and urine samples.

Time Frame

Eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P. Kirwan, Ph.D.

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34805723

Citation

Mey JT, Godin JP, Scelsi AR, Kullman EL, Malin SK, Yang S, Floyd ZE, Poulev A, Fielding RA, Ross AB, Kirwan JP. A Whole-Grain Diet Increases Whole-Body Protein Balance Compared with a Macronutrient-Matched Refined-Grain Diet. Curr Dev Nutr. 2021 Sep 25;5(11):nzab121. doi: 10.1093/cdn/nzab121. eCollection 2021 Nov.

Results Reference

derived

PubMed Identifier

29305946

Citation

Malin SK, Kullman EL, Scelsi AR, Haus JM, Filion J, Pagadala MR, Godin JP, Kochhar S, Ross AB, Kirwan JP. A whole-grain diet reduces peripheral insulin resistance and improves glucose kinetics in obese adults: A randomized-controlled trial. Metabolism. 2018 May;82:111-117. doi: 10.1016/j.metabol.2017.12.011. Epub 2018 Jan 3.

Results Reference

derived

PubMed Identifier

27798329

Citation

Kirwan JP, Malin SK, Scelsi AR, Kullman EL, Navaneethan SD, Pagadala MR, Haus JM, Filion J, Godin JP, Kochhar S, Ross AB. A Whole-Grain Diet Reduces Cardiovascular Risk Factors in Overweight and Obese Adults: A Randomized Controlled Trial. J Nutr. 2016 Nov;146(11):2244-2251. doi: 10.3945/jn.116.230508. Epub 2016 Oct 19.

Results Reference

derived

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Effects of a Wholegrain Diet on Body Composition and Energy Balance

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