NCT01411540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

4.5 years

First QC Date

July 27, 2011

Last Update Submit

January 6, 2017

Conditions

OverweightObesityPre-diabetic

Keywords

Body compositionHealth markersDiet

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 months

Secondary Outcomes (3)

  • Total energy expenditure

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

  • Glucose turnover

    Eight weeks

  • Protein turnover

    Eight weeks

Study Arms (2)

Whole grain diet

EXPERIMENTAL

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

Refined grain diet

ACTIVE COMPARATOR

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

Interventions

Whole grainsDIETARY_SUPPLEMENT

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

Also known as: Diet, Body composition
Refined grain dietWhole grain diet

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

  • 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.

    PMID: 34805723DERIVED

  • 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.

    PMID: 29305946DERIVED

  • 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.

    PMID: 27798329DERIVED

MeSH Terms

Conditions

OverweightObesityGlucose Intolerance

Interventions

Whole GrainsDietBody Composition

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Edible GrainCrops, AgriculturalFoodDiet, Food, and NutritionPhysiological PhenomenaSeedsFood and BeveragesNutritional Physiological PhenomenaBiochemical PhenomenaChemical PhenomenaMetabolismBody Constitution

Study Officials

  • John P. Kirwan, Ph.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff, Department of Pathobiology

Study Record Dates

First Submitted

July 27, 2011

First Posted

August 8, 2011

Study Start

June 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

US(1)