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OverweightNCT01411540

Effects of a Wholegrain Diet on Body Composition and Energy Balance

A study testing Whole grains in people with Overweight and Obesity, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity, Pre-diabetic
What is being tested?
Whole grains
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Jun 2010to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Whole grains
Keywords
Body composition, Health markers, Diet
Medical subject headings
Overweight, Obesity, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole grainsDietary supplement

    Also called Diet, Body composition

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

Study groups in NCT01411540
Study groupRoleWhat they receive
Whole grain dietExperimentalSubjects 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.
Receives: Dietary Supplement: Whole grains
Refined grain dietActive comparatorSubjects 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.
Receives: Dietary Supplement: Whole grains

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (3)

  1. Total energy expenditure

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

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

  2. Glucose turnover

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

    Measured: Eight weeks

  3. Protein turnover

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

    Measured: Eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01411540
Sponsor's protocol ID
10-434
Status last verified
Jan 2017
First submitted
27 Jul 2011
Last updated
10 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34805723

  • 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.

    PubMed 29305946

  • 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.

    PubMed 27798329

Questions about this trial

What is this clinical trial studying?

A study testing Whole grains in people with Overweight and Obesity, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body composition (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01411540, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.

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