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Grains Reduce Adiposity and Improve Nutrition Study

NCT00924521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-08-21

No results posted yet for this study

Summary

Whole grain intake beneficially affects body weight, body fat and glucose metabolism, and the investigators' previous work has shown that a high whole grain intake significantly reduced body fat in the abdominal region as measured by dual energy X-ray absorptiometry (DEXA) compared to a refined grain intake. Additional research is needed with regard to the mechanisms by which whole grains may affect visceral adiposity and the adipokines, which have been associated with risk for insulin resistance and type 2 diabetes. Therefore the proposed study aims to address these issues and in addition, includes exploratory work with adipocytes in cell culture to evaluate the effects of whole grains on adipocyte function.

Hypothesis:

There will be a greater reduction in visceral adiposity, indicators of insulin resistance (HOMA score), improvement in inflammatory status and improvement in adipokine levels after six weeks of a weight stable period and after six weeks of weight loss in subjects consuming 6-9 servings compared to 0 servings of whole grains per day.

Conditions

Interventions

DIETARY_SUPPLEMENT

Whole grain diet

Participants in this group will receive 6-9 servings of whole grain daily to replace the refined grains typically included in the average American diet. Number of servings will depend upon calorie assignment.

DIETARY_SUPPLEMENT

Refined grain

Participants in this group will receive only refined grains as typically consumed in the average American diet.

Sponsors & Collaborators

  • General Mills

    collaborator INDUSTRY

  • Penn State University

    lead OTHER

Principal Investigators

  • Penny M Kris-Etherton, PhD · Penn State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-04-30
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00924521 on ClinicalTrials.gov