Grains Reduce Adiposity and Improve Nutrition Study

Completed · Not applicable

Conditions studied: Metabolic Syndrome, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT00924521

Run by

Penn State University

People needed

54

Starts

2009-03-01

Expected to finish

2011-08-01

Last updated by the study team

2023-08-21

Who can join

Age: 35 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI > 25 to < 42
• Waist circumference of > 40 inches for males and > 35 inches for females and having one other of the criteria for metabolic syndrome will be recruited
• In this population, we will also accept the following:
• LDL-C < 175 mg/dL
• HDL-C > 25 mg/dL
• Triglycerides < 400 mg/dL
• All subjects will be required to meet one specific criteria for metabolic syndrome beyond increased waist circumference

You may not qualify if…

• Smokers
• Have insulin-dependent diabetes
• Are pregnant or expecting to be pregnant, lactating in the last 6 months
• Are taking NSAIDS or other medications known to affect inflammatory markers or drugs affecting glucose metabolism
• Blood pressure lowering medications are acceptable if the person has controlled BP at screening, <140/90 mmHg.

Where it is running

• Penn State University — University Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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