Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes

Completed · Not applicable

Conditions studied: Diabetes, Prediabetes

In brief

Food products derived from cereal grains constitute a major part of the daily diet of many Americans . For example, a typical Chinese American eats rice about 9.5 times a week on an average. However, most of these foods are derived from refined grain. During the refining process grains are stripped of their bran and germ which results in depletion of several biologically active constituents including fiber, anti-oxidants, phytoestrogens and minerals. From observational studies there is evidence for a protective effect of whole-grain foods with regard to the development of type 2 diabetes. More recently, higher intake of whole grains was also associated with decreases in insulin resistance - a risk factor related to the development of type 2 diabetes. In this randomized study the investigators plan to replicate this beneficial effect of improving insulin sensitivity in patients with pre-diabetes and go a step further by exploring the potential mechanisms by which this benefit may occur. The investigators will assess the effect of consuming a whole-grain-rich diet on levels of advanced glycation endproducts (AGE), RAGE (receptor for AGE) and markers of inflammation and oxidative stress - all of which have been shown to play an important role in the pathogenesis of diabetes mellitus. The investigators will also look for correlations between the levels of these markers with insulin sensitivity to identify potential mechanisms of pathogenesis.

Key facts

Study ID

NCT01248286

Run by

Icahn School of Medicine at Mount Sinai

People needed

100

Starts

2010-11-01

Expected to finish

2011-04-01

Last updated by the study team

2013-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years to unlimited, both genders.
• At least one meal per day included rice in the seven days prior to enrolment.
• No current diagnosis of Diabetes Mellitus (DM).
• Fasting blood glucose value between 100 to 125 mg/dl and/or Hemoglobin A1c levels between 5.7%-6.4%.
• ≥ 2 visits with primary care physician to establish compliance

You may not qualify if…

• Special diets (e.g. vegetarian)
• Use of medications that would affect blood sugar levels (e.g. steroids)
• Allergy to any type of grain
• Body weight fluctuation over the past 180 days of ≥ 10%
• Planning to significantly change level of physical activity during the time of study.
• Planning to move out of town or take a vacation for ≥ 14 days during the time of the study
• Current smoker
• Consumption of greater than 2 alcoholic drinks per day
• History of malignancy and overt cardiovascular disease (apart from hypertension).

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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