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

Mount Sinai Health System

Status: Completed

Conditions: Prediabetes; Diabetes

Treatments: Other: Whole grain rice; Other: Refined grain rice

Study type: Interventional

Funder types: Other

Identifiers

NCT01248286

10-0924 0001 01 ME (Other Identifier)

GCO 10-0924

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years to unlimited, both genders.
2. At least one meal per day included rice in the seven days prior to enrolment.
3. No current diagnosis of Diabetes Mellitus (DM).
4. Fasting blood glucose value between 100 to 125 mg/dl and/or Hemoglobin A1c levels between 5.7%-6.4%.
5. ≥ 2 visits with primary care physician to establish compliance

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Whole grain rice

Experimental group

Treatment:

Other: Whole grain rice

Refined grain rice

Active Comparator group

Treatment:

Other: Refined grain rice