Status:

COMPLETED

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

Lead Sponsor:

Icahn School of Medicine at Mount Sinai

Conditions:

Diabetes

Prediabetes

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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, ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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).

Key Trial Info

Start Date :

November 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2011

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT01248286

Start Date

November 1 2010

End Date

April 1 2011

Last Update

October 22 2013

Active Locations (1)

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Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029