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

October 21, 2013 updated by: Icahn School of Medicine at Mount Sinai

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole grain rice
Other: Whole grain rice
Whole grain rice arm (treatment arm): Subjects will be provided a supply of whole grain rice and will be asked to prepare rice items in their meal with the provided whole grain rice while participating in the study
Active Comparator: Refined grain rice
Other: Refined grain rice
Refined grain rice arm (control arm): Subjects will be provided a supply of refined grain rice and will be asked to prepare rice items in their meal with the provided refined grain rice while participating in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homeostatic Model Assessment (HOMA) Index
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Homeostatic model assessment(HOMA) index
Time Frame: 6 weeks
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
6 weeks
Homeostatic model assessment (HOMA) index.
Time Frame: 12 weeks
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carboxymethyl lysine (CML)
Time Frame: 0, 6 and 12 weeks
Advanced glycation end product (in blood and urine)
0, 6 and 12 weeks
Methylglyoxal (MG)
Time Frame: 0, 6 and 12 weeks
Advanced glycation end product (in blood and urine)
0, 6 and 12 weeks
IL-6
Time Frame: 0, 6 and 12 weeks
Inflammatory marker
0, 6 and 12 weeks
Receptor for advanced glycation endproducts (RAGE)
Time Frame: 0, 6 and 12 weeks
Receptor for advanced glycation endproducts
0, 6 and 12 weeks
Sirtuin 1
Time Frame: 0, 6 and 12 weeks
A protein that in humans is encoded by the SIRT1 gene and regulates processes such as apoptosis and muscle differentiation by deacetylating key proteins. It is down regulated in cells that have high insulin resistance and inducing its expression increases insulin sensitivity
0, 6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

November 17, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

October 22, 2013

Last Update Submitted That Met QC Criteria

October 21, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 10-0924
  • 10-0924 0001 01 ME (Other Identifier: Mount Sinai Grants and Contract Office)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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