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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01248286
First received: November 17, 2010
Last updated: October 21, 2013
Last verified: October 2013

November 17, 2010
October 21, 2013
November 2010
April 2011   (final data collection date for primary outcome measure)
  • Homeostatic Model Assessment (HOMA) Index [ Time Frame: 0 ] [ Designated as safety issue: No ]
    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
  • Homeostatic model assessment(HOMA) index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
  • Homeostatic model assessment (HOMA) index. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Same as current
Complete list of historical versions of study NCT01248286 on ClinicalTrials.gov Archive Site
  • Carboxymethyl lysine (CML) [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Advanced glycation end product (in blood and urine)
  • Methylglyoxal (MG) [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Advanced glycation end product (in blood and urine)
  • IL-6 [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Inflammatory marker
  • Receptor for advanced glycation endproducts (RAGE) [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Receptor for advanced glycation endproducts
  • Sirtuin 1 [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diabetes
  • Prediabetes
  • 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
  • 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
  • Experimental: Whole grain rice
    Intervention: Other: Whole grain rice
  • Active Comparator: Refined grain rice
    Intervention: Other: Refined grain rice

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2011
April 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01248286
GCO 10-0924, 10-0924 0001 01 ME
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Jaime Uribarri, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP