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NCT Number: NCT01248286

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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).

Treatment and study plan

Whole grain rice

Other

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

Refined grain rice

Other

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

Primary outcomes

  1. Homeostatic Model Assessment (HOMA) Index

    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels

  2. Homeostatic model assessment(HOMA) index

    Time frame: 6 weeks

    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels

  3. Homeostatic model assessment (HOMA) index.

    Time frame: 12 weeks

    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels

Secondary outcomes

  1. Carboxymethyl lysine (CML)

    Time frame: 0, 6 and 12 weeks

    Advanced glycation end product (in blood and urine)

  2. Methylglyoxal (MG)

    Time frame: 0, 6 and 12 weeks

    Advanced glycation end product (in blood and urine)

  3. IL-6

    Time frame: 0, 6 and 12 weeks

    Inflammatory marker

  4. Receptor for advanced glycation endproducts (RAGE)

    Time frame: 0, 6 and 12 weeks

    Receptor for advanced glycation endproducts

  5. 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2010
Registry last updated
Oct 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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