Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT01248286
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10029, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Time frame: 6 weeks
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Time frame: 12 weeks
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Time frame: 0, 6 and 12 weeks
Advanced glycation end product (in blood and urine)
Time frame: 0, 6 and 12 weeks
Advanced glycation end product (in blood and urine)
Time frame: 0, 6 and 12 weeks
Inflammatory marker
Time frame: 0, 6 and 12 weeks
Receptor for advanced glycation endproducts
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
Icahn School of Medicine at Mount Sinai
Other
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