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| ID | Type | Description | Link |
|---|---|---|---|
| 10-0924 0001 01 ME | Other Identifier | Mount Sinai Grants and Contract Office |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole grain rice | Experimental |
| |
| Refined grain rice | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Homeostatic Model Assessment (HOMA) Index | Estimates insulin resistance and β-cell function from fasting glucose and insulin levels | 0 |
| Homeostatic model assessment(HOMA) index | Estimates insulin resistance and β-cell function from fasting glucose and insulin levels | 6 weeks |
| Homeostatic model assessment (HOMA) index. | Estimates insulin resistance and β-cell function from fasting glucose and insulin levels | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Carboxymethyl lysine (CML) | Advanced glycation end product (in blood and urine) | 0, 6 and 12 weeks |
| Methylglyoxal (MG) | Advanced glycation end product (in blood and urine) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Uribarri, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12145012 | Background | McKeown NM, Meigs JB, Liu S, Wilson PW, Jacques PF. Whole-grain intake is favorably associated with metabolic risk factors for type 2 diabetes and cardiovascular disease in the Framingham Offspring Study. Am J Clin Nutr. 2002 Aug;76(2):390-8. doi: 10.1093/ajcn/76.2.390. | |
| 12197996 | Background | Fung TT, Hu FB, Pereira MA, Liu S, Stampfer MJ, Colditz GA, Willett WC. Whole-grain intake and the risk of type 2 diabetes: a prospective study in men. Am J Clin Nutr. 2002 Sep;76(3):535-40. doi: 10.1093/ajcn/76.3.535. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |
|
| 0, 6 and 12 weeks |
| IL-6 | Inflammatory marker | 0, 6 and 12 weeks |
| Receptor for advanced glycation endproducts (RAGE) | Receptor for advanced glycation endproducts | 0, 6 and 12 weeks |
| Sirtuin 1 | 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 |
| 12600852 | Background | Montonen J, Knekt P, Jarvinen R, Aromaa A, Reunanen A. Whole-grain and fiber intake and the incidence of type 2 diabetes. Am J Clin Nutr. 2003 Mar;77(3):622-9. doi: 10.1093/ajcn/77.3.622. |
| 14594783 | Background | Liese AD, Roach AK, Sparks KC, Marquart L, D'Agostino RB Jr, Mayer-Davis EJ. Whole-grain intake and insulin sensitivity: the Insulin Resistance Atherosclerosis Study. Am J Clin Nutr. 2003 Nov;78(5):965-71. doi: 10.1093/ajcn/78.5.965. |
| 12882946 | Background | Steffen LM, Jacobs DR Jr, Murtaugh MA, Moran A, Steinberger J, Hong CP, Sinaiko AR. Whole grain intake is associated with lower body mass and greater insulin sensitivity among adolescents. Am J Epidemiol. 2003 Aug 1;158(3):243-50. doi: 10.1093/aje/kwg146. |
| D006946 | Hyperinsulinism |