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

Not Applicable

Completed

• Conditions: Diabetes; Prediabetes
• Interventions: Other: Whole grain rice; Other: Refined grain rice

• Registration Number: NCT01248286
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-23
• Study First Posted: 2010-11-25
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-21
• Last Update Posted: 2013-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole grain rice	Whole grain rice	-
Refined grain rice	Refined grain rice	-

Primary Outcome Measures

Name	Time	Method
Homeostatic model assessment(HOMA) index	6 weeks	Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Homeostatic Model Assessment (HOMA) Index	0	Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Homeostatic model assessment (HOMA) index.	12 weeks	Estimates insulin resistance and β-cell function from fasting glucose and insulin levels

Secondary Outcome Measures

Name	Time	Method
IL-6	0, 6 and 12 weeks	Inflammatory marker
Sirtuin 1	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
Methylglyoxal (MG)	0, 6 and 12 weeks	Advanced glycation end product (in blood and urine)
Receptor for advanced glycation endproducts (RAGE)	0, 6 and 12 weeks	Receptor for advanced glycation endproducts
Carboxymethyl lysine (CML)	0, 6 and 12 weeks	Advanced glycation end product (in blood and urine)

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States