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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248286
• Other study ID #: GCO 10-0924
• Secondary ID: 10-0924 0001 01
• Status: Completed
• Phase: N/A
• First received: November 17, 2010
• Last updated: October 21, 2013
• Start date: November 2010
• Est. completion date: April 2011

Study information

• Verified date: October 2013
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Glucose Intolerance
• Insulin Resistance
• Prediabetes
• Prediabetic State

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Montonen J, Knekt P, Järvinen 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostatic Model Assessment (HOMA) Index	Estimates insulin resistance and ß-cell function from fasting glucose and insulin levels	0	No
Primary	Homeostatic model assessment(HOMA) index	Estimates insulin resistance and ß-cell function from fasting glucose and insulin levels	6 weeks	No
Primary	Homeostatic model assessment (HOMA) index.	Estimates insulin resistance and ß-cell function from fasting glucose and insulin levels	12 weeks	No
Secondary	Carboxymethyl lysine (CML)	Advanced glycation end product (in blood and urine)	0, 6 and 12 weeks	No
Secondary	Methylglyoxal (MG)	Advanced glycation end product (in blood and urine)	0, 6 and 12 weeks	No
Secondary	IL-6	Inflammatory marker	0, 6 and 12 weeks	No
Secondary	Receptor for advanced glycation endproducts (RAGE)	Receptor for advanced glycation endproducts	0, 6 and 12 weeks	No
Secondary	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	No

External Links

•   Click here for more information about Jaime Uribarri, MD, the principal investigator of this study.