Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
Primary Purpose
Diabetes, Prediabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole grain rice
Refined grain rice
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes focused on measuring Diabetes, Prediabetes, Prevention, Whole grain, Advanced glycation end products, Insulin sensitivity
Eligibility Criteria
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).
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole grain rice
Refined grain rice
Arm Description
Outcomes
Primary Outcome Measures
Homeostatic Model Assessment (HOMA) Index
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Homeostatic model assessment(HOMA) index
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Homeostatic model assessment (HOMA) index.
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Secondary Outcome Measures
Carboxymethyl lysine (CML)
Advanced glycation end product (in blood and urine)
Methylglyoxal (MG)
Advanced glycation end product (in blood and urine)
IL-6
Inflammatory marker
Receptor for advanced glycation endproducts (RAGE)
Receptor for advanced glycation endproducts
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
Full Information
NCT ID
NCT01248286
First Posted
November 17, 2010
Last Updated
October 21, 2013
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT01248286
Brief Title
Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
Official Title
Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Prediabetes
Keywords
Diabetes, Prediabetes, Prevention, Whole grain, Advanced glycation end products, Insulin sensitivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole grain rice
Arm Type
Experimental
Arm Title
Refined grain rice
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Whole grain rice
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Refined grain rice
Intervention Description
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 Outcome Measure Information:
Title
Homeostatic Model Assessment (HOMA) Index
Description
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Time Frame
0
Title
Homeostatic model assessment(HOMA) index
Description
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Time Frame
6 weeks
Title
Homeostatic model assessment (HOMA) index.
Description
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Carboxymethyl lysine (CML)
Description
Advanced glycation end product (in blood and urine)
Time Frame
0, 6 and 12 weeks
Title
Methylglyoxal (MG)
Description
Advanced glycation end product (in blood and urine)
Time Frame
0, 6 and 12 weeks
Title
IL-6
Description
Inflammatory marker
Time Frame
0, 6 and 12 weeks
Title
Receptor for advanced glycation endproducts (RAGE)
Description
Receptor for advanced glycation endproducts
Time Frame
0, 6 and 12 weeks
Title
Sirtuin 1
Description
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
Time Frame
0, 6 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Uribarri, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12145012
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. doi: 10.1093/ajcn/76.2.390.
Results Reference
background
PubMed Identifier
12197996
Citation
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.
Results Reference
background
PubMed Identifier
12600852
Citation
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.
Results Reference
background
PubMed Identifier
14594783
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. doi: 10.1093/ajcn/78.5.965.
Results Reference
background
PubMed Identifier
12882946
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. doi: 10.1093/aje/kwg146.
Results Reference
background
Links:
URL
http://www.mountsinai.org/profiles/jaime-uribarri
Description
Click here for more information about Jaime Uribarri, MD, the principal investigator of this study.
Learn more about this trial
Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
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