Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
Public ClinicalTrials.gov record NCT01248286. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01248286
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2010
- Primary completion
- Mar 31, 2011
- Completion
- Mar 31, 2011
- Last update posted
- Oct 21, 2013
2010 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01248286, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 21, 2013 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01248286 live on ClinicalTrials.gov.