DiabetesNCT01248286
Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
A study testing Whole grain rice and Refined grain rice in people with Diabetes and Prediabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Prediabetes
- What is being tested?
- Whole grain rice and Refined grain rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Current smoker
- Consumption of greater than 2 alcoholic drinks per day
- History of malignancy and overt cardiovascular disease (apart from hypertension).
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
- Conditions
- Diabetes, Prediabetes
- Being tested
- Whole grain rice, Refined grain rice
- Keywords
- Diabetes, Prediabetes, Prevention, Whole grain, Advanced glycation end products, Insulin sensitivity
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grain riceOther
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 riceOther
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
| Study group | Role | What they receive |
|---|---|---|
| Whole grain rice | Experimental | Not described Receives: Other: Whole grain rice |
| Refined grain rice | Active comparator | Not described Receives: Other: Refined grain rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostatic Model Assessment (HOMA) Index
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Measured: 0
Homeostatic model assessment(HOMA) index
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Measured: 6 weeks
Homeostatic model assessment (HOMA) index.
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Measured: 12 weeks
Secondary outcomes (5)
Carboxymethyl lysine (CML)
Advanced glycation end product (in blood and urine)
Measured: 0, 6 and 12 weeks
Methylglyoxal (MG)
Advanced glycation end product (in blood and urine)
Measured: 0, 6 and 12 weeks
IL-6
Inflammatory marker
Measured: 0, 6 and 12 weeks
Receptor for advanced glycation endproducts (RAGE)
Receptor for advanced glycation endproducts
Measured: 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
Measured: 0, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaime Uribarri, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248286
- Sponsor's protocol ID
- GCO 10-0924
- Other IDs
- 10-0924 0001 01 ME
- Status last verified
- Oct 2013
- First submitted
- 17 Nov 2010
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12145012Fung 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.
PubMed 12197996Montonen 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.
PubMed 12600852Liese 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.
PubMed 14594783Steffen 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.
PubMed 12882946
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
- ClinicalTrials.gov ID
- NCT01248286
- Acronym / sponsor ID
- GCO 10-0924
- Conditions
- Diabetes, Prediabetes
- Keywords
- Diabetes, Prediabetes, Prevention, Whole grain, Advanced glycation end products, Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole grain rice | Experimental | Other: Whole grain rice |
| Refined grain rice | Active comparator | Other: Refined grain rice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole grain riceWhole 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 | Other | Whole grain rice |
| Refined grain riceRefined 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 | Other | Refined grain rice |
Primary outcome
Homeostatic Model Assessment (HOMA) Index
Time frame: 0
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Homeostatic model assessment(HOMA) index
Time frame: 6 weeks
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Homeostatic model assessment (HOMA) index.
Time frame: 12 weeks
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
5 secondary outcomes
Carboxymethyl lysine (CML)
Time frame: 0, 6 and 12 weeks
Methylglyoxal (MG)
Time frame: 0, 6 and 12 weeks
IL-6
Time frame: 0, 6 and 12 weeks
Receptor for advanced glycation endproducts (RAGE)
Time frame: 0, 6 and 12 weeks
Sirtuin 1
Time frame: 0, 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
- Background: PubMed 12145012McKeown 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.
- Background: PubMed 12197996Fung 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.
- Background: PubMed 12600852Montonen 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.
- Background: PubMed 14594783Liese 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.
- Background: PubMed 12882946Steffen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Uribarri, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole grain rice and Refined grain rice in people with Diabetes and Prediabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostatic Model Assessment (HOMA) Index (time frame: 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01248286, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.