NCT01248286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

5 months

First QC Date

November 17, 2010

Last Update Submit

October 21, 2013

Conditions

DiabetesPrediabetes

Keywords

DiabetesPrediabetesPreventionWhole grainAdvanced glycation end productsInsulin sensitivity

Outcome Measures

Primary Outcomes (3)

  • Homeostatic Model Assessment (HOMA) Index

    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels

    0

  • Homeostatic model assessment(HOMA) index

    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels

    6 weeks

  • Homeostatic model assessment (HOMA) index.

    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels

    12 weeks

Secondary Outcomes (5)

  • Carboxymethyl lysine (CML)

    0, 6 and 12 weeks

  • Methylglyoxal (MG)

    0, 6 and 12 weeks

  • IL-6

    0, 6 and 12 weeks

  • Receptor for advanced glycation endproducts (RAGE)

    0, 6 and 12 weeks

  • Sirtuin 1

    0, 6 and 12 weeks

Study Arms (2)

Whole grain rice

EXPERIMENTAL
Other: Whole grain rice

Refined grain rice

ACTIVE COMPARATOR
Other: Refined grain rice

Interventions

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

Whole grain rice
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

Refined grain rice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (5)

  • 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.

    PMID: 12145012BACKGROUND

  • 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.

    PMID: 12197996BACKGROUND

  • 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.

    PMID: 12600852BACKGROUND

  • 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.

    PMID: 14594783BACKGROUND

  • 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.

    PMID: 12882946BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusPrediabetic StateInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Jaime Uribarri, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2010

First Posted

November 25, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

US(1)