Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01720511
First received: October 30, 2012
Last updated: June 6, 2014
Last verified: June 2014

October 30, 2012
June 6, 2014
September 2012
May 2015   (final data collection date for primary outcome measure)
Glucose Tolerance [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Subjects will have an Intravenous line placed and fasting blood will be drawn. Subjects will then be given glucose to drink and blood will be drawn from an IV line for glucose and insulin.
Same as current
Complete list of historical versions of study NCT01720511 on ClinicalTrials.gov Archive Site
  • Serum Lipids [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Subjects will have an Intravenous line placed and fasting blood will be drawn for a chemistry-15 panel and High-sensitivity C-reaction Protein. Subjects will then be given 75 grams of glucose to drink and blood will be drawn from an IV line for glucose and insulin.
  • Inflammation measured by highly sensitive C-reative protein test [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    A high-sensitivity CRP (hs-CRP), that can be done in the lab using a blood test.
  • Serum Lipids [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Subjects will have an Intravenous line placed and fasting blood will be drawn for a chemistry-15 panel and High-sensitivity C-reaction Protein. Subjects will then be given 75 grams of glucose to drink and blood will be drawn from an IV line for glucose and insulin.
  • Inflammation [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation
Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation.

This is a pilot study to demonstrate the effect of purple rice on post-prandial glucose and insulin. The purple color is due, like red wine grapes, mainly to the anthocyanins. The safety and tolerability of purple rice is similar to white or brown rice, but contains the purple elements common to other foods like grapes.

This is a study that will have 1 screening visit and 9 study visits. Subjects will come to the screening visit for blood chemistry, health questionnaire and speak to the coordinator. Each subject passing inclusion/exclusion will go on to eat purple rice for 4 weeks and brown rice for 4 weeks. The 4-week feeding periods will be balanced and assigned randomly. The subjects will report to the metabolic kitchen to pick up their supply of 14 frozen rice dishes each week in a container and return the empty containers as a measure of compliance. At the end of each 4-week feeding period, subjects will come to the inpatient unit fasting from 9pm the prior night except for water. Subjects will have an intravenous line placed and fasting blood will be drawn for chemistry. Subjects will then be given glucose to drink and blood will be drawn from then IV line for glucose and insulin at time listed in the consent.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Type 2 Diabetic
Other: Resveratrol 5mg
Incorporate one cup of purple or brown rice with resveratrol into dishes to be consumed at lunch and dinner each day for 4 weeks (equivalent of 4 ounces of uncooked rice/day).
  • Experimental: Resveratrol 5mg
    Twice a day given purple rice with 5mg of resveratrol.
    Intervention: Other: Resveratrol 5mg
  • Placebo Comparator: placebo
    Plain Purple rice given twice a day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
19
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Generally healthy male or female with a fasting glucose between 100 mg/mL and 126 mg/dL or with type 2 diabetes controlled on diet without diabetes medications.
  • Eighteen years of age or older.
  • Hemoglobin A1c(HgbA1c) less than 7%.

Exclusion Criteria:

  • Pregnant or nursing.
  • Taking a medication for diabetes (e.g. Metformin), a medication known to affect blood sugar (e.g. glucocorticoids), an anti-inflammatory medication (e.g. aspiring) or triglycerides (e.g. fibrates).
  • Any chronic medication that has not had a stable dose for 1 month or longer.
Both
18 Years and older
Yes
Contact: Frank L. Greenway, MD 225-763-3000 doctors@pbrc.edu
United States
 
NCT01720511
PBRC12002
No
Frank Greenway, Pennington Biomedical Research Center
Pennington Biomedical Research Center
Not Provided
Not Provided
Pennington Biomedical Research Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP