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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation.|
- 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.
- 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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Resveratrol 5mg
Twice a day given purple rice with 5mg of resveratrol.
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).
Placebo Comparator: placebo
Plain Purple rice given twice a day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720511
|Contact: Frank L. Greenway, MDemail@example.com|
|United States, Louisiana|
|Pennington Biomedical Research Center||Recruiting|
|Baton Rouge, Louisiana, United States, 70808|
|Contact: Grace Bella 225-763-3000 firstname.lastname@example.org|
|Principal Investigator: Frank L. Greenway, MD|
|Sub-Investigator: John Finley, PhD|