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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01720511
First received: October 30, 2012
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention
Type 2 Diabetic
Dietary Supplement: Purple Rice
Dietary Supplement: Brown Rice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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.

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: September 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Purple Rice
Twice a day given purple rice with 5mg of resveratrol.
Dietary Supplement: Purple Rice
Incorporate one cup of purple rice into dishes to be consumed at lunch and dinner each day for 4 weeks (equivalent of 4 ounces of uncooked rice/day).
Active Comparator: Brown RIce
Plain Purple rice given twice a day
Dietary Supplement: Brown Rice
Incorporate one cup of brown rice into dishes to be consumed at lunch and dinner each day for 4 weeks (equivalent of 4 ounces of uncooked rice/day).

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720511

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01720511     History of Changes
Other Study ID Numbers: PBRC 12002 
Study First Received: October 30, 2012
Last Updated: December 17, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 29, 2016