Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 30, 2012
CompletedFirst Posted
Study publicly available on registry
November 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 18, 2015
December 1, 2015
3.1 years
October 30, 2012
December 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose Tolerance
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.
10 weeks
Secondary Outcomes (2)
Serum Lipids
10 weeks
Inflammation measured by highly sensitive C-reative protein test
10 weeks
Study Arms (2)
Purple Rice
EXPERIMENTALTwice a day given purple rice with 5mg of resveratrol.
Brown RIce
ACTIVE COMPARATORPlain Purple rice given twice a day
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 30, 2012
First Posted
November 2, 2012
Study Start
September 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 18, 2015
Record last verified: 2015-12