- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01720511
Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation
December 17, 2015 updated by: Frank Greenway, Pennington Biomedical Research Center
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Purple Rice
Twice a day given purple rice with 5mg of resveratrol.
|
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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Tolerance
Time Frame: 10 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Lipids
Time Frame: 10 weeks
|
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.
|
10 weeks
|
Inflammation measured by highly sensitive C-reative protein test
Time Frame: 10 weeks
|
A high-sensitivity CRP (hs-CRP), that can be done in the lab using a blood test.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ACTUAL)
October 1, 2015
Study Completion (ACTUAL)
October 1, 2015
Study Registration Dates
First Submitted
October 30, 2012
First Submitted That Met QC Criteria
October 31, 2012
First Posted (ESTIMATE)
November 2, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
December 18, 2015
Last Update Submitted That Met QC Criteria
December 17, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 12002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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