Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Other: Resveratrol 5mg |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 19 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Frank L. Greenway, MD | 225-763-3000 | doctors@pbrc.edu |
| United States, Louisiana | |
| Pennington Biomedical Research Center | Recruiting |
| Baton Rouge, Louisiana, United States, 70808 | |
| Contact: Grace Bella 225-763-3000 recruiters@pbrc.edu | |
| Principal Investigator: Frank L. Greenway, MD | |
| Sub-Investigator: John Finley, PhD | |
More Information
No publications provided
| Responsible Party: | Frank Greenway, Principal Investigator, Pennington Biomedical Research Center |
| ClinicalTrials.gov Identifier: | NCT01720511 History of Changes |
| Other Study ID Numbers: | PBRC12002 |
| Study First Received: | October 30, 2012 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Inflammation Pathologic Processes Resveratrol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Hematologic Agents Antimutagenic Agents Anticarcinogenic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013