Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation
| Tracking Information | |||||
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| First Received Date ICMJE | October 30, 2012 | ||||
| Last Updated Date | May 13, 2013 | ||||
| Start Date ICMJE | September 2012 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01720511 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation | ||||
| Official Title ICMJE | Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation. | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE | Type 2 Diabetic | ||||
| Intervention ICMJE | 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). |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 19 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01720511 | ||||
| Other Study ID Numbers ICMJE | PBRC12002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Frank Greenway, Pennington Biomedical Research Center | ||||
| Study Sponsor ICMJE | Pennington Biomedical Research Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Pennington Biomedical Research Center | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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