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

Primary Purpose

Type 2 Diabetic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Purple Rice
Brown Rice
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Purple Rice

Brown RIce

Arm Description

Twice a day given purple rice with 5mg of resveratrol.

Plain Purple rice given twice a day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum Lipids
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
A high-sensitivity CRP (hs-CRP), that can be done in the lab using a blood test.

Full Information

First Posted
October 30, 2012
Last Updated
December 17, 2015
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01720511
Brief Title
Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation
Official Title
Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Purple Rice
Arm Type
Experimental
Arm Description
Twice a day given purple rice with 5mg of resveratrol.
Arm Title
Brown RIce
Arm Type
Active Comparator
Arm Description
Plain Purple rice given twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Purple Rice
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Brown Rice
Intervention Description
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).
Primary Outcome Measure Information:
Title
Glucose Tolerance
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Serum Lipids
Description
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.
Time Frame
10 weeks
Title
Inflammation measured by highly sensitive C-reative protein test
Description
A high-sensitivity CRP (hs-CRP), that can be done in the lab using a blood test.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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

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