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CompletedNCT01720511Updated Dec 18, 2015

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

An interventional study of Purple Rice and Brown Rice in Type 2 Diabetic, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-18.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetic

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

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Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Purple Rice

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

    Dietary Supplement: Purple Rice

  • Active comparator
    Brown RIce

    Plain Purple rice given twice a day

    Dietary Supplement: Brown Rice

Interventions

  • Dietary supplementPurple Rice

    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).

  • Dietary supplementBrown Rice

    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).

06

What researchers measure

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.

    Time frame: 10 weeks

Secondary outcomes

  1. 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.

    Time frame: 10 weeks

  2. 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.

    Time frame: 10 weeks

07

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01720511
Lead sponsor
Pennington Biomedical Research Center
Responsible party
Frank Greenway (Principal Investigator, Pennington Biomedical Research Center) — Principal investigator
First posted
Nov 2, 2012
Start date
Sep 2012
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Dec 18, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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