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

Type 2 Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720511
• Other study ID #: PBRC 12002
• Status: Completed
• Phase: N/A
• First received: October 30, 2012
• Last updated: December 17, 2015
• Start date: September 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Type 2 Diabetic

Intervention

Dietary Supplement:
• Purple 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).
• Brown 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).

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 weeks	No
Secondary	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.	10 weeks	No
Secondary	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.	10 weeks	No