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

Pennington Biomedical Research Center

Status: Completed

Conditions: Type 2 Diabetic

Treatments: Dietary Supplement: Purple Rice; Dietary Supplement: Brown Rice

Study type: Interventional

Funder types: Other

Identifiers

NCT01720511

PBRC 12002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Purple Rice

Experimental group

Description:

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

Treatment:

Dietary Supplement: Purple Rice

Brown RIce

Active Comparator group

Description:

Plain Purple rice given twice a day

Treatment:

Dietary Supplement: Brown Rice