Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Placebo Juice; Dietary Supplement: Pomegranate Juice

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00668954

07-0878

Details and patient eligibility

About

This is a research study designed to look at how pomegranate juice (or a placebo juice) affects the body through the measurement of specific biomarkers, which are indicators of health.

Full description

This research study will evaluate how pomegranate juice (or a placebo juice) affects the body. Participants will be asked to drink 8 oz. of juice daily for 12 weeks. Biomarkers, which are indicators of health, will be measured throughout the study. They are present in blood and urine. The placebo is a juice that is not made from pomegranates, but resembles pomegranate juice in color and taste. Eating pomegranates has been shown to have a positive impact on certain biomarkers. Recent studies have shown that biomarkers can be indicators of general health. The investigators want to know if drinking pomegranate juice daily for 12 weeks is effective at improving a variety of biomarkers in diabetic adults.

Enrollment: 26 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to speak and read English
• Have a diagnosis of Type II Diabetes Mellitus and currently being treated with oral medication
• Have an HbA1C level ≤9.0% at Screening
• Have an hsCRP level ≥ 1.0 at Screening
• 35 - 70 years old (inclusive)
• Non-smokers
• Willing to maintain his/her normal activity and eating patterns for the duration of the study
• Willing to maintain his/her normal diet for the duration of the study but avoid anti-oxidant rich foods and pomegranate juice (other than what is dispensed to them)

Exclusion criteria

• Allergy to pomegranates
• Currently using insulin
• Currently taking steroidal drugs
• HIV positive or AIDS
• Chronic infectious disease
• Recent (within 2 weeks of screening) cold/flu, inflammatory illness, or flare-up of gout
• Cancer treated within the past two years
• Participation in a therapeutic research study within 30 days of baseline
• Women who are pregnant, lactating, or planning to become pregnant during the study period

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Pomegranate Juice

Active Comparator group

Treatment:

Dietary Supplement: Pomegranate Juice

Placebo Juice (non-Pomegranate)

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo Juice