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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pomegranate Juice

Group Type ACTIVE_COMPARATOR

Pomegranate Juice

Intervention Type DIETARY_SUPPLEMENT

Group A drinks 8 oz. pomegranate juice/day for 12 weeks

Placebo Juice (non-Pomegranate)

Group Type PLACEBO_COMPARATOR

Placebo Juice

Intervention Type DIETARY_SUPPLEMENT

Group B drinks 8 oz. placebo juice/day for 12 weeks

Interventions

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Pomegranate Juice

Group A drinks 8 oz. pomegranate juice/day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo Juice

Group B drinks 8 oz. placebo juice/day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No