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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Pomegranate Juice; Dietary Supplement: Placebo Juice

• Registration Number: NCT00668954
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-29
• Primary Completion: 2009-04
• Study Completion: 2010-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pomegranate Juice	Pomegranate Juice	-
Placebo Juice (non-Pomegranate)	Placebo Juice	-

Primary Outcome Measures

Name	Time	Method
Percent change of oxidant stress and lipid oxidation	baseline, week 6, week 12

Secondary Outcome Measures

Name	Time	Method
HbA1c	baseline, week 6, week 12
High Sensitivity C-reactive protein HsCRP	baseline, week 6, week 12

Trial Locations

Locations (1)

University of Colorado Denver Center for Human Nutrition; 🇺🇸 Denver, Colorado, United States