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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668954
• Other study ID #: 07-0878
• Status: Completed
• Phase: N/A
• First received: April 25, 2008
• Last updated: July 29, 2015
• Start date: April 2008
• Est. completion date: November 2010

Study information

• Verified date: July 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Pomegranate Juice
Group A drinks 8 oz. pomegranate juice/day for 12 weeks
• Placebo Juice
Group B drinks 8 oz. placebo juice/day for 12 weeks

Locations

Country	Name	City	State
United States	University of Colorado Denver Center for Human Nutrition	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	POM Wonderful LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change of oxidant stress and lipid oxidation		baseline, week 6, week 12	No
Secondary	HbA1c		baseline, week 6, week 12	No
Secondary	High Sensitivity C-reactive protein HsCRP		baseline, week 6, week 12	No