Clinical trial NCT00668954: Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus
Official title: Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Pomegranate
Biomarkers
Antioxidant
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: POM Wonderful LLC
First posted: 2008-04-29
Enrollment: 26
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent change of oxidant stress and lipid oxidation
timeFrame: baseline, week 6, week 12
Secondary outcomes:
measure: HbA1c
timeFrame: baseline, week 6, week 12
measure: High Sensitivity C-reactive protein HsCRP
timeFrame: baseline, week 6, week 12
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver Center for Human Nutrition
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: James O. Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References: