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The Potential for Pomegranate Juice to Ameliorate Endothelial Dysfunction

NCT ID: NCT01748617

Last Updated: 2013-08-28

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-01-31

Brief Summary

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This study will be a randomized, double-blind, crossover intervention to investigate the health effects of acute ingestion of pomegranate juice when consumed with a high fat meal. After one week of controlled dietary intervention, subjects will consume a high fat morning meal supplemented with either pomegranate juice or a juice-free sweetened beverage. After consumption of the breakfast meal, subjects will be assessed for endothelial function and postprandial meal response.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pomegranate Juice

Acute ingestion of pomegranate juice with high fat meal.

Group Type EXPERIMENTAL

Controlled diet

Intervention Type OTHER

1 week of controlled diet

Control

Acute ingestion of juice-free sweetened beverage with high fat meal.

Group Type PLACEBO_COMPARATOR

Controlled diet

Intervention Type OTHER

1 week of controlled diet

Interventions

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Controlled diet

1 week of controlled diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women between the ages of 25-70 years
* Body mass index (BMI) ≥ 19 and ≤ 38
* Willingness and ability to make scheduled appointments at clinical site as required by study protocol

Exclusion Criteria

* Known (self-reported) allergy or adverse reaction to study foods
* Presence of kidney disease, liver disease, gout, untreated or unstable hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* Fasting triglycerides \> 300 mg/dL
* Fasting glucose \> 126 mg/dL
* Use of cholesterol lowering medication
* Blood pressure \> 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
* Fingernails longer than 0.25 inch beyond the finger tip, or unwillingness to cut fingernails to this length during endothelial function testing
* History of bariatric or certain other surgeries related to weight control
* History of major surgery within 3 months of enrollment
* Smokers or other tobacco users (during 6 months prior to the start of the study)
* Antibiotic use during the intervention or for 3 months prior to the intervention period
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Volunteers who have lost 10% of body weight within the last 6 months
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janet Novotny

FED

Sponsor Role lead

Responsible Party

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Janet Novotny

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Janet Novotny, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

USDA Beltsville Human Nutrition Research Center

Locations

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USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HS41

Identifier Type: -

Identifier Source: org_study_id