The Potential for Pomegranate Juice to Ameliorate Endothelial Dysfunction

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.

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Key information

Conditions

Healthy

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled diet

Other

1 week of controlled diet

Primary outcomes

Change in endothelial function

Time frame: 0 hour and 3 hour

After a consuming controlled diet for 1 week, subjects will report in the morning after a 12 hour fast. Upon arrival , subjects' endothelial function will be assessed by measuring endothelium-dependent flow mediated dilation of the peripheral bed (EndoPAT, Itamar Medical, Israel). For this test, subjects will rest in the supine position with a brachial blood pressure cuff on one arm and a finger tip probe on each of two fingers (one on the left hand, one on the right hand). After 5 minutes of rest, the blood pressure cuff will be inflated and remain inflated for 5 minutes. Then the cuff pressure will be released and the subject will remain resting for 5 additional minutes. This test will be repeated 3 hours after the test meal.

Sponsors and collaborators

Lead sponsor

Janet Novotny

Fed

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Dec 12, 2012
Registry last updated: Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed