The Potential for Pomegranate Juice to Ameliorate Endothelial Dysfunction

Janet Novotny

Status

Completed

Conditions

Healthy

Treatments

Other: Controlled diet

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01748617

HS41

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

25 to 70 years old

Volunteers

Accepts Healthy Volunteers

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