The Potential for Pomegranate Juice to Ameliorate Endothelial Dysfunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Change in endothelial function
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Janet Novotny
Principal Investigator
USDA Beltsville Human Nutrition Research Center