The Potential for Pomegranate Juice to Ameliorate Endothelial Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janet Novotny, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01748617
First received: December 10, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Healthy
Other: Controlled diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in endothelial function [ Time Frame: 0 hour and 3 hour ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: December 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pomegranate Juice
Acute ingestion of pomegranate juice with high fat meal.
Other: Controlled diet
1 week of controlled diet
Placebo Comparator: Control
Acute ingestion of juice-free sweetened beverage with high fat meal.
Other: Controlled diet
1 week of controlled diet

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748617

Locations
United States, Maryland
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
Janet Novotny
Investigators
Principal Investigator: Janet Novotny, Ph.D. USDA Beltsville Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: Janet Novotny, Principal Investigator, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01748617     History of Changes
Other Study ID Numbers: HS41
Study First Received: December 10, 2012
Last Updated: August 27, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 24, 2014