The Potential for Pomegranate Juice to Ameliorate Endothelial Dysfunction

NCT01748617 | Completed

• 1 other identifier: HS41
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in endothelial function

  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.

  0 hour and 3 hour

Study Arms (2)

Pomegranate Juice

EXPERIMENTAL

Acute ingestion of pomegranate juice with high fat meal.

Other: Controlled diet

Control

PLACEBO COMPARATOR

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

Other: Controlled diet

Interventions

Controlled diet OTHER

1 week of controlled diet

Control; Pomegranate Juice

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janet Novotny: lead

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Officials

• Janet Novotny, Ph.D.

  USDA Beltsville Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

US (1)