Effects of Phytonutrients on Vascular Health

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Pomegranate extract; Other: Water; Dietary Supplement: Pomegranate Juice

• Registration Number: NCT02605850
• Lead Sponsor: University of California, Los Angeles

Brief Summary

This study will determine the effects of beneficial compounds of plant foods, such as pomegranate on cardiovascular health. This will be tested by asking healthy males to eat a high fat ground beef patty with pomegranate juice (PJ), pomegranate extract (PomX) or water and then measuring blood vessel dilation (endothelial function) by blood flow We also will measure the amount of Nitric Oxide (NO) in your blood and urine samples and sugar and insulin in blood. Healthy men have been chosen for this study because eating high fat hamburger patties can easily mimic in them the condition that causes atherosclerosis. The results from this study may help to explain how high fat foods can be harmful to the body and how beneficial plant foods can have on cardiovascular function

Detailed Description

A. Specific Aims and Objectives

1. Peripheral arterial reactivity by tonometry after a high fat meal with pomegranate consumption

2. To measure nitric oxide and insulin response after a high fat meal and pomegranate consumption These studies will lead to a better understanding of the role of bioactive substances from plant foods such as the pomegranate may demonstrate the importance of plant-based nutrients on cardiovascular health.

B. Background Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly, in response to biotic or abiotic stresses such as infections, wounding, UV irradiation, exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that the molecular basis for the protective action of polyphenols in plants is their antioxidant and free radical scavenging properties.

Pomegranate (Punica granatum L.) is grown commercially in the Near East, India, Spain, Israel and the United States (California) where it is of significant economic importance. Pomegranate fruits and products, including juice, tea, wine and extracts are widely consumed and recognized for their health benefits. Pomegranate (Punica granatum L.) fruit possesses strong antioxidant, anti-inflammatory and antiproliferative properties.

High-calorie meals rich in saturated fat can lead to transient exaggerated elevations in blood glucose, free fatty acids, and triglycerides. This condition, termed postprandial dysmetabolism, generates excess free radicals (or reactive oxygen species). The ensuing oxidative stress triggers a biochemical cascade throughout the circulation, inducing inflammation, and endothelial dysfunction. These postprandial changes, when repeated multiple times each day, can create a milieu conducive for the development of atherosclerotic risk factors and coronary heart disease (CHD).

In order to investigate the impact of pomegranate polyphenols on postprandial flow-mediated dilation, nitric oxide, glucose, insulin, triglycerides levels in men, we propose to achieve the following specific aims using a randomized study design:

1. Peripheral arterial reactivity by tonometry after a high fat meal with pomegranate consumption

2. To measure nitric oxide and insulin response after a high fat meal and pomegranate consumption

Study Timeline

• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-16
• Study Start: 2016-01
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-30
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• 18 - 35 years old males (inclusive)
• Non-smokers
• Must weigh a minimum of 110 pounds
• Willing to maintain normal activity and eating patterns for the duration of the study
• Willing to maintain their normal diet for the duration of the study but avoid pomegranate products and ellagitannin rich foods.

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Exclusion Criteria

• Any chronic medical conditions
• Abnormal liver function (AST and ALT > 2 x upper limit)
• Currently taking steroidal drugs
• Cancer treated within the past two years
• Participation in a therapeutic research study within 30 days of baseline
• Use of antibiotics within one month
• Regular use of probiotics
• Allergy or sensitivity to pomegranate products
• Follow a vegetarian diet
• Known HIV positive

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ground beef patty + Pomegranate Extract	Pomegranate extract	32 healthy subjects, ages 18-35 years who meet all the eligibility criteria in the screening phase of the study will receive the ground beef patty + water to evaluate the clinical efficacy of pomegranate on vascular health.Then subjects will be randomized to consume pomegranate juice or extract. At visit 2, subjects will be tested before and after meal with pomegranate juice or extract, then take pomegranate product daily for 4 weeks. At visit 3, subjects will tested before and after test meal with pomegranate products.
Ground beef patty + Water	Water	32 healthy subjects, ages 18-35 years who meet all the eligibility criteria in the screening phase of the study will receive the ground beef patty + water to evaluate the clinical efficacy of pomegranate on vascular health.Then subjects will be randomized to consume pomegranate juice or extract. At visit 2, subjects will be tested before and after meal with pomegranate juice or extract, then take pomegranate product daily for 4 weeks. At visit 3, subjects will tested before and after test meal with pomegranate products.
Ground beef patty + Pomegranate Juice	Pomegranate Juice	32 healthy subjects, ages 18-35 years who meet all the eligibility criteria in the screening phase of the study will receive the ground beef patty + water to evaluate the clinical efficacy of pomegranate on vascular health.Then subjects will be randomized to consume pomegranate juice or extract. At visit 2, subjects will be tested before and after meal with pomegranate juice or extract, then take pomegranate product daily for 4 weeks. At visit 3, subjects will tested before and after test meal with pomegranate products.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Abnormal PAT Values That Are Related to Treatment	Change from Baseline vascular function at 6 weeks	The major outcomes are PAT changes after a test meal with and without pomegranate.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Abnormal Laboratory Values That Are Related to Treatment	Change from Baseline laboratory values at 6 weeks	Correlation between outcomes measures (e.g. between nitric oxide and insulin response) with mixed effects models.