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Terminated
No funding to complete study

Effects of Phytonutrients on Vascular Health and Skin in Obese Males (PomSkin)

ClinicalTrials.gov ID NCT03496584
Sponsor University of California, Los Angeles
Information provided by Zhaoping Li, University of California, Los Angeles (Responsible Party)
Last Update Posted 2021-04-19
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Study Overview

Brief Summary

This study will determine the effects of beneficial compounds of plant foods, such as pomegranate on cardiovascular health, skin inflammation and aging. This will be tested by asking healthy males to eat a high fat ground beef patty with 8oz. pomegranate juice or 8oz placebo (a study product that looks like pomegranate juice, but contains no active ingredients) and then measuring blood vessel dilation (endothelial function) by blood flow. The investigators also will measure the amount of Nitric Oxide (NO) in blood and urine samples and sugar and insulin in blood. In addition, a Cutometer, a device that measures the elasticity of the skin, will be used to obtain measurements of skin inflammation and aging.

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 and the skin.

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Detailed Description
The proposed investigation has two major objectives: 1. to determine the clinical efficacy of pomegranate juice to reduce skin aging by assessing UV-induced change and skin biological characteristics of elasticity, sebum, hydration/moisture and systemic inflammation and 2. To determine the impact of pomegranate polyphenols on the metabolic response to a high fat meal by postprandial flow-mediated dilation and plasma nitric oxide. The investigators propose to achieve the following specific aims in a randomized, two arm, parallel intervention of pomegranate juice or placebo for 12 weeks in obese men.
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Official Title
Effects of Phytonutrients on Vascular and Skin Health and Systemic Inflammation in Obese Men
Conditions
Erythema
Inflammation
Intervention / Treatment
  • Other: Pomegranate Juice
  • Other: Placebo Juice
  • Other: Pomegranate Juice
  • Other: Placebo Juice
Other Study ID Numbers
  • 17-001781
Study Start (Actual)
2018-03-29
Primary Completion (Actual)
2021-02-28
Study Completion (Actual)
2021-02-28
Enrollment (Actual)
35
Study Type
Interventional
Phase
Not Applicable

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
California Locations
Los Angeles, California, United States, 90095

UCLA Center for Human Nutriiton
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  • 18 - 65 years old males (inclusive)
  • BMI range from 30 to 45 (inclusive)
  • Non-smokers
  • Fitzpatrick Skin type II-IV
  • 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.

Exclusion Criteria:

  • Any subject with a history of diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
  • Known cardiovascular disease, as defined by a self-reported history or medical record documentation of any of the following: myocardial infarction, angina pectoris, prior revascularization (coronary artery bypass graft, percutaneous coronary intervention), peripheral vascular disease, arrhythmias, congestive heart failure, congenital heart disease, cerebrovascular disease (stroke, transient ischemic attack).
  • History of known vascular disorder or autoimmune processes including Crohn's disease, ulcerative colitis, severe psoriasis, rheumatoid arthritis, and cryoglobulinemia that may affect vascular studies.
  • History of skin cancer (melanoma or non-melanoma), xeroderma, pigmetosum, systemic lupus erythematosus, or dermatomyositis.
  • Any subject who is taking photosensitizing medications, i.e. Ibuprofen, Naprosyn, furosemide, hydrochlorothiazide, isotretinoin statins, and phenothizaones.
  • Any subject who is taking vasoactive medications (such as nitrates, calcium channel blockers, and beta-blockers)
  • Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
  • 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
  • Allergy or sensitivity to pomegranate products
  • Follows a vegetarian, vegan or beef-free diet
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Ages Eligible for Study
18 Years to 65 Years (AdultOlder Adult )
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Prevention
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Double (ParticipantInvestigator)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Active Comparator: Pomegranate Juice
Postprandial high fat meal will be administered with pomegranate juice with the first dose of the intervention, Pomegranate Juice , followed by 12 weeks of pomegranate juice consumption.
Intervention/Treatment Other: Pomegranate Juice
  • After the one week run-in period of consuming an ellagitannin-free diet, participants will undergo the skin testing followed by the postprandial meal test with a high fat (HF) test meal consumed with the first dose of the intervention (Pom J or placebo). For the next 12 weeks, participants will consume a daily dose of pomegranate juice 1x/day. During week 4 participants will undergo another skin testing. During week 12 participants will undergo another skin testing and postprandial meal challenge. Stool will be collected at week 1, 4 and 12.

Participant Group/Arm Placebo Comparator: Placebo Juice
Postprandial high fat meal will be administered with pomegranate juice with the first dose of the intervention, Placebo Juice , followed by 12 weeks of pomegranate juice consumption.
Intervention/Treatment Other: Placebo Juice
  • After the one week run-in period of consuming an ellagitannin-free diet, participants will undergo the skin testing followed by the postprandial meal test with a high fat (HF) test meal consumed with the first dose of the intervention (Pom J or placebo). For the next 12 weeks, participants will consume a daily dose of placebo juice 1x/day. During week 4 participants will undergo another skin testing. During week 12 participants will undergo another skin testing and postprandial meal challenge. Stool will be collected at week 1, 4 and 12.

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Change in erythema doseAssess the effect of pom juice consumption on skin resistance to UV radiation (minimal erythema dose)Baseline and 12 weeks
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Change in systemic inflammation2. Assess the effect of pom juice consumption on systemic inflammation (serum cytokine concentration)Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
University of California, Los Angeles
Investigators
  • Principal Investigator:Zhaoping Li, MD, PhD,University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2018-03-29
First Submitted that Met QC Criteria
2018-04-05
First Posted
2018-04-12
Study Record Updates
Last Update Submitted that met QC Criteria
2021-04-14
Last Update Posted
2021-04-19
Last Verified
2021-04

More Information

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Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No