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

• ClinicalTrials.gov Identifier: NCT03496584
• Recruitment Status: Terminated
• First Posted: April 12, 2018
• Last Update Posted: April 19, 2021
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Zhaoping Li, University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Erythema; Inflammation	Other: Pomegranate Juice; Other: Placebo Juice	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effects of Phytonutrients on Vascular and Skin Health and Systemic Inflammation in Obese Men
• Actual Study Start Date: March 29, 2018
• Actual Primary Completion Date: February 28, 2021
• Actual Study Completion Date: February 28, 2021

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. Change in erythema dose [ Time Frame: Baseline and 12 weeks ]
   Assess the effect of pom juice consumption on skin resistance to UV radiation (minimal erythema dose)

Secondary Outcome Measures :

1. Change in systemic inflammation [ Time Frame: Baseline and 12 weeks ]
   2. Assess the effect of pom juice consumption on systemic inflammation (serum cytokine concentration)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

UCLA Center for Human Nutriiton

Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

Investigators

• Principal Investigator: Zhaoping Li, MD, PhD; University of California, Los Angeles

More Information

• Responsible Party: Zhaoping Li, Professor of Medicine, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03496584
• Other Study ID Numbers: 17-001781
• First Posted: April 12, 2018
• Last Update Posted: April 19, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Erythema; Inflammation; Pathologic Processes; Skin Diseases; Skin Manifestations