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

Primary Purpose

Erythema, Inflammation

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pomegranate Juice

Placebo Juice

About this trial

This is an interventional prevention trial for Erythema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

UCLA Center for Human Nutriiton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pomegranate Juice

Placebo Juice

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in erythema dose

Assess the effect of pom juice consumption on skin resistance to UV radiation (minimal erythema dose)

Secondary Outcome Measures

Change in systemic inflammation

2. Assess the effect of pom juice consumption on systemic inflammation (serum cytokine concentration)

Full Information

NCT ID

NCT03496584

First Posted

March 29, 2018

Last Updated

April 14, 2021

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT03496584

Brief Title

Effects of Phytonutrients on Vascular Health and Skin in Obese Males

Acronym

PomSkin

Official Title

Effects of Phytonutrients on Vascular and Skin Health and Systemic Inflammation in Obese Men

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

No funding to complete study

Study Start Date

March 29, 2018 (Actual)

Primary Completion Date

February 28, 2021 (Actual)

Study Completion Date

February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erythema, Inflammation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pomegranate Juice

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo Juice

Arm Type

Placebo Comparator

Arm Description

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 Type

Other

Intervention Name(s)

Pomegranate Juice

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo Juice

Intervention Description

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 Measure Information:

Title

Change in erythema dose

Description

Assess the effect of pom juice consumption on skin resistance to UV radiation (minimal erythema dose)

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in systemic inflammation

Description

2. Assess the effect of pom juice consumption on systemic inflammation (serum cytokine concentration)

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoping Li, MD, PhD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA Center for Human Nutriiton

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Phytonutrients on Vascular Health and Skin in Obese Males

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