ErythemaPomSkinNCT03496584
Effects of Phytonutrients on Vascular Health and Skin in Obese Males
A study testing Pomegranate Juice in people with Erythema and Inflammation, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erythema, Inflammation
- What is being tested?
- Pomegranate Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2018to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutriiton
Los Angeles, California, 90095
About this study
Official title: Effects of Phytonutrients on Vascular and Skin Health and Systemic Inflammation in Obese Men
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.
Read the 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.
- Conditions
- Erythema, Inflammation
- Being tested
- Pomegranate Juice, Placebo Juice
- Medical subject headings
- Erythema, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate JuiceOther
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 JuiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate Juice | Active comparator | 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. Receives: Other: Pomegranate Juice |
| Placebo Juice | Placebo comparator | 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. Receives: Other: Placebo Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erythema dose
Assess the effect of pom juice consumption on skin resistance to UV radiation (minimal erythema dose)
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Change in systemic inflammation
- Assess the effect of pom juice consumption on systemic inflammation (serum cytokine concentration)
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start29 Mar 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: No funding to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496584
- Sponsor's protocol ID
- 17-001781
- Acronym
- PomSkin
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2018
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phytonutrients on Vascular and Skin Health and Systemic Inflammation in Obese Men
- ClinicalTrials.gov ID
- NCT03496584
- Acronym / sponsor ID
- PomSkin / 17-001781
- Conditions
- Erythema, Inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funding to complete study
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate Juice | Active comparator | Other: Pomegranate JuicePostprandial 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. |
| Placebo Juice | Placebo comparator | Other: Placebo JuicePostprandial 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomegranate JuiceAfter 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. | Other | Pomegranate Juice |
| Placebo JuiceAfter 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. | Other | Placebo Juice |
Primary outcome
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)
1 secondary outcome
Change in systemic inflammation
Time frame: Baseline and 12 weeks
Results and safety
The study was stopped early (reason given: No funding to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate Juice in people with Erythema and Inflammation, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No funding to complete study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in erythema dose (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.