Expired Study
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Los Angeles, California 90095


Purpose:

The purpose of this study is to determine the efficacy of pomegranate extract and pomegranate juice on skin inflammation and aging. The information gained from this study may lead to the development of a pomegranate product that can decrease the effects of aging, inflammation and harmful bacteria on the skin. In this study, two pomegranate products (extract and juice) will be compared with a placebo, a study product that looks like pomegranate extract, but contains no active ingredients.


Study summary:

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 importance1. 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. In recent years, most health advantages of pomegranate have been attributed to the presence of ellagitannins, mainly punicalagins and ellagic acid. Punicalagin is unique to pomegranate and is part of a family of ellagitannins. The ellagitannins are hydrolyzed to ellagic acid in the gut, and further metabolized by the colon microflora to form urolith A and B. Investigations using pure bacterial cultures have shown that pomegranate by-products and punicalagins significantly inhibited the growth of pathogenic Escherichia coli, Pseudomonas aeruginosa, clostridia and Staphylococcus aureus. Oral feeding of pomegranate fruit extract to mice afforded protection to mouse skin against the adverse effects of ultraviolet-B (UVB) radiation by modulating UVB-induced signaling pathways.5 Hydroalcoholic extract based-ointment from pomegranate was reported improving wound healing in vivo. Pomegranate ellagitannins have been demonstrated to have antimicrobial activity. Punicalagin is unique to pomegranate and is part of a family of ellagitannins. The ellagitannins are hydrolyzed to ellagic acid in the gut, and further metabolized by the colon microflora to form urolith A and B. Investigations using pure bacterial cultures have shown that pomegranate by-products and punicalagins significantly inhibited the growth of pathogenic Escherichia coli, Pseudomonas aeruginosa, clostridia and Staphylococcus aureus. Pomegranate Extract (POMx) is made from pomegranate fruit as a byproduct of pomegranate juice (PJ) production. A second pressing of the fruit liberates a complex mixture of hydrolysable polyphenolic compounds normally ingested with pomegranate juice, and these are purified by spray drying. POMx powder is encapsulated for oral administration, with each capsule containing 1,000 mg of pomegranate polyphenols. The present study will determine whether a pomegranate product (POMx or PJ) can decrease skin photoaging, inflammation and skin pathogenic bacteria.


Criteria:

Inclusion Criteria: 1. Age 30-45 years or older, female and any racial/ethnic group 2. Subjects must understand and sign the informed consent prior to participation 3. Subjects must be in generally good health 4. Subjects must be able and willing to comply with the requirements of the protocol. Exclusion Criteria: 1. Oral or topical retinoid use within twelve months of entry into the study 2. Non-compliant subjects 3. Taking any antibiotics or other medication or dietary supplements regularly 4. Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for the study 5. Subjects who cannot avoid excessive exposure to either natural or artificial sunlight. 6. Allergic to pomegranate products


Study is Available At:


Original ID:

PomSkin 14-001011


NCT ID:

NCT02258776


Secondary ID:


Study Acronym:

PomSkin


Brief Title:

The Effect of Pomegranate on Aging and Inflammation of the Skin


Official Title:

Clinical Trial to Determine the Efficacy of Pomegranate for Skin Inflammation and Aging


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

30 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Los Angeles


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Actual


Overall Contact Information

Official Name:Zhaoping Li, M.D., Ph.D.
Principal Investigator
UCLA Department of Medicine

Study Dates

Start Date:October 2015
Completion Date:February 27, 2017
Completion Type:Actual
Primary Completion Date:February 27, 2017
Primary Completion Type:Actual
Verification Date:February 2017
Last Changed Date:February 27, 2017
First Received Date:September 26, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Linear mixed effects models to evaluate effect of treatment of time trends and demographic covariates
Time Frame:Baseline and 12 weeks
Safety Issues:False
Description:Correlation between outcomes measures (e.g. between acne lesion count and skin microbiota) with mixed effects models
Outcome Type:Primary Outcome
Measure:Change in inflammatory markers between pomegranate extract and pomegranate juice versus placebo.
Time Frame:Baseline and 12 weeks
Safety Issues:False
Description:Utilization of a two-sample t-test to compare the change in between the three groups

Study Interventions

Intervention Type:Dietary Supplement
Name:Pomegranate Extract
Description:Pomegranate extract 1000mg will be taken 1/day for 12 weeks.
Arm Name:Pomegranate Extract
Intervention Type:Dietary Supplement
Name:Pomegranate Juice
Description:Pomegranate juice 8oz will be consumed 1/day for 12 weeks.
Arm Name:Pomegranate Juice
Intervention Type:Dietary Supplement
Name:Placebo
Description:Placebo will be taken 1/day for 12 weeks.
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of placebo on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.
Study Arm Type:Active Comparator
Arm Name:Pomegranate Juice
Description:15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of pomegranate juice on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.
Study Arm Type:Active Comparator
Arm Name:Pomegranate Extract
Description:15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of pomegranate extract on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Los Angeles

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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