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The Effect of Pomegranate on Aging and Inflammation of the Skin (PomSkin)

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ClinicalTrials.gov Identifier: NCT02258776
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Skin Photoaging, Inflammation and Skin Pathogenic Bacteria Dietary Supplement: Pomegranate Extract Dietary Supplement: Pomegranate Juice Dietary Supplement: Placebo Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Clinical Trial to Determine the Efficacy of Pomegranate for Skin Inflammation and Aging
Study Start Date : October 2015
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : February 27, 2017

Arm Intervention/treatment
Active Comparator: Pomegranate Extract
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.
Dietary Supplement: Pomegranate Extract
Pomegranate extract 1000mg will be taken 1/day for 12 weeks.

Active Comparator: Pomegranate Juice
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.
Dietary Supplement: Pomegranate Juice
Pomegranate juice 8oz will be consumed 1/day for 12 weeks.

Placebo Comparator: Placebo
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.
Dietary Supplement: Placebo
Placebo will be taken 1/day for 12 weeks.




Primary Outcome Measures :
  1. Change in inflammatory markers between pomegranate extract and pomegranate juice versus placebo. [ Time Frame: Baseline and 12 weeks ]
    Utilization of a two-sample t-test to compare the change in between the three groups


Secondary Outcome Measures :
  1. Linear mixed effects models to evaluate effect of treatment of time trends and demographic covariates [ Time Frame: Baseline and 12 weeks ]
    Correlation between outcomes measures (e.g. between acne lesion count and skin microbiota) with mixed effects models



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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258776


Locations
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United States, California
UCLA Center for Human Nutrition
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Zhaoping Li, M.D., Ph.D. UCLA Department of Medicine

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Responsible Party: Zhaoping Li, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02258776     History of Changes
Other Study ID Numbers: PomSkin 14-001011
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes