NCT02258776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2017

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

September 26, 2014

Last Update Submit

February 27, 2017

Conditions

Skin Photoaging, Inflammation and Skin Pathogenic Bacteria

Outcome Measures

Primary Outcomes (1)

  • Change in inflammatory markers between pomegranate extract and pomegranate juice versus placebo.

    Utilization of a two-sample t-test to compare the change in between the three groups

    Baseline and 12 weeks

Secondary Outcomes (1)

  • Linear mixed effects models to evaluate effect of treatment of time trends and demographic covariates

    Baseline and 12 weeks

Study Arms (3)

Pomegranate Extract

ACTIVE COMPARATOR

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 Juice

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Pomegranate ExtractDIETARY_SUPPLEMENT

Pomegranate extract 1000mg will be taken 1/day for 12 weeks.

Pomegranate Extract
Pomegranate JuiceDIETARY_SUPPLEMENT

Pomegranate juice 8oz will be consumed 1/day for 12 weeks.

Pomegranate Juice
PlaceboDIETARY_SUPPLEMENT

Placebo will be taken 1/day for 12 weeks.

Placebo

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 30-45 years or older, female and any racial/ethnic group
  • Subjects must understand and sign the informed consent prior to participation
  • Subjects must be in generally good health
  • Subjects must be able and willing to comply with the requirements of the protocol.

You may not qualify if:

  • Oral or topical retinoid use within twelve months of entry into the study
  • Non-compliant subjects
  • Taking any antibiotics or other medication or dietary supplements regularly
  • Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for the study
  • Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
  • Allergic to pomegranate products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

pomegranate fruit rind

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhaoping Li, M.D., Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 26, 2014

First Posted

October 7, 2014

Study Start

October 1, 2015

Primary Completion

February 27, 2017

Study Completion

February 27, 2017

Last Updated

March 1, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)