Oral Pomegranate Extract on the Microbiome and Skin Biophysical Properties

NCT04596722 | Completed

• 1 other identifier: POM01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Pomegranate extract (Pomella) is well known for its antioxidant properties due to its phenolic compounds. It has also been shown to increase the amount of short chain fatty acid producing Lactobacillus and Bifidobacteria genera. Short chain fatty acids are thought to have an anti-inflammatory effect on the sebaceous glands. Previous studies have concluded that pomegranate extract may act as a prebiotic in the body and subsequently increasing the gastrointestinal microbial diversity and by producing short chain fatty acids that may have systemic beneficial effects especially on the skin. Therefore, the aim of this study is to assess how Pomella alters the gut microbiome and the blood level of short chain fatty acids in healthy subjects.

Conditions

Human Microbiome

Keywords

gut microbiome; polyphenols; skin; dermatology; pomegranate extract; punicalagins

Outcome Measures

Primary Outcomes (1)

• Shift in Gut Microbiome Diversity

  Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.

  4 weeks

Secondary Outcomes (8)

• Gut Microbiome Changes- Abundance and Presence of Short Chain Fatty Acid producing Bacteria

  4 weeks

• Safety Assessment for GI Distress

  4 weeks

• Change in Skin Brightness - Device based

  4 weeks

• Change in Sebum Excretion Rate

  4 weeks

• Change in Transepidermal Water Loss

  4 weeks

Other Outcomes (1)

• Change in Skin Microbiome Diversity

  4 weeks

Study Arms (2)

Assigned Interventions

ACTIVE COMPARATOR

oral active pomella taken by mouth once per day

Dietary Supplement: Pomella

Placebo

PLACEBO COMPARATOR

oral placebo taken by mouth once per day

Other: Placebo

Interventions

Pomella DIETARY_SUPPLEMENT

Pomella® Pomegranate Whole Fruit Extract containing 75 mg punicalagin in white/white HPMC size "1" capsules packed in white color HDPE bottle of 30 counts

Assigned Interventions

Placebo OTHER

White/white HPMC size "1" capsules each containing 97.67% Maltodextrin, 0.10% Tartrazine color, 0.22% Brown Color, 2.01% Aerosil packed in white color HDPE bottle of 30 counts

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged 25-55
• Must be willing to comply with all protocol requirements
• Must be willing to have flash photo facial images taken with the imaging systems
• Males must be willing to shave any facial hair

You may not qualify if:

• Any systemic or antibiotics (injected or oral) within 6 months of starting study
• Any topical antibiotic or benzoyl peroxide within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or benzoyl peroxide ingredient.
• No intake of alcohol or tea throughout the duration of the study.
• No more than 1 8 oz cup of coffee per week throughout the duration of the study.
• No more than 1 cup of berries (strawberries, blueberries, raspberries, blackberries, etc.) per week throughout the duration of the study.
• No intake of pomegranate, or pomegranate-containing drinks throughout the duration of the study.
• No intake of chocolate (in any form) throughout the duration of the study.
• No more than 1 cup of fermented dairy products per week throughout the duration of the study.
• Any oral probiotic or prebiotic supplementation within past 1 month
• Subjects must have no history of malignancy or cancer or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis)
• Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results
• Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating.
• Is participating in a concurrent clinical research study or has participated in an acne or other facial study at this or any other facility in the past 4 weeks
• Those with BMI higher than 35 kg/m²
• Commencement of a new diet (such as the ketogenic diet) or supplements within the 1 month prior to initiating participation, at the discretion of the investigator.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Verdure Sciences: collaborator

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 22, 2020
• Study Start: November 9, 2020
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

US (1)