Oral Pomegranate Extract on the Microbiome and Skin Biophysical Properties

Prospective Randomized Double-Blind Placebo Controlled Study of Oral Pomella on the Microbiome and Skin Biophysical Properties

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.

Study Overview

• Status: Completed
• Conditions: Human Microbiome
• Intervention / Treatment: Dietary supplement: Pomella; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Any systemic or antibiotics (injected or oral) within 6 months of starting study
2. 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.
3. No intake of alcohol or tea throughout the duration of the study.
4. No more than 1 8 oz cup of coffee per week throughout the duration of the study.
5. No more than 1 cup of berries (strawberries, blueberries, raspberries, blackberries, etc.) per week throughout the duration of the study.
6. No intake of pomegranate, or pomegranate-containing drinks throughout the duration of the study.
7. No intake of chocolate (in any form) throughout the duration of the study.
8. No more than 1 cup of fermented dairy products per week throughout the duration of the study.
9. Any oral probiotic or prebiotic supplementation within past 1 month
10. 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)
11. 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
12. Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating.
13. 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
14. Those with BMI higher than 35 kg/m²
15. 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.
16. Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
17. Is participating in or has participated in a facial study at this or any other facility in the past 4 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
18. Has a skin disease on face that will interfere with image collection and assessment in the opinion of the investigator
19. Refusal to shave or remove facial hair that may interfere with image collection and assessment.
20. Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, sun tanning, or artificial tanning.
21. Planned vacation to sunny destination with the intention of sun tanning during the duration of the study.
22. Persons who regularly undergo sauna treatments (dry or wet) or who swim daily.
23. Known allergy or irritation to the supplement or facial products utilized in the study
24. Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
25. Prisoners
26. Adults unable to consent
27. Vegans

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Assigned Interventions; oral active pomella taken by mouth once per day	Dietary supplement: Pomella; 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
Placebo Comparator: Placebo; oral placebo taken by mouth once per day	Other: Placebo; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shift in Gut Microbiome Diversity	Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiome Changes- Abundance and Presence of Short Chain Fatty Acid producing Bacteria	Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.	4 weeks
Safety Assessment for GI Distress	Subjective GI based Questionnaire that will assess for distress (one combined metric that accounts for stooling, gas, and discomfort)	4 weeks
Change in Skin Brightness - Device based	SkinColorCatch colorimeter RGB range: 25-246 per channel	4 weeks
Change in Sebum Excretion Rate	Delfin Sebumeter: 0-150 micrograms/cm^2	4 weeks
Change in Transepidermal Water Loss	Delfin Vapometer 0-300g/m^2h; Delfin MoisturemeterSC 0-150	4 weeks
Change in the Appearance of Facial Redness and Facial Skin Tone	SkinColorCatch colorimeter RGB range: 25-246 per channel; BTBP Clarity Mini 3D_V5 camera	4 weeks
Shift in the Blood Short Chain Fatty Acid Levels	Short chain fatty acids are measured from a venipuncture	4 weeks
Change in skin brightness - image based	BTBP Clarity Mini 3D Camera	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Skin Microbiome Diversity	The alpha and beta diversity of facial skin microbiome collections will be evaluated	4 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Verdure Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): March 24, 2021
• Study Completion (Actual): March 24, 2021

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: skin; dermatology; gut microbiome; polyphenols; pomegranate extract; punicalagins
• Other Study ID Numbers: POM01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No