Oral Pomegranate Extract on the Microbiome and Skin Biophysical Properties

Human Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596722
• Other study ID #: POM01
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: March 24, 2021

Study information

• Verified date: April 2021
• Source: Integrative Skin Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 24, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Microbiome

Intervention

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

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

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Verdure Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Skin Microbiome Diversity	The alpha and beta diversity of facial skin microbiome collections will be evaluated	4 weeks
Primary	Shift in Gut Microbiome Diversity	Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.	4 weeks
Secondary	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
Secondary	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
Secondary	Change in Skin Brightness - Device based	SkinColorCatch colorimeter RGB range: 25-246 per channel	4 weeks
Secondary	Change in Sebum Excretion Rate	Delfin Sebumeter: 0-150 micrograms/cm^2	4 weeks
Secondary	Change in Transepidermal Water Loss	Delfin Vapometer 0-300g/m^2h; Delfin MoisturemeterSC 0-150	4 weeks
Secondary	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
Secondary	Shift in the Blood Short Chain Fatty Acid Levels	Short chain fatty acids are measured from a venipuncture	4 weeks
Secondary	Change in skin brightness - image based	BTBP Clarity Mini 3D Camera	4 weeks