Oral Pomegranate Extract on the Microbiome and Skin Biophysical Properties

NCT ID: NCT04596722

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2021-03-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Assigned Interventions

oral active pomella taken by mouth once per day

Group Type: ACTIVE_COMPARATOR

Pomella

Intervention Type: 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

Placebo

oral placebo taken by mouth once per day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Verdure Sciences

INDUSTRY

Sponsor Role: collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Integrative Skin Science and Research

Sacramento, California, United States

Countries

United States

Other Identifiers

POM01

Identifier Type: -

Identifier Source: org_study_id