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| Name | Class |
|---|---|
| Verdure Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assigned Interventions | Active Comparator | oral active pomella taken by mouth once per day |
|
| Placebo | Placebo Comparator | oral placebo taken by mouth once per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Shift in Gut Microbiome Diversity | Stool is collected and analyzed for species of bacteria through nucleic acid sequencing. | 4 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skin Microbiome Diversity | The alpha and beta diversity of facial skin microbiome collections will be evaluated | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
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| 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 |
|
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 |