Integrative Skin Science and Research
Sacramento, California, 95815, United States
NCT Number: NCT04596722
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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Notify Me25 year–55 year
All sexes
Interventional
Not applicable
Sacramento, California, 95815, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 4 weeks
Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.
Time frame: 4 weeks
Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.
Time frame: 4 weeks
Subjective GI based Questionnaire that will assess for distress (one combined metric that accounts for stooling, gas, and discomfort)
Time frame: 4 weeks
SkinColorCatch colorimeter RGB range: 25-246 per channel
Time frame: 4 weeks
Delfin Sebumeter: 0-150 micrograms/cm^2
Time frame: 4 weeks
Delfin Vapometer 0-300g/m^2h; Delfin MoisturemeterSC 0-150
Time frame: 4 weeks
SkinColorCatch colorimeter RGB range: 25-246 per channel; BTBP Clarity Mini 3D_V5 camera
Time frame: 4 weeks
Short chain fatty acids are measured from a venipuncture
Time frame: 4 weeks
BTBP Clarity Mini 3D Camera
Time frame: 4 weeks
The alpha and beta diversity of facial skin microbiome collections will be evaluated
Integrative Skin Science and Research
Industry
Prospective Randomized Double-Blind Placebo Controlled Study of Oral Pomella on the Microbiome and Skin Biophysical Properties
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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