Human MicrobiomeNCT04596722
Oral Pomegranate Extract on the Microbiome and Skin Biophysical Properties
A study testing Pomella in people with Human Microbiome, run by Integrative Skin Science and Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome
- What is being tested?
- Pomella
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 24 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged 25-55
- Must be willing to comply with all protocol requirements
- Must be willing to have flash photo facial images taken with the imaging systems
- Males must be willing to shave any facial hair
Who cannot join
- Any systemic or antibiotics (injected or oral) within 6 months of starting study
- 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.
- No intake of alcohol or tea throughout the duration of the study.
- No more than 1 8 oz cup of coffee per week throughout the duration of the study.
- No more than 1 cup of berries (strawberries, blueberries, raspberries, blackberries, etc.) per week throughout the duration of the study.
- No intake of pomegranate, or pomegranate-containing drinks throughout the duration of the study.
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- No intake of chocolate (in any form) throughout the duration of the study.
- No more than 1 cup of fermented dairy products per week throughout the duration of the study.
- Any oral probiotic or prebiotic supplementation within past 1 month
- 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)
- 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
- Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating.
- 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
- Those with BMI higher than 35 kg/m²
- 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.
- Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
- 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.
- Has a skin disease on face that will interfere with image collection and assessment in the opinion of the investigator
- Refusal to shave or remove facial hair that may interfere with image collection and assessment.
- 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.
- Planned vacation to sunny destination with the intention of sun tanning during the duration of the study.
- Persons who regularly undergo sauna treatments (dry or wet) or who swim daily.
- Known allergy or irritation to the supplement or facial products utilized in the study
- Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
- Prisoners
- Adults unable to consent
- Vegans
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95815
About this study
Official title: 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.
- Conditions
- Human Microbiome
- Being tested
- Pomella, Placebo
- Keywords
- gut microbiome, polyphenols, skin, dermatology, pomegranate extract, punicalagins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomellaDietary 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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Active comparator | oral active pomella taken by mouth once per day Receives: Dietary Supplement: Pomella |
| Placebo | Placebo comparator | oral placebo taken by mouth once per day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift in Gut Microbiome Diversity
Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.
Measured: 4 weeks
Secondary outcomes (8)
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.
Measured: 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)
Measured: 4 weeks
Change in Skin Brightness - Device based
SkinColorCatch colorimeter RGB range: 25-246 per channel
Measured: 4 weeks
Change in Sebum Excretion Rate
Delfin Sebumeter: 0-150 micrograms/cm^2
Measured: 4 weeks
Change in Transepidermal Water Loss
Delfin Vapometer 0-300g/m^2h; Delfin MoisturemeterSC 0-150
Measured: 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
Measured: 4 weeks
Shift in the Blood Short Chain Fatty Acid Levels
Short chain fatty acids are measured from a venipuncture
Measured: 4 weeks
Change in skin brightness - image based
BTBP Clarity Mini 3D Camera
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start9 Nov 2020
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Verdure Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596722
- Sponsor's protocol ID
- POM01
- Status last verified
- Apr 2021
- First submitted
- 9 Oct 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double-Blind Placebo Controlled Study of Oral Pomella on the Microbiome and Skin Biophysical Properties
- ClinicalTrials.gov ID
- NCT04596722
- Acronym / sponsor ID
- POM01
- Conditions
- Human Microbiome
- Keywords
- gut microbiome, polyphenols, skin, dermatology, pomegranate extract, punicalagins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Verdure Sciences
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Active comparator | Dietary Supplement: Pomellaoral active pomella taken by mouth once per day |
| Placebo | Placebo comparator | Other: Placebooral placebo taken by mouth once per day |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects aged 25-55
- Must be willing to comply with all protocol requirements
- Must be willing to have flash photo facial images taken with the imaging systems
- Males must be willing to shave any facial hair
Key exclusion criteria (27 listed)
- Any systemic or antibiotics (injected or oral) within 6 months of starting study
- 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.
- No intake of alcohol or tea throughout the duration of the study.
- No more than 1 8 oz cup of coffee per week throughout the duration of the study.
- No more than 1 cup of berries (strawberries, blueberries, raspberries, blackberries, etc.) per week throughout the duration of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PomellaPomella® Pomegranate Whole Fruit Extract containing 75 mg punicalagin in white/white HPMC size "1" capsules packed in white color HDPE bottle of 30 counts | Dietary supplement | Assigned Interventions |
| PlaceboWhite/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 | Other | Placebo |
Primary outcome
Shift in Gut Microbiome Diversity
Time frame: 4 weeks
Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.
8 secondary outcomes
Gut Microbiome Changes- Abundance and Presence of Short Chain Fatty Acid producing Bacteria
Time frame: 4 weeks
Safety Assessment for GI Distress
Time frame: 4 weeks
Change in Skin Brightness - Device based
Time frame: 4 weeks
Change in Sebum Excretion Rate
Time frame: 4 weeks
Change in Transepidermal Water Loss
Time frame: 4 weeks
Change in the Appearance of Facial Redness and Facial Skin Tone
Time frame: 4 weeks
Shift in the Blood Short Chain Fatty Acid Levels
Time frame: 4 weeks
Change in skin brightness - image based
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomella in people with Human Microbiome, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shift in Gut Microbiome Diversity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.