PhotoagingNCT04869852
Effects of Mango Intake on Skin Health and Gut Microbiome Changes in Postmenopausal Women
A study testing Food in people with Photoaging, run by Integrative Skin Science and Research.
Trial summary
Mangos are a rich source of nutrients such as carotenoids, vitamin C and fiber, as well as polyphenols and phenolic acids such as mangiferin, ellagic acid, and gallotannins. Mango extract has been reported to protect against photo-aging of the skin in an animal model exposed to UVB radiation, reducing the length of… Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2021to 30 Jun 2023
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 - 70 years old
- Postmenopausal
- Fitzpatrick skin type I, II, or III
- BMI 18.5 - 35
- Must be willing to comply with all protocol requirements
- Must be willing to have flash photo facial images taken with the imaging systems
Who cannot join
- Smokers
- Allergy to mangos
- Vegans/vegetarians
- Adults unable to consent
Trial locations and contacts
No sites are listed yet.
About this study
Mangos are a rich source of nutrients such as carotenoids, vitamin C and fiber, as well as polyphenols and phenolic acids such as mangiferin, ellagic acid, and gallotannins. Mango extract has been reported to protect against photo-aging of the skin in an animal model exposed to UVB radiation, reducing the length of wrinkles and increasing collagen bundles. Beta-carotene and other carotenoids are known to provide skin protection from sunlight, but other compounds in mangos, may also be important in reducing oxidative damage in aging skin.
We have recently completed a pilot study showing a clear trend in skin wrinkle reduction when postmenopausal women consumed 85g of Ataulfo mangos, four times per week for 16 weeks. To confirm and extend these results, a larger study is proposed.
- Conditions
- Photoaging
- Being tested
- Food
- Keywords
- Wrinkles, Polyphenols, Vitamins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
85g mango, 4x/week
| Study group | Role | What they receive |
|---|---|---|
| Mango | Experimental | 85g mango, 4x/week Receives: Other: Food |
| No Mango | No intervention | No mango intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkles
Wrinkle score measured by Facial Image Analysis System
Measured: week 20
Secondary outcomes (5)
Facial Hydration
Moisture measured by MoistureMeterSC
Measured: week 20
Facial Redness
Redness measured by Facial Image Analysis System
Measured: week 20
Facial Elasticity
measured by Cutometer
Measured: week 20
Gut microbiome
analyze for changes in gut microbiome diversity measures (Shannon Diversity)
Measured: week 20
Gut microbiome
Analyze for the relative abundance of short chain fatty acid producing bacteria
Measured: week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start30 May 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies 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
- Model description
- Healthy postmenopausal women aged 50 - 70, Fitzpatrick skin type I, II, or III
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Mango Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869852
- Sponsor's protocol ID
- MANGO_02
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mango Intake on Skin Health and Gut Microbiome Changes in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04869852
- Acronym / sponsor ID
- MANGO_02
- Conditions
- Photoaging
- Keywords
- Wrinkles, Polyphenols, Vitamins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- National Mango Board
- Study start
- 30 May 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 3 May 2021 (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.
Mangos are a rich source of nutrients such as carotenoids, vitamin C and fiber, as well as polyphenols and phenolic acids such as mangiferin, ellagic acid, and gallotannins. Mango extract has been reported to protect against photo-aging of the skin in an animal model exposed to UVB radiation, reducing the length of wrinkles and increasing collagen bundles. Beta-carotene and other carotenoids are known to provide skin protection from sunlight, but other compounds in mangos, may also be important in reducing oxidative damage in aging skin.
We have recently completed a pilot study showing a clear trend in skin wrinkle reduction when postmenopausal women consumed 85g of Ataulfo mangos, four times per week for 16 weeks. To confirm and extend these results, a larger study is proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthy postmenopausal women aged 50 - 70, Fitzpatrick skin type I, II, or III
| Arm | Type | Receives |
|---|---|---|
| Mango | Experimental | Other: Food85g mango, 4x/week |
| No Mango | No intervention | –No mango intake |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50 - 70 years old
- Postmenopausal
- Fitzpatrick skin type I, II, or III
- BMI 18.5 - 35
- Must be willing to comply with all protocol requirements
Key exclusion criteria (4 listed)
- Smokers
- Allergy to mangos
- Vegans/vegetarians
- Adults unable to consent
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 |
|---|---|---|
| Food85g mango, 4x/week | Other | Mango |
Primary outcome
Wrinkles
Time frame: week 20
Wrinkle score measured by Facial Image Analysis System
5 secondary outcomes
Facial Hydration
Time frame: week 20
Facial Redness
Time frame: week 20
Facial Elasticity
Time frame: week 20
Gut microbiome
Time frame: week 20
Gut microbiome
Time frame: week 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Food in people with Photoaging, run by Integrative Skin Science and Research.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja Sivamani, MD, MS, AP (9165241216, raja.sivamani@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrinkles (time frame: week 20). 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 20 May 2021.