WrinkleMSSNCT03590756
Influence of Mango Intake of Skin Health in Postmenopausal Women
A study testing 16 weeks mango intake in people with Wrinkle and Skin Red, run by University of California, Davis at 1 site in United States.
Trial summary
This study aims to investigate the effects on 16 weeks of mango intake on skin health in postmenopausal women. Half of the participants will receive 85g portions of mangoes while the other half receive 250g portions of mangos. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- What is being tested?
- 16 weeks mango intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2018to 31 May 2019
- 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
- Postmenopausal
- Fitzpatrick skin type I and II
- BMI 18.5 - 35.0 kg/m2
- Normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician
Who cannot join
- Allergic to mangoes
- Fruit consumption of 2 or more cups per day
- Vegetable consumption of 3 or more cups per day for females
- Fruit juice consumption of more than 1 cup per day
- Self-reported malabsorption
- Currently taking regular prescription drugs i.e. statins, thyroid, anti-inflammatory drugs
Show all 11Show fewer
- Had any medical or cosmetic procedures such as laser resurfacing or plastic surgery to the face within the last 6 months, including botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
- Autoimmune photosensitive condition or known genetic condition with a deficiency in collagen production (such as Ehler-Danlos)
- Smoking (current smoker, smoked within the past year, former smokers with greater than a 20 pack-year history of smoking within the past 20 years.
- Indications of substance or alcohol abuse
- Unwillingness to discontinue high antioxidant supplements during washout and interventions
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Influence of Mango Intake on Skin Health in Postmenopausal Women
This study aims to investigate the effects on 16 weeks of mango intake on skin health in postmenopausal women. Half of the participants will receive 85g portions of mangoes while the other half receive 250g portions of mangos. Participants will be instructed to consume the specific portion 4 times a week, for a total duration of 16 weeks.
Read the detailed description
Mangoes are rich in carotenoids, flavonoids, vitamins and other active phytochemicals such as resistant starches. Although a role of mangoes in skin health has long been advocated in traditional medicine, little scientific research has been conducted.
We hypothesize that 85g (0.5 cups) of mango intake for 16 weeks will have minimal impact on skin health, while 250g (1.5 cups) of mango intake will produce significant benefits.
- Being tested
- 16 weeks mango intake
- Keywords
- Skin Health, Skin Wrinkle, Skin Redness, Carotenoid, Mango
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16 weeks mango intakeOther
Participants will be provided fresh frozen Ataulfo mangoes.
| Study group | Role | What they receive |
|---|---|---|
| High mango group | Experimental | 250g (1.5 cup) of mango intake per day, 4 days a week for 16 weeks Receives: Other: 16 weeks mango intake |
| Low mango group | Other | 85g (0.5 cup) of mango intake per day, 4 days a week for 16 weeks Receives: Other: 16 weeks mango intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Wrinkle Depth and Redness
Using a skin camera from BrighTex Bio-Photonics to measure change in skin wrinkle depth and redness within a period of 16 weeks.
Measured: 0, 8, and 16 week
Skin carotenoid
Using a skin photometer (Veggie Meter) to measure change in skin carotenoid within a period of 16 weeks.
Measured: 0, 4, 8, 12, and 16 weeks
Secondary outcomes (2)
Sebum
Sebum will be collected with sebutapes from the face and stored for possible further analysis.
Measured: 0, 8, 16, weeks
Plasma carotenoid
Plasma samples will be collected and stored at -80C for possible further analysis
Measured: 0, 8, 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start17 Jul 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Mango Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590756
- Sponsor's protocol ID
- 1185928
- Acronym
- MSS
- Status last verified
- Oct 2019
- First submitted
- 3 Jul 2018
- Last updated
- 14 Oct 2019
- Results posted
- 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 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Mango Intake on Skin Health in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03590756
- Acronym / sponsor ID
- MSS / 1185928
- Keywords
- Skin Health, Skin Wrinkle, Skin Redness, Carotenoid, Mango
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Mango Board
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 18 Jul 2018 (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.
This study aims to investigate the effects on 16 weeks of mango intake on skin health in postmenopausal women. Half of the participants will receive 85g portions of mangoes while the other half receive 250g portions of mangos. Participants will be instructed to consume the specific portion 4 times a week, for a total duration of 16 weeks.
Detailed description
Mangoes are rich in carotenoids, flavonoids, vitamins and other active phytochemicals such as resistant starches. Although a role of mangoes in skin health has long been advocated in traditional medicine, little scientific research has been conducted.
We hypothesize that 85g (0.5 cups) of mango intake for 16 weeks will have minimal impact on skin health, while 250g (1.5 cups) of mango intake will produce significant benefits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High mango group | Experimental | Other: 16 weeks mango intake250g (1.5 cup) of mango intake per day, 4 days a week for 16 weeks |
| Low mango group | Other | Other: 16 weeks mango intake85g (0.5 cup) of mango intake per day, 4 days a week for 16 weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal
- Fitzpatrick skin type I and II
- BMI 18.5 - 35.0 kg/m2
- Normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician
Key exclusion criteria (11 listed)
- Allergic to mangoes
- Fruit consumption of 2 or more cups per day
- Vegetable consumption of 3 or more cups per day for females
- Fruit juice consumption of more than 1 cup per day
- Self-reported malabsorption
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 |
|---|---|---|
| 16 weeks mango intakeParticipants will be provided fresh frozen Ataulfo mangoes. | Other | High mango group, Low mango group |
Primary outcome
Skin Wrinkle Depth and Redness
Time frame: 0, 8, and 16 week
Using a skin camera from BrighTex Bio-Photonics to measure change in skin wrinkle depth and redness within a period of 16 weeks.
Skin carotenoid
Time frame: 0, 4, 8, 12, and 16 weeks
Using a skin photometer (Veggie Meter) to measure change in skin carotenoid within a period of 16 weeks.
2 secondary outcomes
Sebum
Time frame: 0, 8, 16, weeks
Plasma carotenoid
Time frame: 0, 8, 16 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 14 Oct 2019.
- 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.
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 16 weeks mango intake in people with Wrinkle and Skin Red, run by University of California, Davis 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 11 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 14 Oct 2019. 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. 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?
Skin Wrinkle Depth and Redness (time frame: 0, 8, and 16 week). The study lists 2 primary outcomes in all. 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 14 Oct 2019.