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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04869852
Other study ID # MANGO_02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 30, 2021
Est. completion date June 30, 2023

Study information

Verified date May 2021
Source Integrative Skin Science and Research
Contact Raja Sivamani, MD, MS, AP
Phone 9165241216
Email raja.sivamani@integrativeskinresearch.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date June 30, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Smokers - Allergy to mangos - Vegans/vegetarians - Adults unable to consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Food
85g mango, 4x/week

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Integrative Skin Science and Research National Mango Board

Outcome

Type Measure Description Time frame Safety issue
Primary Wrinkles Wrinkle score measured by Facial Image Analysis System week 20
Secondary Facial Hydration Moisture measured by MoistureMeterSC week 20
Secondary Facial Redness Redness measured by Facial Image Analysis System week 20
Secondary Facial Elasticity measured by Cutometer week 20
Secondary Gut microbiome analyze for changes in gut microbiome diversity measures (Shannon Diversity) week 20
Secondary Gut microbiome Analyze for the relative abundance of short chain fatty acid producing bacteria week 20
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