Effects of Mango Intake on Skin Health and Gut Microbiome Changes in Postmenopausal Women

Study Overview
=================
Brief 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.

Official Title
-----------------
Effects of Mango Intake on Skin Health and Gut Microbiome Changes in Postmenopausal Women

Conditions
-----------------
Photoaging

Intervention / Treatment
-----------------
* Other: Food


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Healthy postmenopausal women aged 50 - 70, Fitzpatrick skin type I, II, or III
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mango<br>85g mango, 4x/week | Other: Food<br>* 85g mango, 4x/week<br>|
| No Intervention: No Mango<br>No mango intake | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkles | Wrinkle score measured by Facial Image Analysis System | week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial Hydration | Moisture measured by MoistureMeterSC | week 20 | 
| Facial Redness | Redness measured by Facial Image Analysis System | week 20 | 
| Facial Elasticity | measured by Cutometer | week 20 | 
| Gut microbiome | analyze for changes in gut microbiome diversity measures (Shannon Diversity) | week 20 | 
| Gut microbiome | Analyze for the relative abundance of short chain fatty acid producing bacteria | week 20 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wrinkles, Polyphenols, Vitamins