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

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 Overview

• Status: Not yet recruiting
• Conditions: Photoaging
• Intervention / Treatment: Other: Food

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raja Sivamani, MD, MS, AP; Phone Number: 9165241216; Email: raja.sivamani@integrativeskinresearch.com
• Study Contact Backup: Name: Vivien Fam, PhD, RDN; Phone Number: 5307605968; Email: vivien@integrativeskinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mango; 85g mango, 4x/week	Other: Food; 85g mango, 4x/week
No Intervention: No Mango; 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

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: National Mango Board

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Polyphenols; Wrinkles; Vitamins
• Other Study ID Numbers: MANGO_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No