NCT04869852

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

May 30, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

April 29, 2021

Last Update Submit

May 18, 2021

Conditions

Photoaging

Keywords

WrinklesPolyphenolsVitamins

Outcome Measures

Primary Outcomes (1)

  • Wrinkles

    Wrinkle score measured by Facial Image Analysis System

    week 20

Secondary Outcomes (5)

  • Facial Hydration

    week 20

  • Facial Redness

    week 20

  • Facial Elasticity

    week 20

  • Gut microbiome

    week 20

  • Gut microbiome

    week 20

Study Arms (2)

Mango

EXPERIMENTAL

85g mango, 4x/week

Other: Food

No Mango

NO INTERVENTION

No mango intake

Interventions

FoodOTHER

85g mango, 4x/week

Mango

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smokers
  • Allergy to mangos
  • Vegans/vegetarians
  • Adults unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Raja Sivamani, MD, MS, AP

CONTACT

9165241216raja.sivamani@integrativeskinresearch.com

Vivien Fam, PhD, RDN

CONTACT

5307605968vivien@integrativeskinresearch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Healthy postmenopausal women aged 50 - 70, Fitzpatrick skin type I, II, or III
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 3, 2021

Study Start

May 30, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share