NCT03590756

Brief 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. Participants will be instructed to consume the specific portion 4 times a week, for a total duration of 16 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

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

July 3, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

July 17, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

July 3, 2018

Last Update Submit

October 10, 2019

Conditions

Keywords

Skin HealthSkin WrinkleSkin RednessCarotenoidMango

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    0, 4, 8, 12, and 16 weeks

Secondary Outcomes (2)

  • Sebum

    0, 8, 16, weeks

  • Plasma carotenoid

    0, 8, 16 weeks.

Study Arms (2)

High mango group

EXPERIMENTAL

250g (1.5 cup) of mango intake per day, 4 days a week for 16 weeks

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

Other: 16 weeks mango intake

Interventions

Participants will be provided fresh frozen Ataulfo mangoes.

High mango groupLow mango group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragle Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 18, 2018

Study Start

July 17, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations