search
Back to results

Influence of Mango Intake of Skin Health in Postmenopausal Women (MSS)

Primary Purpose

Wrinkle, Skin Red

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
16 weeks mango intake
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Wrinkle focused on measuring Skin Health, Skin Wrinkle, Skin Redness, Carotenoid, Mango

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ragle Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

High mango group

Low mango group

Arm Description

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

85g (0.5 cup) of mango intake per day, 4 days a week for 16 weeks

Outcomes

Primary Outcome Measures

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.
Skin carotenoid
Using a skin photometer (Veggie Meter) to measure change in skin carotenoid within a period of 16 weeks.

Secondary Outcome Measures

Sebum
Sebum will be collected with sebutapes from the face and stored for possible further analysis.
Plasma carotenoid
Plasma samples will be collected and stored at -80C for possible further analysis

Full Information

First Posted
July 3, 2018
Last Updated
October 10, 2019
Sponsor
University of California, Davis
Collaborators
National Mango Board
search

1. Study Identification

Unique Protocol Identification Number
NCT03590756
Brief Title
Influence of Mango Intake of Skin Health in Postmenopausal Women
Acronym
MSS
Official Title
Influence of Mango Intake on Skin Health in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Mango Board

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Mangoes are rich in carotenoids, flavonoids, vitamins and other active phytochemicals such as resistant starches. Although a role of mangoes in skin health has long been advocated in traditional medicine, little scientific research has been conducted. We hypothesize that 85g (0.5 cups) of mango intake for 16 weeks will have minimal impact on skin health, while 250g (1.5 cups) of mango intake will produce significant benefits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrinkle, Skin Red
Keywords
Skin Health, Skin Wrinkle, Skin Redness, Carotenoid, Mango

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High mango group
Arm Type
Experimental
Arm Description
250g (1.5 cup) of mango intake per day, 4 days a week for 16 weeks
Arm Title
Low mango group
Arm Type
Other
Arm Description
85g (0.5 cup) of mango intake per day, 4 days a week for 16 weeks
Intervention Type
Other
Intervention Name(s)
16 weeks mango intake
Intervention Description
Participants will be provided fresh frozen Ataulfo mangoes.
Primary Outcome Measure Information:
Title
Skin Wrinkle Depth and Redness
Description
Using a skin camera from BrighTex Bio-Photonics to measure change in skin wrinkle depth and redness within a period of 16 weeks.
Time Frame
0, 8, and 16 week
Title
Skin carotenoid
Description
Using a skin photometer (Veggie Meter) to measure change in skin carotenoid within a period of 16 weeks.
Time Frame
0, 4, 8, 12, and 16 weeks
Secondary Outcome Measure Information:
Title
Sebum
Description
Sebum will be collected with sebutapes from the face and stored for possible further analysis.
Time Frame
0, 8, 16, weeks
Title
Plasma carotenoid
Description
Plasma samples will be collected and stored at -80C for possible further analysis
Time Frame
0, 8, 16 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Ragle Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Influence of Mango Intake of Skin Health in Postmenopausal Women

We'll reach out to this number within 24 hrs