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

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ClinicalTrials.gov Identifier: NCT03590756
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
National Mango Board
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wrinkle Skin Red Other: 16 weeks mango intake Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of Mango Intake on Skin Health in Postmenopausal Women
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: High mango group
250g (1.5 cup) of mango intake per day, 4 days a week for 16 weeks
 Other: 16 weeks mango intake
Participants will be provided fresh frozen Ataulfo mangoes.
Low mango group
85g (0.5 cup) of mango intake per day, 4 days a week for 16 weeks
 Other: 16 weeks mango intake
Participants will be provided fresh frozen Ataulfo mangoes.


Outcome Measures
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Primary Outcome Measures :
  1. Skin Wrinkle Depth and Redness [ Time Frame: 0, 8, and 16 week ]
    Using a skin camera from BrighTex Bio-Photonics to measure change in skin wrinkle depth and redness within a period of 16 weeks.

  2. Skin carotenoid [ Time Frame: 0, 4, 8, 12, and 16 weeks ]
    Using a skin photometer (Veggie Meter) to measure change in skin carotenoid within a period of 16 weeks.


Secondary Outcome Measures :
  1. Sebum [ Time Frame: 0, 8, 16, weeks ]
    Sebum will be collected with sebutapes from the face and stored for possible further analysis.

  2. Plasma carotenoid [ Time Frame: 0, 8, 16 weeks. ]
    Plasma samples will be collected and stored at -80C for possible further analysis


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590756


Locations
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United States, California
Ragle Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
National Mango Board
More Information
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03590756    
Other Study ID Numbers: 1185928
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Skin Health
Skin Wrinkle
Skin Redness
Carotenoid
Mango