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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

Tracking Information
First Submitted Date  ICMJE July 3, 2018
First Posted Date  ICMJE July 18, 2018
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE July 17, 2018
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • Sebum [ Time Frame: 0, 8, 16, weeks ]
    Sebum will be collected with sebutapes from the face and stored for possible further analysis.
  • Plasma carotenoid [ Time Frame: 0, 8, 16 weeks. ]
    Plasma samples will be collected and stored at -80C for possible further analysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Mango Intake of Skin Health in Postmenopausal Women
Official Title  ICMJE Influence of Mango Intake on Skin Health in Postmenopausal Women
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Wrinkle
  • Skin Red
Intervention  ICMJE Other: 16 weeks mango intake
Participants will be provided fresh frozen Ataulfo mangoes.
Study Arms  ICMJE
  • Experimental: High mango group
    250g (1.5 cup) of mango intake per day, 4 days a week for 16 weeks
    Intervention: Other: 16 weeks mango intake
  • Low mango group
    85g (0.5 cup) of mango intake per day, 4 days a week for 16 weeks
    Intervention: Other: 16 weeks mango intake
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2018)
40
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03590756
Other Study ID Numbers  ICMJE 1185928
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE National Mango Board
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP