- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03590756
Influence of Mango Intake of Skin Health in Postmenopausal Women (MSS)
Influence of Mango Intake on Skin Health in Postmenopausal Women
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Ragle Human Nutrition Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High mango group
250g (1.5 cup) of mango intake per day, 4 days a week for 16 weeks
|
Participants will be provided fresh frozen Ataulfo mangoes.
|
|
Other: Low mango group
85g (0.5 cup) of mango intake per day, 4 days a week for 16 weeks
|
Participants will be provided fresh frozen Ataulfo mangoes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
0, 8, and 16 week
|
|
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.
|
0, 4, 8, 12, and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sebum
Time Frame: 0, 8, 16, weeks
|
Sebum will be collected with sebutapes from the face and stored for possible further analysis.
|
0, 8, 16, weeks
|
|
Plasma carotenoid
Time Frame: 0, 8, 16 weeks.
|
Plasma samples will be collected and stored at -80C for possible further analysis
|
0, 8, 16 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1185928
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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