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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03590756
Other study ID # 1185928
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 17, 2018
Est. completion date May 31, 2019

Study information

Verified date October 2019
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
16 weeks mango intake
Participants will be provided fresh frozen Ataulfo mangoes.

Locations

Country Name City State
United States Ragle Human Nutrition Research Center Davis California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis National Mango Board

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Sebum Sebum will be collected with sebutapes from the face and stored for possible further analysis. 0, 8, 16, weeks
Secondary Plasma carotenoid Plasma samples will be collected and stored at -80C for possible further analysis 0, 8, 16 weeks.
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