An interventional study of Avocado and Habitual diet in Skin Inflammation, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to female participants aged 25 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Prevention
This clinical trial aims to assess the effect of providing one avocado per day on skin health in comparison with a control group maintaining their habitual diets. Participants will be randomly assigned to one of two equally sized groups. Both groups will be instructed to continue to follow their habitual diet but the intervention group will receive one avocado per day. Participants will be followed for outcomes for a four-month period.
This study will be a randomized, parallel group comparison of daily avocado consumption vs. habitual diet. The study will be carried out in accordance with the guidelines of the Human Subjects Protection Committee of the University of California, Los Angeles. All subjects will give written informed consent before the study begins.
At screening, informed consent and HIPAA authorization will be reviewed and signed. A medical history will be obtained. Enrollment will be reviewed by the study physician according to inclusion and exclusion criteria. Skin type and response to UVB will be assessed.
At baseline, participants will undergo skin testing. Subjects will consume 1 avocado a day (Hass Avocado) or maintain habitual diet (up to 2 avocados/month) daily for 16 weeks. Skin will be assessed at weeks 0, 8 and 16. Each group will have 20 subjects as calculated by power analysis. Two additional subjects for each group will be recruited for possible dropouts and a total of 22 subjects will be recruited for each group.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 40 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Exclusion Criteria:
one avocado per day
Other: Avocado
maintain habitual diet
Other: Habitual diet
Subjects will eat one avocado in addition to their usual diet
Subjects will eat their usual diet
Minimal erythema
Standardized inflammation will be induced by irradiating test areas on the inner arm of subjects with defined doses of narrow band ultraviolet B (NB-UVB) light delivered by the Dermalight 90 handheld device (National Biological).
Time frame: 16 weeks
Skin Elasticity
The Cutometer measures the vertical deformation of the skin in millimeters when the skin is pulled by means of a controlled vacuum into the circular aperture, 6mm in diameter, of the probe. In its standard configuration, the Cutometer is equipped with a measuring probe with a 2mm aperture because the device is originally designed to measure only the elastic properties of the epidermis. Skin hydration will measured using the moisture/hydration probe that attaches to the Cutometer. We will measure six sites: forehead, under the eye, frontal cheek, crow's foot, lateral cheek, and inner forearm.
Time frame: 16 weeks
Skin Type Classification
Developed in 1975, the system classifies skin type according to the amount of pigment the skin has and the skin's reaction to sun exposure. This information can help predict your overall risk of sun damage and skin cancer.
Time frame: 16 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles