Clinical trial NCT05102604: The Effect of Avocado vs. Usual Diet on Skin Aging
Official title: A Pilot Study to Determine the Effect of Avocado Consumption on Skin Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Inflammation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Hass Avocado Board
First posted: 2021-11-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two equally sized groups.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Female subjects
* Increased waist circumference defined as ≥35 inches for women (NCEP ATP III 2005)
* Women
* At least 25 years old at screening
* Not currently eating more than 2 avocados per month (habitual intake in U.S.)
* Non-smokers
* Fitzpatrick Skin type II-IV
* Willing to maintain their normal skin care pattern for the duration of the study (avoiding excessive sun, not beginning new skin treatments)
* Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment

Exclusion Criteria:

* Does not eat avocados
* Sensitive / allergic to avocados
* Allergies to latex or oral allergy syndrome
* Not willing or unable to undergo MRI scans
* Unstable medical condition such as on dialysis for renal disease, cardiac, gastrointestinal, or hepatic disease, cancer (non-melanoma skin cancer \>5 years ago acceptable, any cancer site \>10yrs without recurrence).
* Pregnant, lactating, intention of pregnancy
* Lost or gained 10 lbs of body weight in last year
* Following restricted or weight loss dietary patterns
* Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
* Unstable anti-anxiety / anti-depressive / anti-psychotic medication use defined as dose change within last 6 months
* Currently taking any prescription medications that increase the risk of photosensitivity or history of taking such medications in the less than 3 months (e.g. alpha-hydroxy acids in cosmetics, antibiotics (ciprofloxacin, doxycycline, levofloxacin, ofloxacin, tetracycline, trimethoprim), antifungals (flucytosine, griseofulvin, voricanozole), antihistamines (cetirizine, diphenhydramine, loratadine, promethazine, cyproheptadine), Accutane
* Oral steroid use within the last 6 months longer than 7 days
* Elevated alcohol intake (7+ drinks/week females; 14+ drinks/week males)
* Participation in another clinical intervention trial within 30 days of baseline

Primary outcomes:
measure: Minimal erythema
timeFrame: 16 weeks
measure: Skin Elasticity
timeFrame: 16 weeks
Secondary outcomes:
measure: Skin Type Classification
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition
state: California
Study officials:
References: