Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-01-01
2020-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Avocado
one avocado per day
Avocado
Subjects will eat one avocado in addition to their usual diet
Habitual Diet
maintain habitual diet
Habitual diet
Subjects will eat their usual diet
Interventions
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Avocado
Subjects will eat one avocado in addition to their usual diet
Habitual diet
Subjects will eat their usual diet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
90 Years
FEMALE
Yes
Sponsors
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Hass Avocado Board
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Zhaoping Li
Principal Investigator
Locations
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UCLA Center for Human Nutrition
Los Angeles, California, United States
Countries
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Other Identifiers
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19-001834
Identifier Type: -
Identifier Source: org_study_id