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The Effect of Avocado vs. Usual Diet on Skin Aging (AvoSkin)

Primary Purpose

Skin Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avocado
Habitual diet
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Inflammation

Eligibility Criteria

25 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Center for Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Avocado

Habitual Diet

Arm Description

one avocado per day

maintain habitual diet

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 24, 2021
Last Updated
October 20, 2021
Sponsor
University of California, Los Angeles
Collaborators
Hass Avocado Board
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1. Study Identification

Unique Protocol Identification Number
NCT05102604
Brief Title
The Effect of Avocado vs. Usual Diet on Skin Aging
Acronym
AvoSkin
Official Title
A Pilot Study to Determine the Effect of Avocado Consumption on Skin Aging
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Hass Avocado Board

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of two equally sized groups.
Masking
None (Open Label)
Masking Description
Both groups will be instructed to continue to follow their habitual diet but the intervention group will receive one avocado per day
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avocado
Arm Type
Active Comparator
Arm Description
one avocado per day
Arm Title
Habitual Diet
Arm Type
Placebo Comparator
Arm Description
maintain habitual diet
Intervention Type
Other
Intervention Name(s)
Avocado
Intervention Description
Subjects will eat one avocado in addition to their usual diet
Intervention Type
Other
Intervention Name(s)
Habitual diet
Intervention Description
Subjects will eat their usual diet
Primary Outcome Measure Information:
Title
Minimal erythema
Description
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
Title
Skin Elasticity
Description
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
Secondary Outcome Measure Information:
Title
Skin Type Classification
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
UCLA Center for Human Nutrition
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Avocado vs. Usual Diet on Skin Aging

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