NCT05102604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

August 24, 2021

Last Update Submit

October 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    16 weeks

Secondary Outcomes (1)

  • Skin Type Classification

    16 weeks

Study Arms (2)

Avocado

ACTIVE COMPARATOR

one avocado per day

Other: Avocado

Habitual Diet

PLACEBO COMPARATOR

maintain habitual diet

Other: Habitual diet

Interventions

AvocadoOTHER

Subjects will eat one avocado in addition to their usual diet

Avocado

Subjects will eat their usual diet

Habitual Diet

Eligibility Criteria

Age25 Years - 90 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Both groups will be instructed to continue to follow their habitual diet but the intervention group will receive one avocado per day
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two equally sized groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2021

First Posted

November 1, 2021

Study Start

January 1, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations