Skin InflammationAvoSkinNCT05102604
The Effect of Avocado vs. Usual Diet on Skin Aging
A study testing Avocado and Habitual diet in people with Skin Inflammation, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Inflammation
- What is being tested?
- Avocado and Habitual diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition
Los Angeles, California, 90024
About this study
Official title: A Pilot Study to Determine the Effect of Avocado Consumption on Skin Aging
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.
Read the 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.
- Conditions
- Skin Inflammation
- Being tested
- Avocado, Habitual diet
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvocadoOther
Subjects will eat one avocado in addition to their usual diet
Habitual dietOther
Subjects will eat their usual diet
| Study group | Role | What they receive |
|---|---|---|
| Avocado | Active comparator | one avocado per day Receives: Other: Avocado |
| Habitual Diet | Placebo comparator | maintain habitual diet Receives: Other: Habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 16 weeks
Secondary outcomes (1)
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Jan 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InflammationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two equally sized groups.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Hass Avocado Board
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102604
- Sponsor's protocol ID
- 19-001834
- Acronym
- AvoSkin
- Status last verified
- Oct 2021
- First submitted
- 24 Aug 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Effect of Avocado Consumption on Skin Aging
- ClinicalTrials.gov ID
- NCT05102604
- Acronym / sponsor ID
- AvoSkin / 19-001834
- Conditions
- Skin Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Hass Avocado Board
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two equally sized groups.
| Arm | Type | Receives |
|---|---|---|
| Avocado | Active comparator | Other: Avocadoone avocado per day |
| Habitual Diet | Placebo comparator | Other: Habitual dietmaintain habitual diet |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.)
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvocadoSubjects will eat one avocado in addition to their usual diet | Other | Avocado |
| Habitual dietSubjects will eat their usual diet | Other | Habitual Diet |
Primary outcome
Minimal erythema
Time frame: 16 weeks
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
Time frame: 16 weeks
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.
1 secondary outcome
Skin Type Classification
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avocado and Habitual diet in people with Skin Inflammation, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal erythema (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.