Skin LaxityAlmondSkinNCT04352504
The Effect of a Healthy Snack on Radiance, Aging and Inflammation of the Skin
A study testing Almond and Pretzel in people with Skin Laxity, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The anti-oxidative and anti-inflammatory effects of polyphenolic compounds of almonds have been reported in limited animal studies and may have the potential to improve skin radiance. However, the skin related beneficial properties of almonds have not been investigated in humans. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Almond and Pretzel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2019to 23 Jan 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Asian females age 18-50 years' old (inclusive)
- Typically consume low fiber/polyphenol diet (beige diet)
- In good health with a BMI of 22 to 30 kg/ m2 (inclusive)
- Non-smokers
- Fitzpatrick Skin type II-IV
- Willing to maintain their normal skin care pattern for the duration of the study
- Willing to maintain their normal diet for the duration of the study but avoid almonds and pretzels.
- Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Who cannot join
- Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols.
- Women who are pregnant, lactating or trying to become pregnant.
- Currently taking any skin related prescription medication or supplements for less than 3 months.
- Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and/or unwilling to limit intake to less than 3 drinks per week during study participation or history of alcohol dependency.
- Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- History or current diagnosis of serious medical condition such as Type I or Type II diabetes, major surgery, thyroid disease, heart problems (e.g. angina, bypass surgery, myocardial infarction, etc.), presence of implanted cardiac defibrillator or pacemaker, uncontrolled hypertension/high blood pressure, gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease, inflammatory bowel disease, fatty liver or cancer.
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- Known allergy to almonds.
- Participation in another clinical trial within 30 days prior to enrollment.
- Any known clinically significant food allergy or intolerance.
- Currently taking any prescription medication or supplements for less than 3 months.
- Is unable or unwilling to comply with the study protocol.
- Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
- Received a nasally-delivered steroid, antibiotics within the past 14 days.
- Used topical antibiotic or topical steroid on the face,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, voriconazole), antihistamines (cetirizine, diphenhydramine, loratadine, promethazine, cyproheptadine)
- Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for the study
- Is unable or unwilling to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition
Los Angeles, California, 90095
About this study
Official title: Clinical Trial to Determine the Efficacy of Almonds for Skin Radiance, Inflammation and Aging in Asian Females: A Pilot Study
The anti-oxidative and anti-inflammatory effects of polyphenolic compounds of almonds have been reported in limited animal studies and may have the potential to improve skin radiance. However, the skin related beneficial properties of almonds have not been investigated in humans. This study will examine the effects of almond consumption on human skin radiance in Asian women as a pilot.
Read the detailed description
This study is a randomized, parallel group comparison of almonds vs. isocaloric pretzels 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. Subjects will consume 1.5 serving of almonds (~ 1.5 oz/d for 246kcal) or isocaloric pretzels (~ 2.0 oz/d for 216kcal) daily for 12 weeks and will undergo skin assessment at weeks 0, 4, 8 and 12. The assessments include skin radiance, sebum, and hydration/moisture. In addition the study will evaluate the effect of almond consumption on skin inflammation and aging by assessing UV-induced changes. Each group will have 20 subjects.
- Conditions
- Skin Laxity
- Being tested
- Almond, Pretzel
- Keywords
- skin, aging, almonds
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondOther
Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks
PretzelOther
Consume 2 oz. serving of pretzels (216 calories) daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Almonds | Experimental | Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks Receives: Other: Almond |
| Pretzels | Active comparator | Consume 2 oz. serving pretzels (216 calories) daily for 12 weeks Receives: Other: Pretzel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin radiance
Determine the clinical efficacy of almond consumption on skin radiance. The main criteria will be evaluated by clinical scoring using the coloring, luminosity, brightness, and transparency (C.L.B.T.TM)(18) scale and imperfections scale (dark circles, redness/rosacea, spots, and heterogeneity). The C.L.B.T.TM methodology allows assessing different descriptors of the complexion: coloring, luminosity, brightness, and transparency of facial skin.
Measured: 12 weeks
Secondary outcomes (2)
UV radiation sensitivity
Evaluate the effect of almond consumption on skin inflammation and aging by assessing UV-induced changes. This will done using the smallest dose of UV-B radiation capable of inducing erythema (minimal erythema dose [MED]). The minimal erythema dose (MED) is determined for each subject before (week 0) and after (week 12) the intervention. Prior to testing, the skin type will be evaluated based on the Fitzpatrick Skin Type scale. Participants with Fitzpatrick skin type 2-4 were included in the study and assessed for differences in their response to UV-B induced skin changes before and after 12 weeks of study intervention.
Measured: 12 weeks
Skin aging (elasticity, sebum, and hydration/moisture)
Assess the effect of almond consumption on skin biological characteristics of elasticity, sebum, and hydration/moisture content using the Cutometer® Skin Elasticity Meter 580 (Courage and Khazaka Electronic GmbH, Cologne, Germany). 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, 6 mm in diameter, of the probe. In its standard configuration, the Cutometer is equipped with a measuring probe with a 2 mm 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. The six sites measured include: forehead, under the eye, frontal cheek, crow's foot, lateral cheek, and inner forearm.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start25 Jul 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a randomized, parallel group comparison of almonds vs. isocaloric pretzels.
- 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
- Almond Board of California
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352504
- Sponsor's protocol ID
- 18-002001
- Acronym
- AlmondSkin
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 20 Apr 2020
- 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 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Determine the Efficacy of Almonds for Skin Radiance, Inflammation and Aging in Asian Females: A Pilot Study
- ClinicalTrials.gov ID
- NCT04352504
- Acronym / sponsor ID
- AlmondSkin / 18-002001
- Conditions
- Skin Laxity
- Keywords
- skin, aging, almonds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 20 Apr 2020 (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.
The anti-oxidative and anti-inflammatory effects of polyphenolic compounds of almonds have been reported in limited animal studies and may have the potential to improve skin radiance. However, the skin related beneficial properties of almonds have not been investigated in humans. This study will examine the effects of almond consumption on human skin radiance in Asian women as a pilot.
Detailed description
This study is a randomized, parallel group comparison of almonds vs. isocaloric pretzels 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. Subjects will consume 1.5 serving of almonds (~ 1.5 oz/d for 246kcal) or isocaloric pretzels (~ 2.0 oz/d for 216kcal) daily for 12 weeks and will undergo skin assessment at weeks 0, 4, 8 and 12. The assessments include skin radiance, sebum, and hydration/moisture. In addition the study will evaluate the effect of almond consumption on skin inflammation and aging by assessing UV-induced changes. Each group will have 20 subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be a randomized, parallel group comparison of almonds vs. isocaloric pretzels.
| Arm | Type | Receives |
|---|---|---|
| Almonds | Experimental | Other: AlmondConsume 1.5 oz. serving almonds (246 calories) daily for 12 weeks |
| Pretzels | Active comparator | Other: PretzelConsume 2 oz. serving pretzels (216 calories) daily for 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy Asian females age 18-50 years' old (inclusive)
- Typically consume low fiber/polyphenol diet (beige diet)
- In good health with a BMI of 22 to 30 kg/ m2 (inclusive)
- Non-smokers
- Fitzpatrick Skin type II-IV
Key exclusion criteria (16 listed)
- Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols.
- Women who are pregnant, lactating or trying to become pregnant.
- Currently taking any skin related prescription medication or supplements for less than 3 months.
- Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and/or unwilling to limit intake to less than 3 drinks per week during study participation or history of alcohol dependency.
- Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
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 |
|---|---|---|
| AlmondConsume 1.5 oz. serving almonds (246 calories) daily for 12 weeks | Other | Almonds |
| PretzelConsume 2 oz. serving of pretzels (216 calories) daily for 12 weeks | Other | Pretzels |
Primary outcome
Skin radiance
Time frame: 12 weeks
Determine the clinical efficacy of almond consumption on skin radiance. The main criteria will be evaluated by clinical scoring using the coloring, luminosity, brightness, and transparency (C.L.B.T.TM)(18) scale and imperfections scale (dark circles, redness/rosacea, spots, and heterogeneity). The C.L.B.T.TM methodology allows assessing different descriptors of the complexion: coloring, luminosity, brightness, and transparency of facial skin.
2 secondary outcomes
UV radiation sensitivity
Time frame: 12 weeks
Skin aging (elasticity, sebum, and hydration/moisture)
Time frame: 12 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 20 Apr 2020.
- 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.
Zhaoping Li principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond and Pretzel in people with Skin Laxity, 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 8 inclusion and 16 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 20 Apr 2020. 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. 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?
Skin radiance (time frame: 12 weeks). 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 20 Apr 2020.