The Effect of a Healthy Snack on Radiance, Aging and Inflammation of the Skin (AlmondSkin)

April 16, 2020 updated by: Zhaoping Li, University of California, Los Angeles

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Center for Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Almonds
Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks
Other: Almond
Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks
Active Comparator: Pretzels
Consume 2 oz. serving pretzels (216 calories) daily for 12 weeks
Other: Pretzel
Consume 2 oz. serving of pretzels (216 calories) daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
UV radiation sensitivity
Time Frame: 12 weeks
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.
12 weeks
Skin aging (elasticity, sebum, and hydration/moisture)
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Almond Board of California

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhaoping Li, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-002001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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