The Effect of a Healthy Snack on Radiance, Aging and Inflammation of the Skin (AlmondSkin)
Primary Purpose
Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Almond
Pretzel
Sponsored by

About this trial
This is an interventional other trial for Skin Laxity focused on measuring skin, aging, almonds
Eligibility Criteria
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.
Sites / Locations
- UCLA Center for Human Nutrition
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Almonds
Pretzels
Arm Description
Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks
Consume 2 oz. serving pretzels (216 calories) daily for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04352504
First Posted
April 9, 2020
Last Updated
April 16, 2020
Sponsor
University of California, Los Angeles
Collaborators
Almond Board of California
1. Study Identification
Unique Protocol Identification Number
NCT04352504
Brief Title
The Effect of a Healthy Snack on Radiance, Aging and Inflammation of the Skin
Acronym
AlmondSkin
Official Title
Clinical Trial to Determine the Efficacy of Almonds for Skin Radiance, Inflammation and Aging in Asian Females: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Almond Board of California
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
skin, aging, almonds
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a randomized, parallel group comparison of almonds vs. isocaloric pretzels.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Almonds
Arm Type
Experimental
Arm Description
Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks
Arm Title
Pretzels
Arm Type
Active Comparator
Arm Description
Consume 2 oz. serving pretzels (216 calories) daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Almond
Intervention Description
Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Pretzel
Intervention Description
Consume 2 oz. serving of pretzels (216 calories) daily for 12 weeks
Primary Outcome Measure Information:
Title
Skin radiance
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
UV radiation sensitivity
Description
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.
Time Frame
12 weeks
Title
Skin aging (elasticity, sebum, and hydration/moisture)
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoping Li
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Human Nutrition
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of a Healthy Snack on Radiance, Aging and Inflammation of the Skin
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