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

NCT04352504 | Completed

• 1 other identifier: 18-002001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Laxity

Keywords

skin; aging; almonds

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• UV radiation sensitivity

  12 weeks

• Skin aging (elasticity, sebum, and hydration/moisture)

  12 weeks

Study Arms (2)

Almonds

EXPERIMENTAL

Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks

Other: Almond

Pretzels

ACTIVE COMPARATOR

Consume 2 oz. serving pretzels (216 calories) daily for 12 weeks

Other: Pretzel

Interventions

Almond OTHER

Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks

Almonds

Pretzel OTHER

Consume 2 oz. serving of pretzels (216 calories) daily for 12 weeks

Pretzels

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Almond Board of California: collaborator

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Zhaoping Li

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: This study will be a randomized, parallel group comparison of almonds vs. isocaloric pretzels.

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 20, 2020
• Study Start: July 25, 2019
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)