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

NCT ID: NCT04352504

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-25
• Study Completion Date: 2020-01-23

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.

Conditions

Skin Laxity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Almonds

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

Group Type: EXPERIMENTAL

Almond

Intervention Type: OTHER

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

Pretzels

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

Group Type: ACTIVE_COMPARATOR

Pretzel

Intervention Type: OTHER

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

Interventions

Almond

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

Intervention Type: OTHER

Pretzel

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Almond Board of California

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Zhaoping Li

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhaoping Li

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Center for Human Nutrition

Los Angeles, California, United States

Countries

United States

Other Identifiers

18-002001

Identifier Type: -

Identifier Source: org_study_id