Almond Supplementation on Mild to Moderate Acne

The Effect of Almond Supplementation on Mild to Moderate Acne

This study will assess the effect of almond supplementation on acne and on gut health.

Study Overview

• Status: Recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: Food: whole almonds; Other: Food: non-nut snack

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Maloh; Phone Number: 9167502463; Email: jessica@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95819
      • Recruiting
      • Integrative Skin Science and Research
      • Principal Investigator: Raja Sivamani, MD MS AP
      • Contact: Jessica Maloh; Phone Number: 916-750-2463; Email: raja.sivamani@integrativeskinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects 15 years of age until 45 years of age.
• The presence of mild to moderate acne based on investigator global assessment.
• Individuals who have remained stable on their topical or oral acne regimen for at least 4 weeks, except if the medication is a noted exclusion.

Exclusion Criteria:

• The presence of severe acne as noted by the investigator global assessment.
• Those with a nut allergy.
• Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.
• Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.
• Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.
• Individuals who have been on an oral antibiotic for acne within the previous 1 month.
• Individuals who are pregnant or breastfeeding.
• Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
• Oral supplementation that has nuts in it.
• Use of isotretinoin within the three months prior to joining the study.
• Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Almonds; Daily consumption of almonds.	Other: Food: whole almonds; 60g of whole almonds will be consumed daily.
PLACEBO_COMPARATOR: Control Snack; Daily non-nut snack will be consumed.	Other: Food: non-nut snack; A non-nut snack will be consumed daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total lesion count	Number of of inflammatory lesions, and open and closed comedones	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory lesion count	Number of inflammatory lesions	12 weeks
Inflammatory lesion count	Number of inflammatory lesions	20 weeks
Non-inflammatory lesion count	Number of open and closed comedones	12 weeks
Non-inflammatory lesion count	Number of open and closed comedones	20 weeks
Investigator global assessment (IGA) of acne	Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.	12 weeks
Investigator global assessment (IGA) of acne	Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.	20 weeks
Quality of Life Survey	Dermatology quality of life index survey assessment (DQLI). Scale is 0 to 30, the higher the score the greater impairments to quality of life.	12 weeks
Quality of Life Survey	Dermatology quality of life index survey assessment (DQLI). Scale is 0 to 30, the higher the score the greater impairments to quality of life.	20 weeks
Sebum excretion	Measure of skin sebum via sebumeter.	12 weeks
Sebum excretion	Measure of skin sebum via sebumeter	20 weeks
Gut microbiome assessment	Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample	12 weeks
Gut microbiome assessment	Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample	20 weeks
Skin microbiome diversity	Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.	12 weeks
Skin microbiome diversity	Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.	20 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Almond Board of California

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 28, 2022
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: February 12, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (ACTUAL): March 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: nutrition; microbiome
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: AlmondAcne_01

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