Almond Supplementation on Mild to Moderate Acne

Acne Vulgaris Clinical Trial

Official title:

The Effect of Almond Supplementation on Mild to Moderate Acne

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269641
• Other study ID #: AlmondAcne_01
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2022
• Source: Integrative Skin Science and Research
• Contact: Jessica Maloh
• Phone: 9167502463
• Email: jessica[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• Food: whole almonds
60g of whole almonds will be consumed daily.
• Food: non-nut snack
A non-nut snack will be consumed daily.

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total lesion count	Number of of inflammatory lesions, and open and closed comedones	20 weeks
Secondary	Inflammatory lesion count	Number of inflammatory lesions	12 weeks
Secondary	Inflammatory lesion count	Number of inflammatory lesions	20 weeks
Secondary	Non-inflammatory lesion count	Number of open and closed comedones	12 weeks
Secondary	Non-inflammatory lesion count	Number of open and closed comedones	20 weeks
Secondary	Investigator global assessment (IGA) of acne	Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.	12 weeks
Secondary	Investigator global assessment (IGA) of acne	Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.	20 weeks
Secondary	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
Secondary	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
Secondary	Sebum excretion	Measure of skin sebum via sebumeter.	12 weeks
Secondary	Sebum excretion	Measure of skin sebum via sebumeter	20 weeks
Secondary	Gut microbiome assessment	Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample	12 weeks
Secondary	Gut microbiome assessment	Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample	20 weeks
Secondary	Skin microbiome diversity	Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.	12 weeks
Secondary	Skin microbiome diversity	Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.	20 weeks