Almond Supplementation on Mild to Moderate Acne

Study Overview
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Brief Summary
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This study will assess the effect of almond supplementation on acne and on gut health.

Official Title
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The Effect of Almond Supplementation on Mild to Moderate Acne

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: Food: whole almonds
* Other: Food: non-nut snack


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almonds<br>Daily consumption of almonds. | Other: Food: whole almonds<br>* 60g of whole almonds will be consumed daily.<br>|
| Placebo Comparator: Control Snack<br>Daily non-nut snack will be consumed. | Other: Food: non-nut snack<br>* A non-nut snack will be consumed daily.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, nutrition