Acne Vulgaris
Conditions
Keywords
microbiome, nutrition
Brief summary
This study will assess the effect of almond supplementation on acne and on gut health.
Interventions
OTHERFood: whole almonds
60g of whole almonds will be consumed daily.
OTHERFood: non-nut snack
A non-nut snack will be consumed daily.
Sponsors
Almond Board of California
Integrative Skin Science and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total lesion count | 20 weeks | Number of of inflammatory lesions, and open and closed comedones |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-inflammatory lesion count | 12 weeks | Number of open and closed comedones |
| Investigator global assessment (IGA) of acne | 12 weeks | Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity. |
| Quality of Life Survey | 12 weeks | Dermatology quality of life index survey assessment (DQLI). Scale is 0 to 30, the higher the score the greater impairments to quality of life. |
| Inflammatory lesion count | 12 weeks | Number of inflammatory lesions |
| Gut microbiome assessment | 12 weeks | Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample |
| Skin microbiome diversity | 12 weeks | Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection. |
| Sebum excretion | 12 weeks | Measure of skin sebum via sebumeter. |
Countries
United States
Contacts
Primary ContactJessica Maloh
Outcome results
None listed