Almond Supplementation on Mild to Moderate Acne
The Effect of Almond Supplementation on Mild to Moderate Acne
1 other identifier
interventional
60
1 country
1
Brief Summary
This study will assess the effect of almond supplementation on acne and on gut health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2022
CompletedStudy Start
First participant enrolled
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 8, 2022
February 1, 2022
2.3 years
February 12, 2022
February 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total lesion count
Number of of inflammatory lesions, and open and closed comedones
20 weeks
Secondary Outcomes (14)
Inflammatory lesion count
12 weeks
Inflammatory lesion count
20 weeks
Non-inflammatory lesion count
12 weeks
Non-inflammatory lesion count
20 weeks
Investigator global assessment (IGA) of acne
12 weeks
- +9 more secondary outcomes
Study Arms (2)
Almonds
EXPERIMENTALDaily consumption of almonds.
Control Snack
PLACEBO COMPARATORDaily non-nut snack will be consumed.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects 15 years of age until 45 years of age.
- The presence of mild to moderate acne based on investigator global assessment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integrative Skin Science and Researchlead
- Almond Board of Californiacollaborator
Study Sites (1)
Integrative Skin Science and Research
Sacramento, California, 95819, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 12, 2022
First Posted
March 8, 2022
Study Start
February 28, 2022
Primary Completion
June 1, 2024
Study Completion
December 1, 2024
Last Updated
March 8, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share