Almond Supplementation on Mild to Moderate Acne

Sponsor
Integrative Skin Science and Research (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05269641
Collaborator
Almond Board of California (Other)
60
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2
33.1
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Food: whole almonds
  • Other: Food: non-nut snack
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Almond Supplementation on Mild to Moderate Acne
Anticipated Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Total lesion count [20 weeks]

    Number of of inflammatory lesions, and open and closed comedones

Secondary Outcome Measures

  1. Inflammatory lesion count [12 weeks]

    Number of inflammatory lesions

  2. Inflammatory lesion count [20 weeks]

    Number of inflammatory lesions

  3. Non-inflammatory lesion count [12 weeks]

    Number of open and closed comedones

  4. Non-inflammatory lesion count [20 weeks]

    Number of open and closed comedones

  5. Investigator global assessment (IGA) of acne [12 weeks]

    Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.

  6. Investigator global assessment (IGA) of acne [20 weeks]

    Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.

  7. 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.

  8. Quality of Life Survey [20 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.

  9. Sebum excretion [12 weeks]

    Measure of skin sebum via sebumeter.

  10. Sebum excretion [20 weeks]

    Measure of skin sebum via sebumeter

  11. Gut microbiome assessment [12 weeks]

    Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample

  12. Gut microbiome assessment [20 weeks]

    Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample

  13. Skin microbiome diversity [12 weeks]

    Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.

  14. Skin microbiome diversity [20 weeks]

    Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Integrative Skin Science and Research Sacramento California United States 95819

Sponsors and Collaborators

  • Integrative Skin Science and Research
  • Almond Board of California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Raja Sivamani, MD MS AP, Principal Investigator, Integrative Skin Science and Research
ClinicalTrials.gov Identifier:
NCT05269641
Other Study ID Numbers:
  • AlmondAcne_01
First Posted:
Mar 8, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Raja Sivamani, MD MS AP, Principal Investigator, Integrative Skin Science and Research
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022