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Almond Supplementation on Mild to Moderate Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05269641
Recruitment Status : Recruiting
First Posted : March 8, 2022
Last Update Posted : March 8, 2022
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Raja Sivamani, MD MS AP, Integrative Skin Science and Research

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Other: Food: whole almonds Other: Food: non-nut snack Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : February 28, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Total lesion count [ Time Frame: 20 weeks ]
    Number of of inflammatory lesions, and open and closed comedones


Secondary Outcome Measures :
  1. Inflammatory lesion count [ Time Frame: 12 weeks ]
    Number of inflammatory lesions

  2. Inflammatory lesion count [ Time Frame: 20 weeks ]
    Number of inflammatory lesions

  3. Non-inflammatory lesion count [ Time Frame: 12 weeks ]
    Number of open and closed comedones

  4. Non-inflammatory lesion count [ Time Frame: 20 weeks ]
    Number of open and closed comedones

  5. Investigator global assessment (IGA) of acne [ Time Frame: 12 weeks ]
    Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.

  6. Investigator global assessment (IGA) of acne [ Time Frame: 20 weeks ]
    Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.

  7. Quality of Life Survey [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Measure of skin sebum via sebumeter.

  10. Sebum excretion [ Time Frame: 20 weeks ]
    Measure of skin sebum via sebumeter

  11. Gut microbiome assessment [ Time Frame: 12 weeks ]
    Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample

  12. Gut microbiome assessment [ Time Frame: 20 weeks ]
    Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample

  13. Skin microbiome diversity [ Time Frame: 12 weeks ]
    Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.

  14. Skin microbiome diversity [ Time Frame: 20 weeks ]
    Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05269641


Contacts
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Contact: Jessica Maloh 9167502463 jessica@integrativeskinresearch.com

Locations
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United States, California
Integrative Skin Science and Research Recruiting
Sacramento, California, United States, 95819
Contact: Jessica Maloh    916-750-2463    raja.sivamani@integrativeskinresearch.com   
Principal Investigator: Raja Sivamani, MD MS AP         
Sponsors and Collaborators
Integrative Skin Science and Research
Almond Board of California
More Information
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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: March 8, 2022    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Integrative Skin Science and Research:
microbiome
nutrition
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases