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Almond Supplementation on Mild to Moderate Acne

Primary Purpose

Acne Vulgaris

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food: whole almonds
Food: non-nut snack
Sponsored by
Integrative Skin Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring microbiome, nutrition

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Integrative Skin Science and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Almonds

Control Snack

Arm Description

Daily consumption of almonds.

Daily non-nut snack will be consumed.

Outcomes

Primary Outcome Measures

Total lesion count
Number of of inflammatory lesions, and open and closed comedones

Secondary Outcome Measures

Inflammatory lesion count
Number of inflammatory lesions
Inflammatory lesion count
Number of inflammatory lesions
Non-inflammatory lesion count
Number of open and closed comedones
Non-inflammatory lesion count
Number of open and closed comedones
Investigator global assessment (IGA) of acne
Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.
Investigator global assessment (IGA) of acne
Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.
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.
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.
Sebum excretion
Measure of skin sebum via sebumeter.
Sebum excretion
Measure of skin sebum via sebumeter
Gut microbiome assessment
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Gut microbiome assessment
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Skin microbiome diversity
Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.
Skin microbiome diversity
Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.

Full Information

First Posted
February 12, 2022
Last Updated
February 25, 2022
Sponsor
Integrative Skin Science and Research
Collaborators
Almond Board of California
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1. Study Identification

Unique Protocol Identification Number
NCT05269641
Brief Title
Almond Supplementation on Mild to Moderate Acne
Official Title
The Effect of Almond Supplementation on Mild to Moderate Acne
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
Almond Board of California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
microbiome, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Almonds
Arm Type
Experimental
Arm Description
Daily consumption of almonds.
Arm Title
Control Snack
Arm Type
Placebo Comparator
Arm Description
Daily non-nut snack will be consumed.
Intervention Type
Other
Intervention Name(s)
Food: whole almonds
Intervention Description
60g of whole almonds will be consumed daily.
Intervention Type
Other
Intervention Name(s)
Food: non-nut snack
Intervention Description
A non-nut snack will be consumed daily.
Primary Outcome Measure Information:
Title
Total lesion count
Description
Number of of inflammatory lesions, and open and closed comedones
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Inflammatory lesion count
Description
Number of inflammatory lesions
Time Frame
12 weeks
Title
Inflammatory lesion count
Description
Number of inflammatory lesions
Time Frame
20 weeks
Title
Non-inflammatory lesion count
Description
Number of open and closed comedones
Time Frame
12 weeks
Title
Non-inflammatory lesion count
Description
Number of open and closed comedones
Time Frame
20 weeks
Title
Investigator global assessment (IGA) of acne
Description
Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.
Time Frame
12 weeks
Title
Investigator global assessment (IGA) of acne
Description
Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.
Time Frame
20 weeks
Title
Quality of Life Survey
Description
Dermatology quality of life index survey assessment (DQLI). Scale is 0 to 30, the higher the score the greater impairments to quality of life.
Time Frame
12 weeks
Title
Quality of Life Survey
Description
Dermatology quality of life index survey assessment (DQLI). Scale is 0 to 30, the higher the score the greater impairments to quality of life.
Time Frame
20 weeks
Title
Sebum excretion
Description
Measure of skin sebum via sebumeter.
Time Frame
12 weeks
Title
Sebum excretion
Description
Measure of skin sebum via sebumeter
Time Frame
20 weeks
Title
Gut microbiome assessment
Description
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Time Frame
12 weeks
Title
Gut microbiome assessment
Description
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Time Frame
20 weeks
Title
Skin microbiome diversity
Description
Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.
Time Frame
12 weeks
Title
Skin microbiome diversity
Description
Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Maloh
Phone
9167502463
Email
jessica@integrativeskinresearch.com
Facility Information:
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Maloh
Phone
916-750-2463
Email
raja.sivamani@integrativeskinresearch.com
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD MS AP

12. IPD Sharing Statement

Plan to Share IPD
No

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Almond Supplementation on Mild to Moderate Acne

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