Recruiting

Almond Supplementation

Sponsor:

Integrative Skin Science and Research

Code:

NCT05269641

Conditions

Acne Vulgaris

Eligibility Criteria

Sex: All

Age: 15 - 45

Healthy Volunteers: Accepted

Interventions

Food: whole almonds

Food: non-nut snack

Study Details

Brief summary:

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

Conditions

Acne Vulgaris

Study ID

NCT05269641

Start date

Feb 28, 2022

Status verified date

Feb, 2022

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Jun 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Almonds

Daily consumption of almonds.

placebo comparator: Control Snack

Daily non-nut snack will be consumed.

Interventions

Food: whole almonds

60g of whole almonds will be consumed daily.

Food: non-nut snack

A non-nut snack will be consumed daily.

Primary outcome measure

  • Total lesion count [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

Jessica Maloh

9167502463jessica@integrativeskinresearch.com

Locations

Integrative Skin Science and Research

Recruiting

Sacramento, California, United States, 95819

Contacts

Jessica Maloh

916-750-2463raja.sivamani@integrativeskinresearch.com

Principal Investigator:

Raja Sivamani, MD MS AP

More Information

Sponsor

Integrative Skin Science and Research

Last update posted

Mar 8, 2022

Last verified

Feb, 2022

Keywords

  • microbiome
  • nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Integrative Skin Science and Research on 2022-03-08.