Almond Supplementation on Mild to Moderate Acne

NCT ID: NCT05269641

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2024-12-01

Brief Summary

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

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Almonds

Daily consumption of almonds.

Group Type EXPERIMENTAL

Food: whole almonds

Intervention Type OTHER

60g of whole almonds will be consumed daily.

Control Snack

Daily non-nut snack will be consumed.

Group Type PLACEBO_COMPARATOR

Food: non-nut snack

Intervention Type OTHER

A non-nut snack will be consumed daily.

Interventions

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Food: whole almonds

60g of whole almonds will be consumed daily.

Intervention Type OTHER

Food: non-nut snack

A non-nut snack will be consumed daily.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Almond Board of California

OTHER

Sponsor Role collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Raja Sivamani, MD MS AP

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Integrative Skin Science and Research

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Maloh

Role: CONTACT

9167502463

Facility Contacts

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Jessica Maloh

Role: primary

916-750-2463

Other Identifiers

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AlmondAcne_01

Identifier Type: -

Identifier Source: org_study_id

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