Plant-based Dietary Intervention for Treatment of Acne

Study Overview
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Brief Summary
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The purpose of this study is to determine if a low-fat, vegan diet affects the number of acne lesions, acne severity, and acne extent.

Detailed Description
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Acne is the most common skin disorder in the United States. Although many cases are transient, the condition is often chronic, causing self-consciousness and social stigmatization over the short term and physical scars and damaged self-esteem over the long term. Patients and clinicians have frequently attributed acnegenesis to diet; studies of varying quality have been published on the topic since the 1830s. Recently, well-designed, controlled, prospective studies suggest an acnegenic effect of specific dietary factors, including high-glycemic-index foods and dairy products. Limited evidence also suggests an acnegenic effect of foods containing saturated fats. More well-designed, randomized, controlled trials are needed to further establish dietary effects on acne. Based on epidemiologic observations and results of prior clinical trials, we are conducting a pilot study to determine if a low-fat, low-glycemic-index vegan diet affects the number of acne lesions and acne severity.

Official Title
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Plant-based Dietary Intervention for Treatment of Acne

Conditions
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Acne

Intervention / Treatment
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* Behavioral: Low-fat, vegan diet
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female gender Mild, moderate, or severe acne, as indicated by an Evaluator Global Severity Score (EGSS) score of 2, 3, or 4 Presence of at least 10 inflammatory or 20 non-inflammatory lesions on the face Presence of acne for at least 3 months (by volunteer's history) Age at least 18 years Ability and willingness to participate in all components of the study Willingness to be assigned randomly to a low-fat, vegan diet or a control group Intention to remain in the Washington DC area for the 16-week study period. Exclusion Criteria: Change in use or dosage of hormone-based contraceptives in the last 3 months or anticipated change during the study period. Use of depot medoxyprogesterone contraception Use of oral retinoids in the last 6 months Use of high doses of vitamin A in the last 3 weeks (≥ 10,000 IU) Use of oral antibiotics or topical antibacterial or retinoid agents in the last 1 month Presence of more than two nodules or cysts on the face or more than two nodules or cysts on the back and chest. Use of medications known to cause or exacerbate acne including lithium, oral or injected steroids, or medications containing iodides or bromides History of alcohol abuse or dependency followed by any current use Current or unresolved past drug or alcohol abuse Facial hair that would interfere with making acne assessments Pregnancy or breastfeeding (currently or in the past 3 months), or intent to become pregnant in the next 4 months History of severe mental illness within the past 3 years Unstable medical status Current dietary pattern that is low-fat and vegan Anticipated difficulty attending or participating in group sessions Inordinate fear of blood draws Diabetes treated with insulin or any other medications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-fat, vegan diet<br> | Behavioral: Low-fat, vegan diet<br>* Participants in the intervention group will be asked to follow a low-fat, vegan diet for the full 16 weeks of the study. They will also be guided to favor foods with a low glycemic index. The diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products, added oils, and added sugars will be excluded.<br>|
| Placebo Comparator: Control<br> | Behavioral: Control<br>* Participants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of acne lesions |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet acceptability and adherence |  | 16 weeks | 
| Acne severity and extent |  | 16 weeks | 
| Quality of life |  | 16 weeks |