Plant-based Dietary Intervention for Treatment of Acne
- Conditions
- Acne
- Interventions
- Behavioral: Low-fat, vegan dietBehavioral: Control
- Registration Number
- NCT00900939
- Lead Sponsor
- Physicians Committee for Responsible Medicine
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-fat, vegan diet Low-fat, vegan diet - Control Control -
- Primary Outcome Measures
Name Time Method Number of acne lesions 16 weeks
- Secondary Outcome Measures
Name Time Method Quality of life 16 weeks Diet acceptability and adherence 16 weeks Acne severity and extent 16 weeks
Trial Locations
- Locations (1)
Washington Center for Clinical Research
🇺🇸Washington, District of Columbia, United States