Plant-based Dietary Intervention for Treatment of Acne
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Number of acne lesions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
干预措施: Control (Behavioral)
Low-fat, vegan diet
干预措施: Low-fat, vegan diet (Behavioral)
结局指标
主要结局
Number of acne lesions
时间窗: 16 weeks
次要结局
- Quality of life(16 weeks)
- Diet acceptability and adherence(16 weeks)
- Acne severity and extent(16 weeks)