Plant-based Dietary Intervention for Treatment of Acne
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Plant-based Dietary Intervention for Treatment of Acne|
- Number of acne lesions [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Diet acceptability and adherence [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Acne severity and extent [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|Experimental: Low-fat, vegan diet||
Behavioral: Low-fat, vegan diet
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.
|Placebo Comparator: Control||
Participants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900939
|United States, District of Columbia|
|Washington Center for Clinical Research|
|Washington, District of Columbia, United States, 20016|