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Completed

NCT Number: NCT00900939

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington Center for Clinical Research

Washington D.C., District of Columbia, 20016, United States

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

low-fat, vegan diet

Behavioral

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.

Control

Behavioral

Participants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study.

Primary outcomes

  1. Number of acne lesions

    Time frame: 16 weeks

Secondary outcomes

  1. Diet acceptability and adherence

    Time frame: 16 weeks

  2. Acne severity and extent

    Time frame: 16 weeks

  3. Quality of life

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
May 13, 2009
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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