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Plant-based Dietary Intervention for Treatment of Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00900939
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acne Behavioral: Low-fat, vegan diet Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Plant-based Dietary Intervention for Treatment of Acne
Study Start Date : July 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
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 Behavioral: Control
Participants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study.

Primary Outcome Measures :
  1. Number of acne lesions [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male or female gender
  2. Mild, moderate, or severe acne, as indicated by an Evaluator Global Severity Score (EGSS) score of 2, 3, or 4
  3. Presence of at least 10 inflammatory or 20 non-inflammatory lesions on the face
  4. Presence of acne for at least 3 months (by volunteer's history)
  5. Age at least 18 years
  6. Ability and willingness to participate in all components of the study
  7. Willingness to be assigned randomly to a low-fat, vegan diet or a control group
  8. Intention to remain in the Washington DC area for the 16-week study period.

Exclusion Criteria:

  1. Change in use or dosage of hormone-based contraceptives in the last 3 months or anticipated change during the study period.
  2. Use of depot medoxyprogesterone contraception
  3. Use of oral retinoids in the last 6 months
  4. Use of high doses of vitamin A in the last 3 weeks (≥ 10,000 IU)
  5. Use of oral antibiotics or topical antibacterial or retinoid agents in the last 1 month
  6. Presence of more than two nodules or cysts on the face or more than two nodules or cysts on the back and chest.
  7. Use of medications known to cause or exacerbate acne including lithium, oral or injected steroids, or medications containing iodides or bromides
  8. History of alcohol abuse or dependency followed by any current use
  9. Current or unresolved past drug or alcohol abuse
  10. Facial hair that would interfere with making acne assessments
  11. Pregnancy or breastfeeding (currently or in the past 3 months), or intent to become pregnant in the next 4 months
  12. History of severe mental illness within the past 3 years
  13. Unstable medical status
  14. Current dietary pattern that is low-fat and vegan
  15. Anticipated difficulty attending or participating in group sessions
  16. Inordinate fear of blood draws
  17. Diabetes treated with insulin or any other medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00900939

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United States, District of Columbia
Washington Center for Clinical Research
Washington, District of Columbia, United States, 20016
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
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Responsible Party: Physicians Committee for Responsible Medicine Identifier: NCT00900939    
Other Study ID Numbers: Acne001
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases