Plant-based Dietary Intervention for Treatment of Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT00900939
First received: May 11, 2009
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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 Intervention
Acne
Behavioral: Low-fat, vegan diet
Behavioral: Control

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Physicians Committee for Responsible Medicine:

Primary Outcome Measures:
  • Number of acne lesions [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900939

Locations
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
  More Information

Publications:
Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT00900939     History of Changes
Other Study ID Numbers: Acne001
Study First Received: May 11, 2009
Last Updated: August 6, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on August 28, 2014