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Plant-based Dietary Intervention for Treatment of Acne

Primary Purpose

Acne

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-fat, vegan diet
Control
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Washington Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low-fat, vegan diet

Control

Arm Description

Outcomes

Primary Outcome Measures

Number of acne lesions

Secondary Outcome Measures

Diet acceptability and adherence
Acne severity and extent
Quality of life

Full Information

First Posted
May 11, 2009
Last Updated
August 6, 2012
Sponsor
Physicians Committee for Responsible Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00900939
Brief Title
Plant-based Dietary Intervention for Treatment of Acne
Official Title
Plant-based Dietary Intervention for Treatment of Acne
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-fat, vegan diet
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Low-fat, vegan diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study.
Primary Outcome Measure Information:
Title
Number of acne lesions
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Diet acceptability and adherence
Time Frame
16 weeks
Title
Acne severity and extent
Time Frame
16 weeks
Title
Quality of life
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Washington Center for Clinical Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19335417
Citation
Spencer EH, Ferdowsian HR, Barnard ND. Diet and acne: a review of the evidence. Int J Dermatol. 2009 Apr;48(4):339-47. doi: 10.1111/j.1365-4632.2009.04002.x. No abstract available.
Results Reference
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Plant-based Dietary Intervention for Treatment of Acne

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