- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00900939
Plant-based Dietary Intervention for Treatment of Acne
August 6, 2012 updated by: Physicians Committee for Responsible Medicine
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20016
- Washington Center for Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of acne lesions
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diet acceptability and adherence
Time Frame: 16 weeks
|
16 weeks
|
Acne severity and extent
Time Frame: 16 weeks
|
16 weeks
|
Quality of life
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
May 11, 2009
First Submitted That Met QC Criteria
May 11, 2009
First Posted (Estimate)
May 13, 2009
Study Record Updates
Last Update Posted (Estimate)
August 7, 2012
Last Update Submitted That Met QC Criteria
August 6, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acne001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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