Effect of a Low-glycemic-load and Milk-free Diet on Acne Severity
1 other identifier
interventional
60
1 country
1
Brief Summary
The objective of this study is to assess the effect of a low-glycemic-load and milk-free diet on acne severity. IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both groups to explore the mTORC signaling pathway, which is thought to be related to clinical improvement in previous studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedNovember 11, 2013
November 1, 2013
9 months
October 21, 2013
November 8, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
GAGS Acne severity scale
13 weeks
Secondary Outcomes (3)
Serum insulin like growth factor 1 (IGF-1)
13 weeks
Diet acceptability and adherence
13 weeks
p70S6K
13 weeks
Study Arms (2)
Intervention Diet
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Mild, moderate or severe acne (GAGS score 15-44)
- Age: 14-20 years old
- Presence of acne for at least 2 months
You may not qualify if:
- Diabetes
- Polycystic ovary syndrome
- Use of hormonal contraceptives
- Previous use of oral retinoids
- Use of oral antibiotics or topical antibacterial or retinoid agents in the last 2 months
- Use of medications known to cause or exacerbate acne including lithium, oral or injected retinoids, some anticonvulsant drugs, medications containing iodides or bromides
- Drug or alcohol abuse.
- Active smokers
- Anticipated difficulty attending visits or fear of blood draws
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Parc Taulí
Sabadell, Barcelona, 08208, Spain
Related Publications (3)
Kwon HH, Yoon JY, Hong JS, Jung JY, Park MS, Suh DH. Clinical and histological effect of a low glycaemic load diet in treatment of acne vulgaris in Korean patients: a randomized, controlled trial. Acta Derm Venereol. 2012 May;92(3):241-6. doi: 10.2340/00015555-1346.
PMID: 22678562RESULTSmith RN, Mann NJ, Braue A, Makelainen H, Varigos GA. A low-glycemic-load diet improves symptoms in acne vulgaris patients: a randomized controlled trial. Am J Clin Nutr. 2007 Jul;86(1):107-15. doi: 10.1093/ajcn/86.1.107.
PMID: 17616769RESULTReynolds RC, Lee S, Choi JY, Atkinson FS, Stockmann KS, Petocz P, Brand-Miller JC. Effect of the glycemic index of carbohydrates on Acne vulgaris. Nutrients. 2010 Oct;2(10):1060-72. doi: 10.3390/nu2101060. Epub 2010 Oct 18.
PMID: 22253996RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
October 21, 2013
First Posted
October 25, 2013
Study Start
October 1, 2013
Primary Completion
July 1, 2014
Last Updated
November 11, 2013
Record last verified: 2013-11