Effect of a Low-glycemic-load and Milk-free Diet on Acne Severity

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01969175
• Other study ID #: HPT 2013-059
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2013
• Last updated: November 8, 2013
• Start date: October 2013

Study information

• Verified date: November 2013
• Source: Hospital Parc Taulí, Sabadell
• Contact: Lorena Leal, Medical Doctor
• Phone: +34653358555
• Email: lorenalealcanosa[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 20 Years

Eligibility

Inclusion Criteria:

• Mild, moderate or severe acne (GAGS score 15-44)

• Age: 14-20 years old

• Presence of acne for at least 2 months

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• Low-glycemic-load and milk-free diet

Locations

Country	Name	City	State
Spain	Hospital Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Parc Taulí, Sabadell

Country where clinical trial is conducted

Spain, 

References & 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: 10.2340/000 — View Citation

Reynolds 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. — View Citation

Smith RN, Mann NJ, Braue A, Mäkeläinen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GAGS Acne severity scale		13 weeks	No
Secondary	Serum insulin like growth factor 1 (IGF-1)		13 weeks	No
Secondary	Diet acceptability and adherence		13 weeks	No
Secondary	p70S6K	A phosphorylated product of mTORC signaling pathway	13 weeks	No