Back to results

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

Primary Purpose

Acne Vulgaris

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Low-glycemic-load and milk-free diet

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Parc TaulíRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Diet

Control

Arm Description

Outcomes

Primary Outcome Measures

GAGS Acne severity scale

Secondary Outcome Measures

Serum insulin like growth factor 1 (IGF-1)

Diet acceptability and adherence

p70S6K

A phosphorylated product of mTORC signaling pathway

Full Information

NCT ID

NCT01969175

First Posted

October 21, 2013

Last Updated

November 8, 2013

Sponsor

Parc Taulí Hospital Universitari

1. Study Identification

Unique Protocol Identification Number

NCT01969175

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Parc Taulí Hospital Universitari

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Diet

Arm Type

Experimental

Arm Title

Control

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Low-glycemic-load and milk-free diet

Primary Outcome Measure Information:

Title

GAGS Acne severity scale

Time Frame

13 weeks

Secondary Outcome Measure Information:

Title

Serum insulin like growth factor 1 (IGF-1)

Time Frame

13 weeks

Title

Diet acceptability and adherence

Time Frame

13 weeks

Title

p70S6K

Description

A phosphorylated product of mTORC signaling pathway

Time Frame

13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lorena Leal, Medical Doctor

Phone

+34653358555

lorenalealcanosa@hotmail.com

Facility Information:

Facility Name

Hospital Parc Taulí

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lorena Leal, Medical Doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

22678562

Citation

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.

Results Reference

result

PubMed Identifier

17616769

Citation

Smith 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.

Results Reference

result

PubMed Identifier

22253996

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs