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

November 8, 2013 updated by: Lorena Leal, MD, Hospital Parc Taulí, Sabadell

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Parc Tauli
        • Principal Investigator:
          • Lorena Leal, Medical Doctor

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

14 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
Placebo Comparator: Control
Experimental: Intervention Diet
Other: Low-glycemic-load and milk-free diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GAGS Acne severity scale
Time Frame: 13 weeks
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum insulin like growth factor 1 (IGF-1)
Time Frame: 13 weeks
13 weeks
Diet acceptability and adherence
Time Frame: 13 weeks
13 weeks
p70S6K
Time Frame: 13 weeks
A phosphorylated product of mTORC signaling pathway
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Parc Taulí, Sabadell

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.

General Publications

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

October 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPT 2013-059

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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