Back to results

Low Glycemic Index and Load Diet for the Treatment of Acne

Primary Purpose

Acne Vulgaris, Diet Modification

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Normal diet

Low glycemic diet

Adapalene 0.1% Gel

Doxycycline

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Low Glycemic Diet, Doxycycline, Adapalene

Eligibility Criteria

18 Years - 25 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Having moderate inflammatory acne
18 to 25 years old
Male
Stable weight during the last 3 months

Exclusion Criteria:

Previous or actual isotretinoin therapy
Antibiotic therapy or during the last 3 months
Therapy based on peelings, dermabrasion, laser or intense pulsed light during the last 6 months
Endocrine disorders
Drug and alcohol consumption during the last 6 months
Tabacco use during the last 6 months
Lactose intolerance
Have eating disorders or gastrointestinal disorders
Actual nutrition therapy
Have chronic diseases that requires pharmacologic therapy
Severe acne that requires isotretinoin therapy

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal Diet

Low glycemic diet

Arm Description

Participants will receive a normal diet according to their metabolic status.

Participants will receive a low-glycemic index and load diet according to their metabolic status. Milk and vitamin supplements will be eliminated from the diet.

Outcomes

Primary Outcome Measures

Count of inflammatory acne lesions

Number of papules and pustules

Secondary Outcome Measures

Count of non-inflammatory acne lesions

Number of comedones

Changes in quality of life

Score of the Dermatology Life Quality Index

Full Information

NCT ID

NCT03585140

First Posted

June 29, 2018

Last Updated

July 12, 2018

Sponsor

Centro Dermatológico Dr. Ladislao de la Pascua

1. Study Identification

Unique Protocol Identification Number

NCT03585140

Brief Title

Low Glycemic Index and Load Diet for the Treatment of Acne

Official Title

Effect of Adding a Diet With Low Glycemic Index and Load During 12 Weeks for the Treatment of Moderate Acne in Adults: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

May 1, 2016 (Actual)

Study Completion Date

November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centro Dermatológico Dr. Ladislao de la Pascua

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. Outcomes were measured at week 12.

Detailed Description

Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Both groups of treatment were treated with doxycycline 100 mg per day plus adapalene 0.1% gel daily for 12 weeks. During pharmacologic treatment, all patients had nutrition counseling monthly. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. At the end of the trial, the change in acne lesions count was analyzed and also their metabolic status. Quality of life was also measured.

6. Conditions and Keywords

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

Acne Vulgaris, Diet Modification

Keywords

Acne Vulgaris, Low Glycemic Diet, Doxycycline, Adapalene

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized clinical trial, two-arm

Masking

InvestigatorOutcomes Assessor

Masking Description

Diet intervention was made by the nutrition specialist. Neither the principal investigator nor the outcome assessor were aware about the group of diet intervention.

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal Diet

Arm Type

Active Comparator

Arm Description

Participants will receive a normal diet according to their metabolic status.

Arm Title

Low glycemic diet

Arm Type

Experimental

Arm Description

Participants will receive a low-glycemic index and load diet according to their metabolic status. Milk and vitamin supplements will be eliminated from the diet.

Intervention Type

Other

Intervention Name(s)

Normal diet

Intervention Description

The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins.

Intervention Type

Other

Intervention Name(s)

Low glycemic diet

Intervention Description

The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. A list of foods classified as having low index and glycemic load was used according to the mexican equivalent food system. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins. Milk and vitamin supplements will be eliminated from the diet.

Intervention Type

Drug

Intervention Name(s)

Adapalene 0.1% Gel

Other Intervention Name(s)

Adapalene

Intervention Description

Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.

Intervention Type

Drug

Intervention Name(s)

Doxycycline

Intervention Description

Doxycycline 100 mg per day orally, before breakfast

Primary Outcome Measure Information:

Title

Count of inflammatory acne lesions

Description

Number of papules and pustules

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Count of non-inflammatory acne lesions

Description

Number of comedones

Time Frame

12 weeks

Title

Changes in quality of life

Description

Score of the Dermatology Life Quality Index

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Having moderate inflammatory acne 18 to 25 years old Male Stable weight during the last 3 months Exclusion Criteria: Previous or actual isotretinoin therapy Antibiotic therapy or during the last 3 months Therapy based on peelings, dermabrasion, laser or intense pulsed light during the last 6 months Endocrine disorders Drug and alcohol consumption during the last 6 months Tabacco use during the last 6 months Lactose intolerance Have eating disorders or gastrointestinal disorders Actual nutrition therapy Have chronic diseases that requires pharmacologic therapy Severe acne that requires isotretinoin therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martha A Morales-Sánchez, MD

Organizational Affiliation

Centro Dermatológico Dr. Ladislao de la Pascua

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Low Glycemic Index and Load Diet for the Treatment of Acne

We'll reach out to this number within 24 hrs