Low Glycemic Index and Load Diet for the Treatment of Acne

NCT ID: NCT03585140

Last Updated: 2018-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris Diet Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial, two-arm
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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Normal Diet

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

Group Type ACTIVE_COMPARATOR

Normal diet

Intervention Type OTHER

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.

Adapalene 0.1% Gel

Intervention Type DRUG

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

Doxycycline

Intervention Type DRUG

Doxycycline 100 mg per day orally, before breakfast

Low glycemic diet

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.

Group Type EXPERIMENTAL

Low glycemic diet

Intervention Type OTHER

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.

Adapalene 0.1% Gel

Intervention Type DRUG

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

Doxycycline

Intervention Type DRUG

Doxycycline 100 mg per day orally, before breakfast

Interventions

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Normal diet

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

Low glycemic diet

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 OTHER

Adapalene 0.1% Gel

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

Intervention Type DRUG

Doxycycline

Doxycycline 100 mg per day orally, before breakfast

Intervention Type DRUG

Other Intervention Names

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Adapalene

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centro Dermatológico Dr. Ladislao de la Pascua

OTHER

Sponsor Role lead

Responsible Party

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Dra. Martha Alejandra Morales Sánchez

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martha A Morales-Sánchez, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Dermatológico Dr. Ladislao de la Pascua

Other Identifiers

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106/2016

Identifier Type: -

Identifier Source: org_study_id

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