Low Glycemic Index and Load Diet for the Treatment of Acne

Study Overview
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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.

Official Title
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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

Conditions
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Acne Vulgaris, Diet Modification

Intervention / Treatment
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* Other: Normal diet
* Other: Low glycemic diet
* Drug: Adapalene 0.1% Gel
* Drug: Doxycycline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial, two-arm
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Diet<br>Participants will receive a normal diet according to their metabolic status. | Other: Normal diet<br>* 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.<br>Drug: Adapalene 0.1% Gel<br>* Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.<br>* Other names: Adapalene;Drug: Doxycycline<br>* Doxycycline 100 mg per day orally, before breakfast<br>|
| Experimental: Low glycemic diet<br>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. | Other: Low glycemic diet<br>* 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.<br>Drug: Adapalene 0.1% Gel<br>* Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.<br>* Other names: Adapalene;Drug: Doxycycline<br>* Doxycycline 100 mg per day orally, before breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of inflammatory acne lesions | Number of papules and pustules | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of non-inflammatory acne lesions | Number of comedones | 12 weeks | 
| Changes in quality of life | Score of the Dermatology Life Quality Index | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Vulgaris, Low Glycemic Diet, Doxycycline, Adapalene