Low Glycemic Index and Load Diet for the Treatment of Acne

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

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.

Study Overview

• Status: Completed
• Conditions: Diet Modification; Acne Vulgaris
• Intervention / Treatment: Other: Normal diet; Drug: Adapalene 0.1% Gel; Drug: Doxycycline; Other: Low glycemic diet

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
• Investigators: Principal Investigator: Martha A Morales-Sánchez, MD, Centro Dermatológico Dr. Ladislao de la Pascua

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Doxycycline; Acne Vulgaris; Adapalene; Low Glycemic Diet
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline; Adapalene
• Other Study ID Numbers: 106/2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No