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Completed

NCT Number: NCT03585140

Low Glycemic Index and Load Diet for the Treatment of Acne

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Diet Modification Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Diet

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.

Low glycemic diet

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

Drug

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

Other names: Adapalene

Doxycycline

Drug

Doxycycline 100 mg per day orally, before breakfast

Primary outcomes

  1. Count of inflammatory acne lesions

    Time frame: 12 weeks

    Number of papules and pustules

Secondary outcomes

  1. Count of non-inflammatory acne lesions

    Time frame: 12 weeks

    Number of comedones

  2. Changes in quality of life

    Time frame: 12 weeks

    Score of the Dermatology Life Quality Index

Sponsors and collaborators

Lead sponsor

Centro Dermatológico Dr. Ladislao de la Pascua

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 12, 2018
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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