Low Glycemic Index and Load Diet for the Treatment of Acne

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585140
• Other study ID #: 106/2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: July 2018
• Source: Centro Dermatológico Dr. Ladislao de la Pascua
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 30, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Diet Modification

Intervention

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.
• 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.

Drug:
• Adapalene 0.1% Gel
Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.
• Doxycycline
Doxycycline 100 mg per day orally, before breakfast

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Dermatológico Dr. Ladislao de la Pascua

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of inflammatory acne lesions	Number of papules and pustules	12 weeks
Secondary	Count of non-inflammatory acne lesions	Number of comedones	12 weeks
Secondary	Changes in quality of life	Score of the Dermatology Life Quality Index	12 weeks