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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Primary Endpoint
- Count of inflammatory acne lesions
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Diet intervention was made by the nutrition specialist. Neither the principal investigator nor the outcome assessor were aware about the group of diet intervention.
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Having moderate inflammatory acne
- •18 to 25 years old
- •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
Arms & Interventions
Normal Diet
Participants will receive a normal diet according to their metabolic status.
Intervention: Normal diet (Other)
Normal Diet
Participants will receive a normal diet according to their metabolic status.
Intervention: Adapalene 0.1% Gel (Drug)
Normal Diet
Participants will receive a normal diet according to their metabolic status.
Intervention: Doxycycline (Drug)
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.
Intervention: Low glycemic diet (Other)
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.
Intervention: Adapalene 0.1% Gel (Drug)
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.
Intervention: Doxycycline (Drug)
Outcomes
Primary Outcomes
Count of inflammatory acne lesions
Time Frame: 12 weeks
Number of papules and pustules
Secondary Outcomes
- Count of non-inflammatory acne lesions(12 weeks)
- Changes in quality of life(12 weeks)
Investigators
Dra. Martha Alejandra Morales Sánchez
MD
Centro Dermatológico Dr. Ladislao de la Pascua