The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne

Study Overview
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Brief Summary
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This randomized controlled trial will examine changes in some hormonal markers associated with acne among adults with moderate/severe acne randomized to a low glycemic index and glycemic load diet or usual eating plan for two weeks.

Detailed Description
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The objectives of this randomized controlled trial are to investigate the impact of a low glycemic index/load eating plan on endocrine aspects of acne. Specifically, this study will examine changes in blood biochemical markers of acne among adults with acne following a modified carbohydrate (low glycemic index/load) eating plan or their usual eating plan for two weeks. An external sponsor, Nutrisystem®, will provide some low glycemic index/load foods to the study participants randomized to the intervention group for two weeks. Study outcomes include changes in glucose, insulin, insulin resistance, insulin-like growth factor-1, and insulin-like growth factor binding protein-3 concentrations.

Official Title
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The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: Low Glycemic Load Diet
* Other: Usual Eating Plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) ≥18.5 or <30.0 kg/m2 History of moderate or severe facial acne for at least 6 months Able to read and speak the English language Exclusion Criteria: > 10% weight change within the last 6 months Taking medications known to alter blood glucose or insulin concentrations Medical history of polycystic ovarian syndrome, type 1 diabetes, type 2 diabetes, or pre diabetes Low carbohydrate (<45% of total energy from carbohydrate), glycemic index, or glycemic load diet Female participants that are pregnant or lactating or were pregnant or lactating within the last year Current use of a pacemaker or other battery operated implant Facial hair that would make it difficult for a health care provider to assess facial acne.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Glycemic Load Diet<br>Participants received a diet education to follow a low glycemic load diet and received some low glycemic load staple foods. | Other: Low Glycemic Load Diet<br>* Participants received a diet education on a low glycemic load diet.<br>|
| Active Comparator: Usual Eating Plan<br>Participants received a diet education to continue with their usual diet. | Other: Usual Eating Plan<br>* Participants received a diet education to continue with their usual eating plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose in mg/dL | A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure glucose concentrations | Change from baseline blood glucose concentrations after two weeks. | 
| Insulin in uIL/mL | A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin concentrations | Change from baseline insulin concentrations after two weeks. | 
| Insulin-like growth factor-1 in ng/mL | A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin-like growth factor-1 concentrations | Change from baseline Insulin-like growth factor-1 concentrations after two weeks. | 
| Insulin-like growth factor binding protein-3 in mg/L | A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin-like growth factor binding protein-3 concentrations | Change from baseline insulin-like growth factor binding protein-3 concentrations after two weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Acne specific quality of life among participants following a low glycemic load diet or their usual diet for two weeks. | Acne specific quality of life will be measured using a validated questionnaire. Acne specific quality of life measured the effect of acne on the participants quality of life. | Change in baseline quality of life after two weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, glycemic index, glycemic load, Acne Vulgaris