Acne Vulgaris
Conditions
Keywords
Diet, glycemic index, glycemic load, Acne Vulgaris
Brief summary
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
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.
Interventions
Participants received a diet education on a low glycemic load diet.
OTHERUsual Eating Plan
Participants received a diet education to continue with their usual eating plan.
Sponsors
Nutrisystem, Inc.
New York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood glucose in mg/dL | Change from baseline blood glucose concentrations after two weeks. | A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure glucose concentrations |
| Insulin in uIL/mL | Change from baseline insulin concentrations after two weeks. | A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin concentrations |
| Insulin-like growth factor-1 in ng/mL | Change from baseline Insulin-like growth factor-1 concentrations after two weeks. | A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin-like growth factor-1 concentrations |
| Insulin-like growth factor binding protein-3 in mg/L | Change from baseline insulin-like growth factor binding protein-3 concentrations after two weeks. | A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin-like growth factor binding protein-3 concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Acne specific quality of life among participants following a low glycemic load diet or their usual diet for two weeks. | Change in baseline quality of life after 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in nutrition self efficacy among participants following a low glycemic load diet or their usual diet for two weeks | Change in nutrition self-efficacy after two-weeks. | Nutrition self-efficacy, or the ability to make diet changes, will be measured using a validated questionnaire. |
Outcome results
None listed