Clinical trial NCT02913001: The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
Official title: The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: Diet
glycemic index
glycemic load
Acne Vulgaris
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Nutrisystem, Inc.
First posted: 2016-09-23
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: blood glucose in mg/dL
timeFrame: Change from baseline blood glucose concentrations after two weeks.
measure: Insulin in uIL/mL
timeFrame: Change from baseline insulin concentrations after two weeks.
measure: Insulin-like growth factor-1 in ng/mL
timeFrame: Change from baseline Insulin-like growth factor-1 concentrations after two weeks.
measure: Insulin-like growth factor binding protein-3 in mg/L
timeFrame: Change from baseline insulin-like growth factor binding protein-3 concentrations after two weeks.
Secondary outcomes:
measure: Changes in Acne specific quality of life among participants following a low glycemic load diet or their usual diet for two weeks.
timeFrame: Change in baseline quality of life after two weeks.
Other outcomes:
measure: Changes in nutrition self efficacy among participants following a low glycemic load diet or their usual diet for two weeks
timeFrame: Change in nutrition self-efficacy after two-weeks.
Locations:
Study officials:
affiliation: New York University
name: Kathleen Woolf, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Jennifer Burris, PhD
role: STUDY_DIRECTOR
References:
citation: Burris J, Rietkerk W, Woolf K. Acne: the role of medical nutrition therapy. J Acad Nutr Diet. 2013 Mar;113(3):416-430. doi: 10.1016/j.jand.2012.11.016.
citation: Burris J, Shikany JM, Rietkerk W, Woolf K. A Low Glycemic Index and Glycemic Load Diet Decreases Insulin-like Growth Factor-1 among Adults with Moderate and Severe Acne: A Short-Duration, 2-Week Randomized Controlled Trial. J Acad Nutr Diet. 2018 Oct;118(10):1874-1885. doi: 10.1016/j.jand.2018.02.009. Epub 2018 Apr 22.