The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 主要终点
- Insulin in uIL/mL
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •> 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.
结局指标
主要结局
Insulin in uIL/mL
时间窗: 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
blood glucose in mg/dL
时间窗: 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-like growth factor binding protein-3 in mg/L
时间窗: 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
Insulin-like growth factor-1 in ng/mL
时间窗: 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
次要结局
- 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.)