A Single Arm Trial Investigating the Acute Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Blood glucose
研究概览
简要总结
The aim of this study is to investigate the effect of overnight fasting versus a diurnal fasting (during daily life activities) in females with and without obesity on inflammation, neurotrophins, energy metabolism, mood, food cravings, and appetite sensations.
This study will be an acute fasting intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.5 and 24.9 kg/m² or equal or greater 35 kg/m²;
- •Able to sign the informed consent.
排除标准
- •Chronic health conditions (e.g., cancer, renal, heart or liver disorders, and autoimmune diseases), or history of thyroid alterations or use of related medications;
- •Use of corticosteroids, immunosuppressors, anti-inflammatories, hypoglycemics, medications for weight loss, or any medication known to interfere with metabolic and inflammatory processes (e.g., corticosteroids, nonsteroidal anti-inflammatory drugs);
- •Previous surgery for weight loss;
- •Inability to eat any of the components of the standardized breakfast
- •Pregnancy or breastfeeding;
- •Alcohol use (>2 doses/day).
结局指标
主要结局
Blood glucose
时间窗: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in blood glucose will be assessed at baseline and after 10 hours of fasting during daily activities
Lipid panel
时间窗: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) will be assessed at baseline and after 10 hours of fasting during daily activities
Interleukin 6
时间窗: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in blood interleukin-6 will be assessed at baseline and after 10 hours of fasting during daily activities
Appetite sensations
时间窗: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in hunger, satiety, fullness, and prospective food consumption will be assessed at baseline and after 10 hours of fasting during daily activities using a 100 mm visual analogue scale
Mood states
时间窗: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in anger, confusion, depression, fatigue, tension, and vigor will be assessed using the Brunel Mood Scale
次要结局
- Gastrointestinal peptides(At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours))
- Free fatty acids(At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours))
- Neurotrophic factors(At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours))
研究者
Adaliene Versiani M. Ferreira
Principal Investigator, Associate Professor, PhD
Federal University of Minas Gerais