Comparison of Intermittent Fasting Interventions on Brain Health in Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Depression, Anxiety and Stress Scale (DASS-21) Questionnaire - Stress Sub-Scale
研究概览
简要总结
Adults experience high psychological stress due to many factors such as school, workplace, or personal life. Adult women are known to experience higher stress levels than men. Current evidence shows that fasting improves mental health outcomes in men. The research is unclear on fasting interventions and their potential impact on stress levels in women. In this study, investigators will compare two fasting diets over 8 weeks. There will be a control group, one group that fasts for two days per week, and a final group that only eats for 8 hours in the morning. Mental health surveys, brain tests and a blood draw will be done during the study to see any mental or physical changes from the diets. Investigators will study the motivation of women to continue the diet during and beyond the study through online surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English speaker
- •Assignment of female sex at birth
- •BMI between 18.5-24.9 kg/m^2
- •Current engagement in less than 150 minutes of physical activity per week
- •Normal menstrual cycle length (21-40 days) for at least 3 months
- •Non-smoker
- •Consumption of no more than one alcoholic beverage per day
- •Mild to higher levels of stress as indicated by a score of 15 or higher on the stress sub-set of the DASS-21 questionnaire
- •Exclusion criteria:
- •Pregnant or breastfeeding
- •Diagnosed chronic disease (cardiovascular, metabolic, respiratory, reproductive, renal, neuromuscular, or any other disease or condition as assessed by the Canadian Society for Exercise Physiology Get Active Questionnaire)
- •Diagnosed eating disorder
- •Participation in a weight-loss program in the last 3 months
- •Loss of 5% of body weight or more in the last 3 months
排除标准
- 未提供
结局指标
主要结局
Depression, Anxiety and Stress Scale (DASS-21) Questionnaire - Stress Sub-Scale
时间窗: 8 weeks
Investigators will administer the standardized DASS-21 Questionnaire at Week 0 and Week 8. The stress sub-scale will be used to measure any potential effects of fasting interventions on psychological stress over time. The scoring of answers is based on a 0 to 3 scale. 3 reflects the negative extreme on the Likert Scale. Scores range from 0-42, higher scores are indicative of higher psychological stress levels.
次要结局
- Eating Disorder Examination Questionnaire (EDE-Q 6.0)(8 weeks)
- Profile of Mood States (POMS)(8 weeks)
- Weight (kg)(8 weeks)
- Waist Circumference (cm)(8 weeks)
- Inflammatory Biomarker C-Reactive Protein [CRP] (mg/L)(8 weeks)
- Colour and Word Stroop Test (SCWT)(8 weeks)
- Mnemonic Similarity Task (MST)(8 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(8 weeks)
- Inflammatory Biomarker Interleukin-6 [IL6] (pg/mL)(8 weeks)
- Body Composition (Lean Body Mass - kg)(8 weeks)
- State Anxiety Inventory (STAI) Short Form(8 weeks)
- Blood Pressure(8 weeks)
- Inflammatory Biomarker Tumour Necrosis Factor Alpha [TNF-a] (pg/mL)(8 weeks)
- Blood Ketone Levels (mmol/L)(8 weeks)
- Body Mass Index (BMI)(8 weeks)
- Pregnancy Status(One time measure at Week 0)
- Five Facet Mindfulness Questionnaire (FFMQ)(8 weeks)
- Height (cm)(8 weeks)
- Blood Glucose Levels (mmol/L)(8 weeks)
- Body Composition (% Body Fat)(8 weeks)
- Diet Satisfaction & Adherence Questionnaire(8 weeks)