Feasibility and Effects of a 5 Day Home Based Fasting Intervention in University Students: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- feasibility of the fasting protocol and any adverse events reported during the intervention.Feasibility will be determined by examining adherence rates, participant retention, and overall satisfaction with the fasting protocol. Additionally, safety will be evaluated by monitoring any adverse events or fasting crisis symptoms.
研究概览
简要总结
Study Title:Feasibility and Effects of a 5-Day Home-Based Fasting Intervention in University Students: A Pilot Study
Study Design:This is a cluster-randomized, waitlist-controlled pilot trial aimed at assessing the feasibility, safety, and preliminary physiological and psychological effects of a 5-day home-based fasting intervention in university students.
Study Objectives:
- Primary Objective: To evaluate the feasibility and safety of a 5-day home-based fasting protocol among university students.
- Secondary Objectives:
- To assess physiological outcomes, including changes in body weight, body mass index (BMI), waist circumference, blood glucose, and ketone levels.
- To evaluate psychological well-being, focusing on mood, stress, and emotional well-being, using validated questionnaires.
Inclusion Criteria:
- University students aged 18-30 years.
- Generally healthy (no chronic diseases).
- Willingness to adhere to the 5-day fasting protocol.
- Access to the internet for self-reporting and virtual monitoring.
Exclusion Criteria:
- Diagnosed with metabolic disorders, cardiovascular conditions, or gastrointestinal diseases.
- Pregnant or lactating women.
- History of eating disorders or severe mental health conditions.
- Currently taking medications affecting metabolism or appetite.
Intervention:Participants in the intervention group will follow a 5-day fasting protocol at home, including a transition day, 3 days of liquid fasting, and a reintroduction day. The waitlist control group will begin fasting after the first group completes the intervention.
Sample Size:Approximately 30 university students, with two clusters of 20 each (one intervention, one control).
Outcomes:
- Primary Outcomes:
- Feasibility based on adherence rates (≥80%) and retention (≤30% dropout).
- Safety is assessed by adverse events and blood glucose monitoring.
- Secondary Outcomes:
- Changes in weight, BMI, and blood glucose/ketone levels.
- Emotional well-being and psychological health were assessed through self-reports.
Duration:The study will last for 5 days, with follow-up assessments post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: Participants must be between 18 and 30 years old.
- •Enrollment: Must be currently enrolled as a university student.
- •Willingness to fast: Participants must express a willingness to adhere to a 5-day fasting protocol, including the transition, liquid fasting, and reintroduction phases.
- •Health Status: Must be generally healthy, as indicated by self-reported medical history (no significant chronic illnesses such as diabetes, heart disease, or other metabolic conditions).
- •Internet Access: Must have access to a smartphone or computer with internet for monitoring, virtual check-ins, and self-reporting via surveys or apps.
- •Informed Consent: Must provide written informed consent to participate in the study and agree to comply with the study protocol, including daily monitoring of physiological and psychological outcomes.
- •Body Mass Index (BMI): Participants should have a BMI between 18.5 and 29.9 kg/m² (healthy or overweight range).
排除标准
- •Existing Medical Conditions: Any diagnosed metabolic disorders (e.g., diabetes, thyroid disease), cardiovascular conditions, or gastrointestinal diseases that could be negatively affected by fasting.
- •Pregnancy or Lactation: Pregnant or breastfeeding women will be excluded for safety reasons.
- •Eating Disorders: A current or past diagnosis of any eating disorder, such as anorexia, bulimia, or binge-eating disorder.
- •Medication Use: Regular use of medication that affects metabolism, blood sugar, or appetite (e.g., insulin, corticosteroids, appetite suppressants).
- •Allergies or Food Intolerances: Any severe allergies or intolerances to foods included in the fasting or reintroduction protocols (e.g., vegetable broths, olive oil, ghee, coconut oil).
- •Recent Major Surgery or Injury: Participants who have undergone surgery or suffered a major injury in the past 3 months that may interfere with fasting or physical well-being.
- •Smoking or Alcohol Abuse: Regular smokers or those with a history of substance or alcohol abuse in the past 6 months.
- •Participation in Other Studies: Concurrent participation in another clinical trial or health intervention that may interfere with fasting outcomes or data collection.
结局指标
主要结局
feasibility of the fasting protocol and any adverse events reported during the intervention.Feasibility will be determined by examining adherence rates, participant retention, and overall satisfaction with the fasting protocol. Additionally, safety will be evaluated by monitoring any adverse events or fasting crisis symptoms.
时间窗: Daily for 5 days during the intervention in both control and intervention group.
次要结局
- weight, BMI, & blood glucose, ketone bodies.(daily self-reports of stress, anxiety, & mood)
研究者
Dr Ruchika Golani
SGT University