Fasting Meets Fitness: Unlocking the Synergy Between BW Protocol, Exercise, and Sleep Quality - A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Handgrip Strength
研究概览
简要总结
Type of Study: Clinical Trial
Goal: The goal of this clinical trial is to investigate whether combining the Buchinger Wilhelmi prolonged fasting program with a structured exercise program can improve physical fitness, body composition, cardiometabolic health, sleep quality, and health-related quality of life. The study will also investigate metabolic responses to prolonged fasting and whether these responses are influenced by exercise.
Participant Population/Health Conditions: The study will involve adults attending the Buchinger Wilhelmi Clinic who undergo the prolonged fasting program and meet the study eligibility criteria.
Main Questions:
- Does structured exercise performed before and/or during prolonged fasting enhance its effects on physical fitness, body composition, and cardiometabolic health?
- Does structured exercise improve sleep quality and health-related quality of life during prolonged fasting?
Participants Will:
- Undergo the Buchinger Wilhelmi prolonged fasting program.
- Choose whether to complete an online exercise program before the clinical stay and/or a supervised exercise program during fasting.
- Undergo physiological, physical fitness, and body composition assessments before and after the intervention.
- Provide blood samples to assess cardiometabolic and metabolic responses.
- Complete assessments of sleep and health-related quality of life.
Comparison Groups: Researchers will compare the four study conditions to determine whether structured exercise performed before and/or during prolonged fasting enhances the physiological, metabolic, and functional effects of the Buchinger Wilhelmi fasting program.
详细描述
Prolonged fasting induces substantial metabolic adaptations, including increased ketone body production and changes in glucose and lipid metabolism, and has been associated with improvements in cardiometabolic health and body composition. However, fasting may also be accompanied by fatigue, sleep disturbances, and changes in well-being that can affect physical function and quality of life during the intervention.
Exercise is a potent non-pharmacological strategy for improving physical fitness, body composition, cardiometabolic health, sleep, and quality of life. Combining exercise with prolonged fasting may provide complementary benefits by enhancing fasting-induced metabolic adaptations while helping to maintain physical function and well-being. The timing of exercise may also be relevant, as exercise performed before the fasting period may influence the physiological response to fasting, while exercise performed during fasting may directly interact with fasting-induced changes in substrate utilization and energy metabolism.
Based on this rationale, the main hypothesis is that structured exercise performed before and/or during prolonged fasting enhances the physiological and metabolic effects of fasting while improving physical fitness, sleep, and quality of life. The main objective is to determine the independent and combined effects of exercise performed before and during the Buchinger Wilhelmi prolonged fasting program on physical fitness, body composition, cardiometabolic health, sleep, and health-related quality of life.
The study will involve adults undergoing the Buchinger Wilhelmi prolonged fasting program as part of their clinical stay. Participants will choose whether to complete an online exercise program before attending the clinic and whether to participate in a supervised exercise program specifically designed for the fasting period during their clinical stay. These choices will result in four study conditions: (1) online exercise followed by prolonged fasting alone; (2) online exercise followed by prolonged fasting combined with supervised exercise; (3) prolonged fasting alone; and (4) prolonged fasting combined with supervised exercise. Allocation to these conditions will not be randomized. During fasting, participants will receive approximately 200-250 kcal/day and may participate in the activities routinely available at the clinic.
Before and after the intervention, participants will undergo physiological and physical fitness assessments. Blood samples will be collected to assess cardiometabolic and metabolic responses, including glucose and lipid metabolism and ketone production. Body composition will be assessed using bioelectrical impedance analysis, and physical fitness will include handgrip and lower-limb strength assessments. Sleep will be evaluated objectively using accelerometry and subjectively using the Pittsburgh Sleep Quality Index, while health-related quality of life will be assessed using the SF-36 questionnaire. These assessments are consistent with those specified in the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18-80 years.
- •Undergoing the Buchinger Wilhelmi prolonged fasting program at the Buchinger Wilhelmi Clinic in Marbella for at least 4 consecutive days.
- •Medically eligible to undergo prolonged fasting and to complete the study assessments.
- •For participants choosing an exercise condition, medically eligible to participate in the corresponding exercise program.
- •Able to understand the study procedures and provide written informed consent.
排除标准
- •Any medical condition or functional limitation that significantly restricts mobility or prevents safe completion of the study assessments or, when applicable, the exercise program.
- •Pregnancy or breastfeeding.
- •Cognitive or communication impairment that prevents adequate understanding of the study procedures or provision of informed consent.
- •Concurrent participation in another interventional study that could interfere with the study procedures or outcomes.
研究组 & 干预措施
Prolonged fasting
Participants will undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days without completing the study-specific online exercise program before the clinical stay or the supervised exercise program during fasting.
干预措施: Buchinger Wilhelmi prolonged fasting (Behavioral)
Prolonged fasting + supervised exercise
Participants will undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days and participate in the study-specific supervised exercise program during the fasting period. Participants will not complete the online exercise program before the clinical stay.
干预措施: Buchinger Wilhelmi prolonged fasting (Behavioral)
Prolonged fasting + supervised exercise
Participants will undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days and participate in the study-specific supervised exercise program during the fasting period. Participants will not complete the online exercise program before the clinical stay.
干预措施: Supervised exercise program during prolonged fasting (Behavioral)
Online exercise + prolonged fasting
Participants will complete a 21-day study-specific online exercise program before the clinical stay and subsequently undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days without participating in the supervised exercise program during fasting.
干预措施: Buchinger Wilhelmi prolonged fasting (Behavioral)
Online exercise + prolonged fasting
Participants will complete a 21-day study-specific online exercise program before the clinical stay and subsequently undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days without participating in the supervised exercise program during fasting.
干预措施: Online exercise program (Behavioral)
Online exercise + prolonged fasting + supervised exercise
Participants will complete a 21-day study-specific online exercise program before the clinical stay and subsequently undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days combined with the study-specific supervised exercise program during fasting.
干预措施: Buchinger Wilhelmi prolonged fasting (Behavioral)
Online exercise + prolonged fasting + supervised exercise
Participants will complete a 21-day study-specific online exercise program before the clinical stay and subsequently undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days combined with the study-specific supervised exercise program during fasting.
干预措施: Online exercise program (Behavioral)
Online exercise + prolonged fasting + supervised exercise
Participants will complete a 21-day study-specific online exercise program before the clinical stay and subsequently undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days combined with the study-specific supervised exercise program during fasting.
干预措施: Supervised exercise program during prolonged fasting (Behavioral)
结局指标
主要结局
Handgrip Strength
时间窗: Baseline and Day 4 to Day 28 (final fasting day, depending on participant)
Change from baseline in mean bilateral handgrip strength (kg) to the end of the fasting period, assessed using a handgrip dynamometer. For each hand, three trials will be performed and averaged. The mean values obtained for the right and left hands will then be averaged to obtain one bilateral handgrip strength value per participant.
次要结局
- Fasting Blood Glucose(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Fasting Insulin(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- LDL Cholesterol(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- HDL Cholesterol(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Triglycerides(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- C-Reactive Protein(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Five-Times Sit-to-Stand Test(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- 30-Second Sit-to-Stand Test(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Blood Lactate Response to the 30-Second Sit-to-Stand Test(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Total Body Fat Mass(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Body Fat Percentage(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Total Lean Mass(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Visceral Adipose Tissue Fat Mass(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Subcutaneous Adipose Tissue Fat Mass(Baseline and Day 4 to Day 28 (final fasting day, depending on participant))
- Physical Activity - International Physical Activity Questionnaire (IPAQ)(Baseline; Day 4 to Day 28 (final fasting day, depending on participant); and 30 days after the final fasting day)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline; Day 4 to Day 28 (final fasting day, depending on participant); and 30 days after the final fasting day)
- Health-Related Quality of Life - SF-36(Baseline; Day 4 to Day 28 (final fasting day, depending on participant); and 30 days after the final fasting day)
研究者
Borja Martínez Tellez
Principal Investigator
Universidad de Almeria