Effects of the Buchinger Wilhelmi Fasting Program and Exercise on Physical Fitness and Sleep Quality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversidad de Almeria
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Buchinger Wilhelmi prolonged fasting
BehavioralParticipants will undergo the medically supervised Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days. During fasting, participants will receive approximately 200-250 kcal/day, primarily from vegetable juices and vegetable broth, together with non-caloric fluids.
Online exercise program
BehavioralParticipants will complete a 21-day study-specific remotely delivered exercise program before admission to the Buchinger Wilhelmi Clinic. The program provides structured exercise training before the prolonged fasting period.
Supervised exercise program during prolonged fasting
BehavioralParticipants will complete a study-specific supervised exercise program during the prolonged fasting period at the Buchinger Wilhelmi Clinic. Exercise sessions will be conducted under professional supervision and adapted to participants' individual physical capacity.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Prolonged fastingExperimental treatment 1 intervention
Group B: Prolonged fasting + supervised exerciseExperimental treatment 2 interventions
Group C: Online exercise + prolonged fastingExperimental treatment 2 interventions
Group D: Online exercise + prolonged fasting + supervised exerciseExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Handgrip Strength
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.
Time frame
Baseline and Day 4 to Day 28 (final fasting day, depending on participant)Secondary outcomes
1
Fasting Blood Glucose
Change in fasting blood glucose concentration (mg/dL) from baseline to the end of the fasting period.
Time frame
Baseline and Day 4 to Day 28 (final fasting day, depending on participant)2
Fasting Insulin
Change in fasting insulin concentration (µIU/mL) from baseline to the end of the fasting period.
Time frame
Baseline and Day 4 to Day 28 (final fasting day, depending on participant)3
LDL Cholesterol
Change in low-density lipoprotein cholesterol concentration (mg/dL) from baseline to the end of the fasting period.
Time frame
Baseline and Day 4 to Day 28 (final fasting day, depending on participant)4
HDL Cholesterol
Change in high-density lipoprotein cholesterol concentration (mg/dL) from baseline to the end of the fasting period.
Time frame
Baseline and Day 4 to Day 28 (final fasting day, depending on participant)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad de Almeria
Lead sponsor
Buchinger Wilhelmi Development & Holding GmbH
Collaborator
Source ClinicalTrials.gov
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