Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits (CoFFIe)
2 de julio de 2026 actualizado por: Buchinger Wilhelmi Development & Holding GmbH
This study builds on the knowledge that fasting provides metabolic health benefits and that prebiotic interventions can enhance the gut microbiome's metabolic output to likewise improve host health. Whether long-term fasting and dietary fibre interventions could be combined to achieve synergistic improvements in host metabolic health is however unknown. The goal is to provide a proof of concept in a human trial that supplementing 10±4 days fasting with dietary fibre synergistically improves metabolic outcomes via gut microbiome-mediated effects. To assess this, we aim to analyse gut microbiome changes, functional outputs, and key metabolic markers such as butyrate production, glycaemic control and ketosis.
The randomised controlled trial includes 75 participants and has two arms: one involving fasting with fibre supplementation (n = 50) and one involving fasting without fibre supplementation (n = 25). All participants will undergo a fasting period of 10±4 days according to the Buchinger Wilhelmi protocol, followed by a stepwise reintroduction of food of up to 4 days. As dietary fibre we will use maize-derived resistant starch type IV, selected based on its ability to stimulate beneficial gut microbes like Oscillibacter and corn starch as placebo. Two main visits will be conducted: before and at the end of the fasting period. During these visits, blood and stool samples will be collected, and questionnaires will be completed. Additionally, daily measurements of anthropometric parameters and well-being will be recorded. Stool samples will also be collected one month afterwards as a follow-up. Participants' metabolic health will be evaluated through various clinical parameters (e.g., body measurements, blood pressure, glycaemic control, ketones, well-being). Additionally, multi-omics data, including metagenomics and metabolomics, will provide insight into the composition of the microbiome, as well as its outputs and functions. Furthermore, the effects of fasting on extracellular vesicles in blood will be explored.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
75
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Elena Katharina Stroppel
- Número de teléfono: 00497551807675
- Correo electrónico: katharina.stroppel@buchinger-wilhelmi.com
Ubicaciones de estudio
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Baden-Wurttemberg
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Überlingen, Baden-Wurttemberg, Alemania, 88662
- Buchinger Wilhelmi Development & Holding
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Contacto:
- Elena Katharina Stroppel
- Número de teléfono: 00497551807675
- Correo electrónico: katharina.stroppel@buchinger-wilhelmi.com
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Contacto:
- Correo electrónico: forschung@buchinger-wilhelmi.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Men and women
- Age: 18-65 years old
- Fasting for 10±4 days at the Buchinger Wilhelmi clinic in Überlingen
- BMI ≥ 25 kg/m²
- Signed informed consent
Exclusion Criteria:
- intake of antibiotics up to 2 months prior the study
- regular intake of pre-, post- and probiotics up to 2 months prior the study
- diagnosed Crohn's disease, Ulcerative colitis, IBD, coeliac disease
- medicated high blood pressure
- diagnosed diabetes mellitus type I
- medicated diabetes mellitus type II
- diagnosed kidney stone
- active malignant disease
- known substance addiction
- pregnancy or breastfeeding
- diagnosed with cachexia, anorexia nervosa, advanced kidney, liver or cerebrovascular insufficiency
- inability to sign the informed consent
- participation in another study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Fibre Arm
Participants (n=50) undergo a 10±4-day fasting period according to the Buchinger Wilhelmi fasting programme and receive maize-derived resistant starch type IV at a total dose of 20 g per day.
The powder is blended into a carbohydrate-free electrolyte powder, divided into two equal daily doses, diluted in approximately 0.2 litres of water, and taken orally in the morning and at dinnertime throughout the fasting period.
The fasting period is followed by a structured food reintroduction period according to the standard procedure of the Buchinger Wilhelmi Clinic.
All other aspects of the intervention, including the fasting and nutritional protocol, clinical supervision, and study assessments, are identical to the control arm.
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10±4 days of fasting according to the Buchinger Wilhelmi fasting protocol, followed by a structured food reintroduction period, combined with 20 g/day of maize-derived resistant starch type IV.
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Comparador de placebos: Control Arm
Participants (n=25) undergo a 10±4-day fasting period according to the Buchinger Wilhelmi fasting programme and receive corn starch placebo at a total dose of 1.2 g per day.
The powder is blended into a carbohydrate-free electrolyte powder, divided into two equal daily doses, diluted in approximately 0.2 litres of water, and taken orally in the morning and at dinnertime throughout the fasting period.
The fasting period is followed by a structured food reintroduction period according to the standard procedure of the Buchinger Wilhelmi Clinic.
All other aspects of the intervention, including the fasting and nutritional protocol, clinical supervision, and study assessments, are identical to the intervention arm.
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10±4 days of fasting according to the Buchinger Wilhelmi fasting protocol, followed by a structured food reintroduction period, combined with 1.2 g/day of corn starch placebo.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Abundance of butyrate-producing gut bacteria
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in the relative abundance of butyrate-producing gut bacteria assessed by metagenomic profiling of faecal samples.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in fasting venous plasma glucose
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Fasting venous plasma glucose concentration measured by clinical laboratory analysis (mmol/L).
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in body weight
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Body weight (kg) measured as part of the clinical health assessment.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in body mass index
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Body mass index calculated from measured body weight and height (kg/m²).
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in waist circumference
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Waist circumference (cm) measured as part of the clinical health assessment.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in HbA1c
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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HbA1c (mmol/mol) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in HOMA index
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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HOMA index calculated from fasting plasma glucose and fasting insulin concentrations.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in fasting venous insulin
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Fasting venous insulin concentration (pmol/L) measured by clinical laboratory analysis.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in glycaemic control assessed by continuous glucose monitoring
Periodo de tiempo: From Day 1 through Day 14
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Glycaemic control assessed by blinded continuous glucose monitoring using the FreeStyle Libre 3 system, with glucose values recorded at 1-minute intervals (mmol/L).
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From Day 1 through Day 14
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the abundance of butyrate-producing gut bacteria
Periodo de tiempo: Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
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Exploratory assessment of the change in the abundance of butyrate-producing gut bacteria, derived from metagenomic profiling.
Additional unscheduled samples may be collected during fasting if spontaneous bowel movements occur.
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Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
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Change in body weight
Periodo de tiempo: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
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Exploratory assessment of change in body weight (kg)
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Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
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Change in body mass index
Periodo de tiempo: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
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Exploratory assessment of change in body mass index (kg/m²).
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Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
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Change in glycaemic control assessed by continuous glucose monitoring
Periodo de tiempo: From day 15 through day 28
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Exploratory assessment of change in glycaemic control during the post-fasting follow-up period, assessed by open-label continuous glucose monitoring.
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From day 15 through day 28
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Change in gut microbiome composition and functional output
Periodo de tiempo: Baseline, end of the 10±4-day fasting period, and 1 month after fasting
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Change in gut microbiome composition and functional output from baseline and the end of the fasting period to the one-month follow-up, assessed by metagenomics, metatranscriptomics, metabolomics, and short-chain fatty acid analysis.
Additional unscheduled samples may be collected during fasting if spontaneous bowel movements occur
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Baseline, end of the 10±4-day fasting period, and 1 month after fasting
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Height
Periodo de tiempo: at baseline
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Measurement of body height (cm)
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at baseline
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Changes in resting blood pressure
Periodo de tiempo: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
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Resting systolic blood pressure (mmHg) and resting diastolic blood pressure (mmHg) measured as part of the clinical health assessment and as self-measurement at follow-up.
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Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
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Change in heart rate
Periodo de tiempo: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
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Heart rate (beats/min) measured as part of the clinical health assessment and as self-measurement at follow-up.
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Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
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Change in leucocyte count
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in leucocyte count (10⁹/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in erythrocyte count
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in erythrocyte count (10¹²/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in haemoglobin concentration
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in haemoglobin concentration (g/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in haematocrit
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in haematocrit levels (L/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in mean corpuscular volume (MCV)
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in mean corpuscular volume (fL) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in mean corpuscular haemoglobin (MCH)
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in mean corpuscular haemoglobin (pg) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in mean corpuscular haemoglobin concentration (MCHC)
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in mean corpuscular haemoglobin concentration (g/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in thrombocyte count
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in thrombocyte count (10⁹/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in lymphocyte count
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in lymphocyte count (10⁹/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in international normalized ratio (INR)
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in international normalized ratio (dimensionless) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in Quick value
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in Quick value (%) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in partial thromboplastin time (PTT)
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in partial thromboplastin time (seconds) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Changes in liver parameters
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Liver-related parameters measured by clinical laboratory analysis of venous blood: aspartate aminotransferase (U/L), alanine aminotransferase (U/L), gamma-glutamyl transferase (U/L), and alkaline phosphatase (U/L).
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in uric acid
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in uric acid levels (µmol/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in urea
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in urea levels (mmol/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in creatinine
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in creatinine levels (µmol/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in estimated glomerular filtration rate (eGFR)
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in estimated glomerular filtration rate (mL/min/1.73
m²) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Changes in lipid parameters
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Lipid parameters measured by clinical laboratory analysis of venous blood: total cholesterol (mmol/L), triglycerides (mmol/L), high-density lipoprotein cholesterol (mmol/L), low-density lipoprotein cholesterol (mmol/L), and non-high-density lipoprotein cholesterol (mmol/L).
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Changes in serum electrolyte concentrations
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Electrolyte concentrations measured by clinical laboratory analysis of venous blood: sodium (mmol/L), potassium (mmol/L), calcium (mmol/L), and magnesium (mmol/L).
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in high-sensitivity C-reactive protein
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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High-sensitivity C-reactive protein concentration (mg/L) measured by clinical laboratory analysis of venous blood.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in extracellular vesicle size
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in extracellular vesicle size (nm) derived from the analysis of venous blood samples.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in extracellular vesicle concentration
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in extracellular vesicle concentration (particles/mL) derived from the analysis of venous blood samples.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in extracellular vesicle cargo profile
Periodo de tiempo: Baseline (T0) and end of the 10±4-day fasting period (T1)
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Change in extracellular vesicle cargo profile derived from the analysis of venous blood samples.
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Baseline (T0) and end of the 10±4-day fasting period (T1)
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Changes in urinary acetoacetic acid
Periodo de tiempo: Baseline (T0) and daily during the 10±4-day fasting period and food reintroduction period
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Acetoacetic acid measured in urine as a biomarker of ketosis.
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Baseline (T0) and daily during the 10±4-day fasting period and food reintroduction period
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Change in WHO-5 well-being index
Periodo de tiempo: Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
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Change in WHO-5 (score: 0-100)
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Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
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Changes in self-reported gut health and symptoms
Periodo de tiempo: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
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Questionnaire-based assessment of gastrointestinal and systemic symptoms using a 0-to-10 numerical rating scale (where 0 = none/not full and 10 = very strong/very full).
Symptoms assessed include hunger, bloating/fullness, flatulence, abdominal discomfort/pain, nausea, heartburn, acid regurgitation, cravings, fatigue, headache, and sleep disturbances.
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Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
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Change in self-reported physical activity
Periodo de tiempo: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
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Change in physical activity level (hours/day) assessed by online questionnaires.
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Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
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Change in self-reported physical activity
Periodo de tiempo: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
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Change in physical activity level (VAS 0-10) assessed by online questionnaires.
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Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
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Change in self-reported well-being
Periodo de tiempo: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
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Change in self-reported physical and emotional well-being (VAS 0-10) as well as energy level (VAS 0-10) assessed by online questionnaires.
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Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
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Occurrence of adverse effects
Periodo de tiempo: Through study completion, an average of 7 weeks
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Number and characteristics of possible adverse effects assessed from participant reports and documentation by the study physician, including seriousness and possible relationship to the study intervention.
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Through study completion, an average of 7 weeks
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Smoking behavior
Periodo de tiempo: baseline
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status: never, former, current
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baseline
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Confounding medical events and medication
Periodo de tiempo: Baseline (T0) and 1 month after fasting (T2)
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Number of participants reporting concomitant medication use, supplement intake, or medical interventions (including antibiotics, prebiotics, probiotics, postbiotics, dietary supplements, hormonal therapies, surgeries, gastrointestinal endoscopies, or hospitalizations).
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Baseline (T0) and 1 month after fasting (T2)
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Dietary patterns
Periodo de tiempo: Baseline (T0) and 1 month after fasting (T2)
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Number of participants practicing specific dietary patterns (including omnivorous, flexitarian, pescetarian, vegetarian, vegan, or other specific diets like ketogenic).
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Baseline (T0) and 1 month after fasting (T2)
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Change in intake of specific food categories
Periodo de tiempo: Baseline (T0) and 1 month after fasting (T2)
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Questionnaire-based assessment of dietary fiber and fermented food intake (measured in portions per day or week) across specific food categories, including fruit, vegetables, bread and grain products, nuts and seeds, legumes, and fermented foods.
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Baseline (T0) and 1 month after fasting (T2)
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Change in alcohol consumption
Periodo de tiempo: Baseline (T0) and 1 month after fasting (T2)
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Questionnaire-based assessment of average weekly alcohol consumption (measured in standard glasses per week) across specific beverage types, including wine, beer, and spirits.
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Baseline (T0) and 1 month after fasting (T2)
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Change in stool consistency
Periodo de tiempo: Baseline (T0) and 1 month after fasting (T2)
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Change in usual stool consistency measured by the Bristol Stool Chart (Type 1 to Type 7; coded as an ordinal category).
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Baseline (T0) and 1 month after fasting (T2)
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Change in bowel movement frequency
Periodo de tiempo: Baseline (T0) and 1 month after fasting (T2)
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Change in typical bowel movement frequency categorized into four ordinal levels (from 1-2 times per week up to more than 3 times per day)
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Baseline (T0) and 1 month after fasting (T2)
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Change in general gut health rating
Periodo de tiempo: Baseline (T0) and 1 month after fasting (T2)
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Change in subjective general gut health rated on a 0-to-10 numerical rating scale (where 0 = very poor and 10 = excellent).
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Baseline (T0) and 1 month after fasting (T2)
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Initial laxative methods
Periodo de tiempo: End of the 10±4-day fasting period (T1)
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Number of participants utilizing specific laxative methods at the beginning of the fasting period (including Glauber's salt, Laxoberal, enemas, other laxatives, or no laxative use).
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End of the 10±4-day fasting period (T1)
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Palatability of the dietary fiber supplement
Periodo de tiempo: End of the 10±4-day fasting period (T1)
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Subjective taste rating of the dietary fiber supplement measured on a 7-point Likert scale (from "not at all" to "very good").
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End of the 10±4-day fasting period (T1)
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Perceived change in digestion during fiber supplementation
Periodo de tiempo: End of the 10±4-day fasting period (T1)
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Participant-reported change in digestion during the supplementation period, measured on a 7-point Likert scale (from "very negative" to "very positive").
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End of the 10±4-day fasting period (T1)
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Tolerability of the dietary fiber supplement
Periodo de tiempo: End of the 10±4-day fasting period (T1)
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Subjective tolerability rating of the dietary fiber supplement measured on a 7-point Likert scale (from "very poorly" to "very well").
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End of the 10±4-day fasting period (T1)
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Intervention compliance
Periodo de tiempo: Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
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Compliance with the dietary fiber supplementation protocol, calculated as the percentage of prescribed doses successfully consumed (both morning and evening doses) during the fasting and food reintroduction periods, as verified by participant daily logs.
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Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
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Utilization of optional supplements during fasting
Periodo de tiempo: Daily during the 10±4-day fasting period (Day 1 through end of fasting (T1))
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Tracking the consumption of optional dietary additions permitted within the fasting protocol.
This includes the number of participants choosing to consume midday juice, honey, or other additions (such as yogurt, Kousmine cream, oatmeal, or carrot juice).
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Daily during the 10±4-day fasting period (Day 1 through end of fasting (T1))
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Daily bowel movement occurrence and induction method
Periodo de tiempo: Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
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Number of participants reporting a bowel movement each day, categorized by the method of clearance (none, spontaneous, induced by enema, induced by colon hydrotherapy, or induced by laxatives).
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Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
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Daily spontaneous stool consistency
Periodo de tiempo: Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
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Daily assessment of stool consistency for participants with spontaneous bowel movements, scored using the Bristol Stool Chart (Type 1 to Type 7; analyzed as daily ordinal categories or mean scores).
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Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
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Daily fluid intake
Periodo de tiempo: Daily during the 10±4-day fasting period and food reintroduction period
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Daily self-reported volume of water or herbal tea consumed by participants, measured in liters (L).
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Daily during the 10±4-day fasting period and food reintroduction period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Andrea Siegler, Dr. med., Buchinger Wilhelmi Development & Holding
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
28 de febrero de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
24 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de julio de 2026
Publicado por primera vez (Actual)
9 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- F-2026-010
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .