Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits (CoFFIe)
2 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
75
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Elena Katharina Stroppel
- Telefoonnummer: 00497551807675
- E-mail: katharina.stroppel@buchinger-wilhelmi.com
Studie Locaties
-
-
Baden-Wurttemberg
-
Überlingen, Baden-Wurttemberg, Duitsland, 88662
- Buchinger Wilhelmi Development & Holding
-
Contact:
- Elena Katharina Stroppel
- Telefoonnummer: 00497551807675
- E-mail: katharina.stroppel@buchinger-wilhelmi.com
-
Contact:
- E-mail: forschung@buchinger-wilhelmi.com
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
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.
|
|
Placebo-vergelijker: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Abundance of butyrate-producing gut bacteria
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in the relative abundance of butyrate-producing gut bacteria assessed by metagenomic profiling of faecal samples.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in fasting venous plasma glucose
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Fasting venous plasma glucose concentration measured by clinical laboratory analysis (mmol/L).
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in body weight
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Body weight (kg) measured as part of the clinical health assessment.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in body mass index
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Body mass index calculated from measured body weight and height (kg/m²).
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in waist circumference
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Waist circumference (cm) measured as part of the clinical health assessment.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in HbA1c
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
HbA1c (mmol/mol) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in HOMA index
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
HOMA index calculated from fasting plasma glucose and fasting insulin concentrations.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in fasting venous insulin
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Fasting venous insulin concentration (pmol/L) measured by clinical laboratory analysis.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in glycaemic control assessed by continuous glucose monitoring
Tijdsspanne: From Day 1 through Day 14
|
Glycaemic control assessed by blinded continuous glucose monitoring using the FreeStyle Libre 3 system, with glucose values recorded at 1-minute intervals (mmol/L).
|
From Day 1 through Day 14
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in the abundance of butyrate-producing gut bacteria
Tijdsspanne: Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
|
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.
|
Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
|
|
Change in body weight
Tijdsspanne: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
|
Exploratory assessment of change in body weight (kg)
|
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
|
|
Change in body mass index
Tijdsspanne: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
|
Exploratory assessment of change in body mass index (kg/m²).
|
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
|
|
Change in glycaemic control assessed by continuous glucose monitoring
Tijdsspanne: From day 15 through day 28
|
Exploratory assessment of change in glycaemic control during the post-fasting follow-up period, assessed by open-label continuous glucose monitoring.
|
From day 15 through day 28
|
|
Change in gut microbiome composition and functional output
Tijdsspanne: Baseline, end of the 10±4-day fasting period, and 1 month after fasting
|
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
|
Baseline, end of the 10±4-day fasting period, and 1 month after fasting
|
|
Height
Tijdsspanne: at baseline
|
Measurement of body height (cm)
|
at baseline
|
|
Changes in resting blood pressure
Tijdsspanne: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
|
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.
|
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
|
|
Change in heart rate
Tijdsspanne: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
|
Heart rate (beats/min) measured as part of the clinical health assessment and as self-measurement at follow-up.
|
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
|
|
Change in leucocyte count
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in leucocyte count (10⁹/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in erythrocyte count
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in erythrocyte count (10¹²/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in haemoglobin concentration
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in haemoglobin concentration (g/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in haematocrit
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in haematocrit levels (L/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in mean corpuscular volume (MCV)
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in mean corpuscular volume (fL) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in mean corpuscular haemoglobin (MCH)
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in mean corpuscular haemoglobin (pg) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in mean corpuscular haemoglobin concentration (MCHC)
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in mean corpuscular haemoglobin concentration (g/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in thrombocyte count
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in thrombocyte count (10⁹/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in lymphocyte count
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in lymphocyte count (10⁹/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in international normalized ratio (INR)
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in international normalized ratio (dimensionless) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in Quick value
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in Quick value (%) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in partial thromboplastin time (PTT)
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in partial thromboplastin time (seconds) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Changes in liver parameters
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
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).
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in uric acid
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in uric acid levels (µmol/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in urea
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in urea levels (mmol/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in creatinine
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in creatinine levels (µmol/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in estimated glomerular filtration rate (eGFR)
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in estimated glomerular filtration rate (mL/min/1.73
m²) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Changes in lipid parameters
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
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).
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Changes in serum electrolyte concentrations
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Electrolyte concentrations measured by clinical laboratory analysis of venous blood: sodium (mmol/L), potassium (mmol/L), calcium (mmol/L), and magnesium (mmol/L).
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in high-sensitivity C-reactive protein
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
High-sensitivity C-reactive protein concentration (mg/L) measured by clinical laboratory analysis of venous blood.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in extracellular vesicle size
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in extracellular vesicle size (nm) derived from the analysis of venous blood samples.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in extracellular vesicle concentration
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in extracellular vesicle concentration (particles/mL) derived from the analysis of venous blood samples.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Change in extracellular vesicle cargo profile
Tijdsspanne: Baseline (T0) and end of the 10±4-day fasting period (T1)
|
Change in extracellular vesicle cargo profile derived from the analysis of venous blood samples.
|
Baseline (T0) and end of the 10±4-day fasting period (T1)
|
|
Changes in urinary acetoacetic acid
Tijdsspanne: Baseline (T0) and daily during the 10±4-day fasting period and food reintroduction period
|
Acetoacetic acid measured in urine as a biomarker of ketosis.
|
Baseline (T0) and daily during the 10±4-day fasting period and food reintroduction period
|
|
Change in WHO-5 well-being index
Tijdsspanne: Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
|
Change in WHO-5 (score: 0-100)
|
Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
|
|
Changes in self-reported gut health and symptoms
Tijdsspanne: 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)
|
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.
|
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)
|
|
Change in self-reported physical activity
Tijdsspanne: 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)
|
Change in physical activity level (hours/day) assessed by online questionnaires.
|
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)
|
|
Change in self-reported physical activity
Tijdsspanne: 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)
|
Change in physical activity level (VAS 0-10) assessed by online questionnaires.
|
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)
|
|
Change in self-reported well-being
Tijdsspanne: 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)
|
Change in self-reported physical and emotional well-being (VAS 0-10) as well as energy level (VAS 0-10) assessed by online questionnaires.
|
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)
|
|
Occurrence of adverse effects
Tijdsspanne: Through study completion, an average of 7 weeks
|
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.
|
Through study completion, an average of 7 weeks
|
|
Smoking behavior
Tijdsspanne: baseline
|
status: never, former, current
|
baseline
|
|
Confounding medical events and medication
Tijdsspanne: Baseline (T0) and 1 month after fasting (T2)
|
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).
|
Baseline (T0) and 1 month after fasting (T2)
|
|
Dietary patterns
Tijdsspanne: Baseline (T0) and 1 month after fasting (T2)
|
Number of participants practicing specific dietary patterns (including omnivorous, flexitarian, pescetarian, vegetarian, vegan, or other specific diets like ketogenic).
|
Baseline (T0) and 1 month after fasting (T2)
|
|
Change in intake of specific food categories
Tijdsspanne: Baseline (T0) and 1 month after fasting (T2)
|
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.
|
Baseline (T0) and 1 month after fasting (T2)
|
|
Change in alcohol consumption
Tijdsspanne: Baseline (T0) and 1 month after fasting (T2)
|
Questionnaire-based assessment of average weekly alcohol consumption (measured in standard glasses per week) across specific beverage types, including wine, beer, and spirits.
|
Baseline (T0) and 1 month after fasting (T2)
|
|
Change in stool consistency
Tijdsspanne: Baseline (T0) and 1 month after fasting (T2)
|
Change in usual stool consistency measured by the Bristol Stool Chart (Type 1 to Type 7; coded as an ordinal category).
|
Baseline (T0) and 1 month after fasting (T2)
|
|
Change in bowel movement frequency
Tijdsspanne: Baseline (T0) and 1 month after fasting (T2)
|
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)
|
Baseline (T0) and 1 month after fasting (T2)
|
|
Change in general gut health rating
Tijdsspanne: Baseline (T0) and 1 month after fasting (T2)
|
Change in subjective general gut health rated on a 0-to-10 numerical rating scale (where 0 = very poor and 10 = excellent).
|
Baseline (T0) and 1 month after fasting (T2)
|
|
Initial laxative methods
Tijdsspanne: End of the 10±4-day fasting period (T1)
|
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).
|
End of the 10±4-day fasting period (T1)
|
|
Palatability of the dietary fiber supplement
Tijdsspanne: End of the 10±4-day fasting period (T1)
|
Subjective taste rating of the dietary fiber supplement measured on a 7-point Likert scale (from "not at all" to "very good").
|
End of the 10±4-day fasting period (T1)
|
|
Perceived change in digestion during fiber supplementation
Tijdsspanne: End of the 10±4-day fasting period (T1)
|
Participant-reported change in digestion during the supplementation period, measured on a 7-point Likert scale (from "very negative" to "very positive").
|
End of the 10±4-day fasting period (T1)
|
|
Tolerability of the dietary fiber supplement
Tijdsspanne: End of the 10±4-day fasting period (T1)
|
Subjective tolerability rating of the dietary fiber supplement measured on a 7-point Likert scale (from "very poorly" to "very well").
|
End of the 10±4-day fasting period (T1)
|
|
Intervention compliance
Tijdsspanne: Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
|
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.
|
Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
|
|
Utilization of optional supplements during fasting
Tijdsspanne: Daily during the 10±4-day fasting period (Day 1 through end of fasting (T1))
|
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).
|
Daily during the 10±4-day fasting period (Day 1 through end of fasting (T1))
|
|
Daily bowel movement occurrence and induction method
Tijdsspanne: Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
|
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).
|
Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
|
|
Daily spontaneous stool consistency
Tijdsspanne: Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
|
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).
|
Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
|
|
Daily fluid intake
Tijdsspanne: Daily during the 10±4-day fasting period and food reintroduction period
|
Daily self-reported volume of water or herbal tea consumed by participants, measured in liters (L).
|
Daily during the 10±4-day fasting period and food reintroduction period
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Andrea Siegler, Dr. med., Buchinger Wilhelmi Development & Holding
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
28 februari 2027
Studie voltooiing (Geschat)
1 maart 2027
Studieregistratiedata
Eerst ingediend
24 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
2 juli 2026
Eerst geplaatst (Werkelijk)
9 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
2 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- F-2026-010
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .