MedPath

Physiological Response to 5 Days Fasting

Not Applicable
Completed
Conditions
Healthy
Interventions
Other: Buchinger fasting
Registration Number
NCT04452916
Lead Sponsor
Charite University, Berlin, Germany
Brief Summary

To investigate energy metabolism, anthropometry, blood pressure, gut microbiome, serum metabolome, glucose variability and neural mechanisms of food choice and mood before and after 5 days of fasting as well as their persistence in healthy men and women.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
55
Inclusion Criteria
  • Men and women
  • 20-50 years
  • Body mass index 20-30 kg/m2
Exclusion Criteria
  • Clinically relevant heart, lung, liver, and kidney diseases
  • Any prescribed medication (except for oral contraceptives)
  • Current or chronic infection
  • Intake of antibiotics within 6 months before study entry
  • Fasting week within 6 months before study entry
  • Habitual use of dietary supplements
  • Food intolerances
  • Pregnancy, lactation
  • Vegan diet
  • Smokers
  • In addition for fMRI: sensorineural hearing loss, tinnitus, metal implants, electric devices

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
FastingBuchinger fastingStarts immediately with 5 days of Buchinger fasting
Waiting list controlBuchinger fastingStarts with 5 days of Buchinger fasting after a waiting period of 12 weeks
Primary Outcome Measures
NameTimeMethod
Resting Energy Expenditure6-th day of fasting compared to baseline

Measured by indirect calorimetry (kcal/d)

Secondary Outcome Measures
NameTimeMethod
Fecal microbiome composition6-th day of fasting and 12 weeks after fasting compared to baseline

Measured by 16S Sequencing

Office systolic blood pressure6-th day of fasting and 12 weeks after fasting compared to baseline

Mean of five consecutive blood pressure measurements (mmHg)

Resting Energy Expenditure - Recovery12 weeks after fasting compared to baseline

Measured by indirect calorimetry (kcal/d)

Glucose variabilityFrom 3 days before until 6 days after fasting

Measured by continuous glucose monitoring over 14 days

Office diastolic blood pressure6-th day of fasting and 12 weeks after fasting compared to baseline

Mean of five consecutive blood pressure measurements (mmHg)

Resting Respiratory Exchange Ratio6-th day of fasting and 28 days after fasting compared to baseline

Measured by indirect calorimetry

Fecal and serum metabolome6-th day of fasting and 12 weeks after fasting compared to baseline

Measured by mass spectrometry

Neural correlates of emotion processing6-th day of fasting and 12 weeks after fasting compared to baseline

Measured by functional Magnetic Resonance Imaging

Perceived Stress Questionaire (PSQ)6-th day of fasting and 12 weeks after fasting compared to baseline

Range 0-100, with 0 indicating no perceived stress

International Physical Activity Questionaire (IPAQ, long version)6-th day of fasting and 12 weeks after fasting compared to baseline

Time for moderate and vigorous activity (hours, minutes)

Change in immune cell phenotypes6-th day of fasting and 12 weeks after fasting compared to baseline

Peripheral blood effector T cell frequencies (Percent)

Neural correlates of food-specific delay discounting6-th day of fasting and 12 weeks after fasting compared to baseline

Measured by functional Magnetic Resonance Imaging

Perceived Self Efficiency6-th day of fasting and 12 weeks after fasting compared to baseline

Range 10-40, with 40 indicating highest self efficiency

PANAS Positive Affect Subscale (GESIS Panel)6-th day of fasting and 12 weeks after fasting compared to baseline

Range 10-50, with 50 indicating highest positive affect

PANAS Negative Affect Subscale (GESIS Panel)6-th day of fasting and 12 weeks after fasting compared to baseline

Range 10-50, with 50 indicating highest negative affect

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin

🇩🇪

Berlin, Germany

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