Healthy
Conditions
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.
Interventions
OTHERBuchinger fasting
Caloric intake of \< 250 kcal/d for 5 days
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Waiting list control group
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resting Energy Expenditure | 6-th day of fasting compared to baseline | Measured by indirect calorimetry (kcal/d) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting Respiratory Exchange Ratio | 6-th day of fasting and 28 days after fasting compared to baseline | Measured by indirect calorimetry |
| Office systolic blood pressure | 6-th day of fasting and 12 weeks after fasting compared to baseline | Mean of five consecutive blood pressure measurements (mmHg) |
| Office diastolic blood pressure | 6-th day of fasting and 12 weeks after fasting compared to baseline | Mean of five consecutive blood pressure measurements (mmHg) |
| Fecal microbiome composition | 6-th day of fasting and 12 weeks after fasting compared to baseline | Measured by 16S Sequencing |
| Fecal and serum metabolome | 6-th day of fasting and 12 weeks after fasting compared to baseline | Measured by mass spectrometry |
| Change in immune cell phenotypes | 6-th day of fasting and 12 weeks after fasting compared to baseline | Peripheral blood effector T cell frequencies (Percent) |
| Glucose variability | From 3 days before until 6 days after fasting | Measured by continuous glucose monitoring over 14 days |
| Resting Energy Expenditure - Recovery | 12 weeks after fasting compared to baseline | Measured by indirect calorimetry (kcal/d) |
| Neural correlates of food-specific delay discounting | 6-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 |
| Perceived Self Efficiency | 6-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 |
| 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) |
| Neural correlates of emotion processing | 6-th day of fasting and 12 weeks after fasting compared to baseline | Measured by functional Magnetic Resonance Imaging |
Countries
Germany
Outcome results
None listed