Physiological Response to 5 Days Fasting

NCT ID: NCT04452916

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2024-07-01

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Waiting list control group
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fasting

Starts immediately with 5 days of Buchinger fasting

Group Type ACTIVE_COMPARATOR

Buchinger fasting

Intervention Type OTHER

Caloric intake of \< 250 kcal/d for 5 days

Waiting list control

Starts with 5 days of Buchinger fasting after a waiting period of 12 weeks

Group Type PLACEBO_COMPARATOR

Buchinger fasting

Intervention Type OTHER

Caloric intake of \< 250 kcal/d for 5 days

Interventions

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Buchinger fasting

Caloric intake of \< 250 kcal/d for 5 days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Sylvia Bähring, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sylvia Bähring, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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LEANER

Identifier Type: -

Identifier Source: org_study_id

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