Brief Summary

The aim of this trial is to investigate the effects of long-term fasting on size, mass, composition and function of metabolic active tissues in several organs that reexpand possibly rejuvenated after 1-4 months. Additionally, the lipid metabolism is investigated in depth.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Sep 2021

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

August 11, 2021

Completed

22 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed

8 days until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed

Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

August 11, 2021

Last Update Submit

February 7, 2023

Conditions

Fasting

Keywords

long-term fastingBuchinger Wilhelmi programmagnetic resonance imaging (MRI)magnetic resonance spectroscopy (MRS)HDL efflux capacityfatty acid profile in erythrocyte membranegut microbiotametabolomicshydrogen sulfide and transsulfuration pathway

Outcome Measures

Primary Outcomes (13)

Changes in whole body composition
Fat mass, lean mass, water content measured by magnetic resonance imaging
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the heart
Fat mass, lean mass, water content measured by magnetic resonance imaging
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the liver
Fat mass, lean mass, water content measured by magnetic resonance imaging
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the kidney
Fat mass, lean mass, water content measured by magnetic resonance imaging
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the spleen
Fat mass, lean mass, water content measured by magnetic resonance imaging
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the quadriceps
Fat mass, lean mass, water content measured by magnetic resonance imaging
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the adipose tissue
Fat mass, lean mass, water content measured by magnetic resonance imaging
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in HDL cholesterol efflux capacity
measured in serum by a standardized used radioisotopic technique
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in serum cholesterol loading capacity
measured in serum using radioactive cholesterol loaded macrophages
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in HS-Omega-3 Index
Determination of fatty acid (C 14:0; 16:0; 18:0; 20:0; 22:0; 24:0; 16:1 n-7; 18:1 n-9; 20:1 n-9; 24:1 n-9; 18:2 n-6; 18: 3 n-6; 20: 3 n-6; 22:2 n-6; 20:4 n-6; 22:4 n-6; 22:5 n-6; 18: 3 n-3; 20:5 n-3; 22:5 n-3; 22:6 n-3; 16:1 n-7t; 18:1 n-9t; 18:2 n-6tt; 18:2 n-6ct; 18:2 n-6tc) in erythrocyte membranes with highly standardized analytical procedure
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in faecal microbiota composition and function (carbohydrate metabolism)
Shotgun metagenomics, 5Gb of DNA sequencing data.
Baseline and changes after an average of 10 (+/-3) fasting days
Changes in metabolome
using an untargeted metabolomics approach to investigate changes in the metabolome, with a focus on the polyamine biosynthetic pathway at the cellular level in PBMCs and compare them with changes in the circulating plasma/serum metabolome
Baseline and changes after 3 fasting days, the end of fasting as well as one and four months afterwards
Changes in hydrogen sulfide production capacity
measured in serum and urine using the lead acetate assay
Baseline and changes at the end of fasting as well as one and four months afterwards

Secondary Outcomes (39)

Changes in brain morphometry
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in cardiac mass
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in lower limbs (quadriceps, hamstrings, calves)
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in lumbosacral muscle mass
Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in systolic cardiac function
Baseline and changes at the end of fasting as well as one and four months afterwards
+34 more secondary outcomes

Other Outcomes (49)

Changes in body weight
Baseline, daily during fasting and food reintroduction as well as one and four months afterwards
Changes in body mass index
Baseline, daily during fasting and food reintroduction as well as one and four months afterwards
Changes in abdominal circumference
Baseline and changes at the end of fasting as well as one and four months afterwards
+46 more other outcomes

Study Arms (1)