CompletedNot Applicable

Long-term Fasting: Multi-system Adaptations in Humans

Germany62 participantsStarted 2021-09-10

Plain-language 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.

Who can participate

Age range20 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * BMI between 22 - 35 kg/m2 Exclusion Criteria: * intake of medication (cardiovascular diseases, lipid and glucose metabolism) * chronic manifest psychical and psychiatric diseases * participation in another study * pregnancy or breastfeeding * in the MRI/MRS sub-study, any MRI contraindication (claustrophobia, pacemakers, MR-incompatible prosthetic valves, metallic implants, foreign metallic body) * active uncontrolled gastrointestinal disorders including ulcerative colitis, Crohn's disease, indeterminate colitis, severe irritable bowel syndrome, persistent infectious gastroenteritis, persistent or chronic diarrhea of unknown etiology, recurrent Clostridium difficile infection * major surgery of the GI tract, in the past five years. Any major bowel resection at any time * intake of antibiotics in the last 2 months

What they're measuring

Changes in whole body composition

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the heart

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the liver

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the kidney

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the spleen

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the quadriceps

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the adipose tissue

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Trial details

NCT IDNCT05031598

SponsorBuchinger Wilhelmi Development & Holding GmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-30

View on ClinicalTrials.gov More Fasting trials

Who can participate

Age range20 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in whole body composition

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the heart

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the liver

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the kidney

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the spleen

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the quadriceps

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards

Changes in the composition of the adipose tissue

Timeframe: Baseline and changes at the end of fasting as well as one and four months afterwards