Fasting Effects on Metabolism and Immunity Study in Human
ConditionFasting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing
About this trial
This study aims to investigate the effects of 1-week fasting but not prohibiting water drink on human immune function, metabolic indicators, and brain function in human, and to explore the underlying mechanisms of these changes from a multi-omics perspective and/or other ways.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-65 years old, gender is not limited;
BMI≥18.5;
Can tolerate a certain degree of hunger;
Can voluntarily sign written informed consent.
Disqualifiers
Women planning pregnancy, pregnancy and breastfeeding;
Previous liver disease, chronic kidney disease, heart disease and cerebrovascular disease;
Suffering from acute infectious diseases or chronic wasting diseases;
Have used antibiotic drugs in the past 3 months, and have used prebiotic or probiotic supplements or products in the past month;
Trial design
Design model
Single group
Treatments tested in this trial
Fasting
Other interventionOne-week fasting without limit of water drink (Participants can feel free to drink water )
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Adults who can tolerate a certain degree of hungerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The change of cytokine levels in subjects' blood (and/or urine/stool) samples from T1 to T2, T3, T4, and T5.
Cytokines measured included pro-inflammatory cytokines such as IL-1β, IL-6, and TNF-α, as well as anti-inflammatory cytokines such as IL-10 and TGF-β.
Time frame
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.2
The change of metabolite levels in subjects' blood (and/or urine/stool) samples from T1 to T2, T3, T4, and T5.
Metabolites measured include metabolic levels of amino acids, short-chain fatty acids, steroid hormones, fat-soluble vitamins, and other substances.
Time frame
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.Secondary outcomes
1
The change in concentration of intestinal flora species，rate of change in bacterial diversity，abundance of functional genes in subjects' stool samples from T1 to T2, T3, T4, and T5.
Measure the concentration of specific bacterial species, e.g., relative and absolute abundance of Thick-walled phylum, Mycobacterium phylum, etc.; assess the rate of change in the diversity of the bacterial community, including α-diversity and β-diversity.
Time frame
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.2
The change of brain function from T1 to T2, T3, T4, and T5.
The effects of fasting on brain function were assessed by resting-state functional magnetic resonance imaging (rs-fMRI) and diffusion tensor imaging (DTI) for local coherence (ReHo) and low-frequency amplitude (ALFF), which were used to assess changes in functional brain activity. Fraction of anisotropy (FA), axial dispersion (AD), radial dispersion (RD), and mean dispersion (MD), were used to assess the structural integrity of cerebral white matter.
Time frame
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.3
The change of blood lipid levels from T1 to T2, T3, T4, and T5.
Lipids measured include total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, Apolipoprotein A, and Apolipoprotein B.
Time frame
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.4
The change of homocysteine levels from T1 to T2, T3, T4, and T5
Time frame
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.Sponsors and contacts
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Source ClinicalTrials.gov