Fasting Effects on Metabolism and Immunity Study in Human

NCT06779201 | Recruiting DMC

• 1 other identifier: fasting
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fasting

Keywords

Fasting; Metabolism; Immunity; Brain function; Intestinal flora

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 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.

  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 (7)

• 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.

  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.

• The change of brain function from T1 to T2, T3, T4, and T5.

  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.

• The change of blood lipid levels from T1 to T2, T3, T4, and T5.

  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.

• The change of homocysteine levels from T1 to T2, T3, T4, and T5

  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.

• The change of insulin levels in subjects' blood samples from T1 to T2, T3, T4, and T5.

  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.

Study Arms (1)

Adults who can tolerate a certain degree of hunger

EXPERIMENTAL

The subjects will undergo a complete fast for one week (water is allowed).

Other: Fasting

Interventions

Fasting OTHER

One-week fasting without limit of water drink (Participants can feel free to drink water )

Adults who can tolerate a certain degree of hunger

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Participate in other clinical investigators within 3 months before enrollment in this study.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Hongxing Wang, MD & PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Li, MD

CONTACT

+86 10 83198650; ruili@mail.ccmu.edu.cn

Huang Wang, MD

CONTACT

+86 10 83198650; wanghuang118@mail.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 16, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)