Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06779201

Study on the Effect and Mechanism of Fasting on Human Metabolism and Immunity

Led by Xuanwu Hospital, Beijing · Updated on 2025-01-22

30

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effects of a 1-week complete fast, allowing water intake, on human immune function, metabolism, and brain function. This study focuses on exploring the biological mechanisms behind these changes using a multi-omics approach, aiming to provide new insights into fasting's role in disease prevention and treatment. Current evidence mainly comes from animal studies, so this research seeks to fill gaps in human clinical data. Participants will undergo a full fast for seven days during which they may drink water freely. The study includes multiple follow-up periods: baseline before fasting, end of fasting at day 8, one week re-feeding at day 15, four weeks re-feeding at day 36, and twelve weeks re-feeding at day 92. Throughout these times, various biological samples and assessments will be collected and analyzed. During the study, participants will provide blood, urine, and stool samples at specified time points to measure cytokines, metabolites, intestinal flora, blood lipids, insulin, thyroid function, and body fat percentage. Brain function will also be evaluated. These repeated measures allow researchers to track changes from before fasting through different re-feeding stages. The total participation spans about three months, including monitoring and safety evaluations throughout the study period.

CONDITIONS

Brief Title

Fasting Effects on Metabolism and Immunity Study in Human

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years old, any gender
  • Body mass index (BMI) of 18.5 or higher
  • Ability to tolerate a certain degree of hunger
  • Willingness and ability to sign written informed consent
Not Eligible

You will not qualify if you...

  • Women who are pregnant, planning pregnancy, or breastfeeding
  • History of liver disease, chronic kidney disease, heart disease, or cerebrovascular disease
  • Presence of acute infectious diseases or chronic wasting diseases
  • Use of antibiotic drugs within the past 3 months or prebiotic/probiotic supplements within the past month
  • Participation in other clinical trials within 3 months before enrollment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 week

Participants undergo a complete fast for one week, during which they may drink water freely. This fasting period aims to study its effects on metabolism, immunity, and brain function.

Visits at baseline (Day 0) and end of fasting (Day 8)

Post-treatment Follow-up

Duration - 12 weeks

Participants are monitored during a re-feeding phase for up to twelve weeks to observe changes in metabolic, immune, and brain function after fasting.

Follow-up visits on Day 15, Day 36, and Day 92

Trial Site Locations

Total: 1 location

1

Xuanwu Hospital, Capital Medical University

Beijing, China, 100053

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Research Team

R

Rui Li, MD

H

Huang Wang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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