Fasting Effects on Metabolism and Immunity Study in Human

NCT ID: NCT06779201

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-12-31

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.

Detailed Description

As a historic practice, fasting has a place in religion, culture and modern medicine. In recent years, studies have found that moderate food interruption can positively affect metabolism, immunity, and brain function. It can promote cellular autophagy, improve insulin sensitivity, reduce inflammation, and may protect brain health. Intermittent fasting is thought to improve metabolic health, reduce the risk of obesity and type 2 diabetes, and promote cellular self-repair by regulating signaling pathways. Food fasting also improves insulin sensitivity, reduces blood glucose, reduces inflammatory markers, and improves fat oxidation rate, contributing in the prevention and treatment of metabolic diseases. Moreover, food fasting can regulate immune cell function, reduce chronic inflammation, and may regulate immune function by affecting gut microbiota diversity. In terms of brain function, fasting may improve cognitive function by promoting neuroplasticity and enhancing neuroprotective mechanisms. However, most of the existing studies focus on animal experiments, lack large-scale human clinical trials, and the mechanism of feeding is not completely clear. This study will explore the effects of complete fasting for 1 week (but can feel free to drink water) on human immune function, metabolic indicators and brain function in human, and analyze its change mechanism from a multi-omics perspective and/or other ways, so as to provide new data support for understanding the biological mechanism of fasting, and promote its application in disease prevention and treatment.

Conditions

Fasting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Adults who can tolerate a certain degree of hunger

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

Group Type: EXPERIMENTAL

Fasting

Intervention Type: OTHER

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

Interventions

Fasting

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18-65 years old, gender is not limited;

2. BMI≥18.5;

3. Can tolerate a certain degree of hunger;

4. Can voluntarily sign written informed consent.

Exclusion Criteria

1. Women planning pregnancy, pregnancy and breastfeeding;

2. Previous liver disease, chronic kidney disease, heart disease and cerebrovascular disease;

3. Suffering from acute infectious diseases or chronic wasting diseases;

4. Have used antibiotic drugs in the past 3 months, and have used prebiotic or probiotic supplements or products in the past month;

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongxing Wang, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Rui Li, MD

Role: CONTACT

ruili@mail.ccmu.edu.cn

+86 10 83198650

Huang Wang, MD

Role: CONTACT

wanghuang118@mail.ccmu.edu.cn

+86 10 83198650

Facility Contacts

Hongxing Wang, MD & PhD

Role: primary

hxwang8888@126.com

01083198650

Other Identifiers

fasting

Identifier Type: -

Identifier Source: org_study_id