Prolonged Fasting With Meditation and Mild Physical Exercise

NCT ID: NCT03754920

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-09
• Study Completion Date: 2019-09-09

Brief Summary

To determine the feasibility, safety and efficacy of fasting, participants are recruited in a 5-days fasting ( without any food, except unlimited mineral water),and do some fitness regimen (such as meditation and mild physical exercise ) during fasting.The samples will be collected from participates and subjected to comprehensive analysis ,including routine medical examination in blood, metabonomics and proteomics anlysis in serum and urine samples, gut microbiome analysis in stood samples, and so on.

Detailed Description

1. Recruiting: 45 healthy people will be included in the clinical trial according to the Inclusion criteria and exclusion criteria.

2. Fasting : Participants fast for five days, without any food, except unlimited mineral water. Participants will do some fitness regimen (such as meditation and mild physical exercise ) during fasting.

3. Re-feeding: Gradually distribute participants with rice flour, porridge and juice in the next 3 days.

4. Follow-up :The health checklist is similar with that during fasting on the first month.

5. Data processing, statistics and analysis. Diet monitoring: The intake of glucose decreases, while the burning of fat increases, which can down-regulate glucose level in blood, up-regulate ketone level in urine. Thus, the fasting situation of participants can be monitored by the variation of blood glucose and urine ketone.

Conditions

Fasting

Study Design

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

Study Groups

prolonged fasting

Participants fast for five days, without any food, except unlimited mineral water, and do some fitness regimen(such as meditation and mild physical exercise ).

Group Type: EXPERIMENTAL

prolonged fasting

Intervention Type: BEHAVIORAL

Fasting for 5 days: Fasting with some fitness regimen, such as meditation and mild physical exercise;

Feeding for 3 days: Gradually distribute participants with rice flour, porridge and juice.

Interventions

prolonged fasting

Fasting for 5 days: Fasting with some fitness regimen, such as meditation and mild physical exercise;

Feeding for 3 days: Gradually distribute participants with rice flour, porridge and juice.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 18-65 years old, no nationality limitation, no gender limitation;

2. Male weight ≥ 50 kg, female weight ≥ 45 kg；BMI: 19-28 kg/m²;

3. The index of physical examination is in line with health standards;

4. People who have gone through a 7-day fasting before ;

5. Agree to take part in the trials and sign the informed consent form.

Exclusion Criteria

1. People with unhealthy habits, such as smoking(5 cigarettes per day, or can not stop smoking in the trial), excessive drinking(drink regularly in the recent 6 months or more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml alcohol with 40% spirits or 150 ml wine)) ;

2. People who processed fasting within one month;

3. Pregnancy, current breast-feeding or menstrual period;

4. People who are marantic, malnourished or anorectic;

5. People who have cardiovascular disease(coronary heart disease, atherosclerosis, arrhythmia, etc), serious metabolic and psychiatric disorders(hypertension, type 2 diabetes, hyperthyroidism, etc.);

6. People who have Mental illness, cancer, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), syphilis, human immunodeficiency virus (HIV) antibody positive.

7. people who has mental disorders according to the scales(Hamilton Anxiety Scale、Self-Rating Anxiety Scale、Self-rating depression scale)

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

Sponsors

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lijun Jia, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai University of Traditional Chinese Medicine

Locations

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ShanghaiUTCMjialijun

Identifier Type: -

Identifier Source: org_study_id