Prolonged Fasting With Meditation and Mild Physical Exercise

NCT03754920 | Unknown

• 1 other identifier: ShanghaiUTCMjialijun
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasting

Keywords

prolonged fasting; meditation; physical exercise

Outcome Measures

Primary Outcomes (11)

• Weight

  Changes in weight will be assessed.

  Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting

• Blood glucose

  Changes in blood glucose will be assessed.

  Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting

• Insulin

  Changes in insulin will be assessed.

  Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

• Blood pressure

  Changes in blood pressure will be assessed.

  Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting

• Waistline

  Changes in waistline will be assessed .

  Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting

• IGF-1

  Changes in IGF-1 will be assessed.

  Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

• Pulse Rate

  Changes in pulse rate will be assessed.

  Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting

• Blood lipid test

  Changes in blood including HDL, LDL, TG, CHO and ect. will be assessed.

  Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

• Urine test

  Changes in urine including uric acid and ect. will be assessed.

  Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

• Liver and renal function test

  Changes in liver and renal function including AST,ALT,ALP, TP,ALB, Urea, Crea and ect will be assessed at 7：30 am.

  Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

• Serum metabolomics analysis

  Serum samples were collected and serum metabolomics (carbohydrate, lipid, amino acid and ect.) were sequenced and analyzed by High-throughput sequencing.

  Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

Secondary Outcomes (9)

• Urinary ketone

  Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting

• Vitamin examination

  Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

• Thyroid function

  Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

• Inflammatory factors

  Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

• Gut microbiome

  Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting

Study Arms (1)

prolonged fasting

EXPERIMENTAL

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

Behavioral: prolonged fasting

Interventions

prolonged fasting 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.

prolonged fasting

Eligibility Criteria

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

You may qualify if:

• years old, no nationality limitation, no gender limitation;
• Male weight ≥ 50 kg, female weight ≥ 45 kg；BMI: 19-28 kg/m²;
• The index of physical examination is in line with health standards;
• People who have gone through a 7-day fasting before ;
• Agree to take part in the trials and sign the informed consent form.

You may not qualify if:

• 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)) ;
• People who processed fasting within one month;
• Pregnancy, current breast-feeding or menstrual period;
• People who are marantic, malnourished or anorectic;
• People who have cardiovascular disease(coronary heart disease, atherosclerosis, arrhythmia, etc), serious metabolic and psychiatric disorders(hypertension, type 2 diabetes, hyperthyroidism, etc.);
• People who have Mental illness, cancer, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), syphilis, human immunodeficiency virus (HIV) antibody positive.
• people who has mental disorders according to the scales(Hamilton Anxiety Scale、Self-Rating Anxiety Scale、Self-rating depression scale)

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Fasting; Motor Activity

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Lijun Jia, Ph.D.

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 27, 2018
• Study Start: September 9, 2018
• Primary Completion: April 9, 2019
• Study Completion: September 9, 2019
• Last Updated: December 4, 2018

Record last verified: 2018-10

Locations

CN (1)