Prolonged Fasting With Meditation and Mild Physical Exercise

The Physical and Mental Effects of Prolonged Fasting With Meditation and Mild Physical Exercise

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.

Study Overview

• Status: Unknown
• Conditions: Fasting
• Intervention / Treatment: Behavioral: prolonged fasting

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 ).	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary ketone	Changes in urinary ketone 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
Vitamin examination	Changes in vitamin including vitamin C,D,E and etc. will be assessed.	Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Thyroid function	Changes in Thyroid function test including FT3，FT4，TSH will be assessed.	Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Inflammatory factors	Changes in inflammatory factors includingIL1, IL2, IL6, IL10，TNF ,TGFβ and etc. will be assessed.	Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Gut microbiome	Stool samples were collected in time if possible and analyzed the composition /function of the intestinal microflora by High-throughput sequencing	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
Self-rating depression scale；	The Scale ,includes half of items ues positive words and half is negatively,which could assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The scale standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).	Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Self-Rating Anxiety Scale；	The Scale contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). There are fifteen questions involved in the assessment could indicate the increase of anxiety levels, and rest of the questions assessment would decrease of the anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The scale standard scores were used to define four categories of anxiety severity: within normal ranger no significant psychopathology (25-49points); presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).	Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Hamilton Anxiety Scale	Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at 1 day、4 day、6 day、9 day、40 day. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at 1 day、4 day、6 day、9 day、40 day.	Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Hamilton Depression Scale	Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.	Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Lijun Jia, Ph.D., Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2018
• Primary Completion (Anticipated): April 9, 2019
• Study Completion (Anticipated): September 9, 2019

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: meditation; physical exercise; prolonged fasting
• Other Study ID Numbers: ShanghaiUTCMjialijun

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No