Prolonged Fasting With Meditation and Mild Physical Exercise

• ClinicalTrials.gov Identifier: NCT03754920
• Recruitment Status: Unknown
• First Posted: November 27, 2018
• Last Update Posted: December 4, 2018
• Sponsor: Shanghai University of Traditional Chinese Medicine
• Information provided by (Responsible Party): Shanghai University of Traditional Chinese Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fasting	Behavioral: prolonged fasting	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Physical and Mental Effects of Prolonged Fasting With Meditation and Mild Physical Exercise
• Actual Study Start Date: September 9, 2018
• Estimated Primary Completion Date: April 9, 2019
• Estimated Study Completion Date: September 9, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Weight [ Time Frame: 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 ]
   Changes in weight will be assessed.
2. Blood glucose [ Time Frame: 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 ]
   Changes in blood glucose will be assessed.
3. Insulin [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   Changes in insulin will be assessed.
4. Blood pressure [ Time Frame: 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 ]
   Changes in blood pressure will be assessed.
5. Waistline [ Time Frame: 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 ]
   Changes in waistline will be assessed .
6. IGF-1 [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   Changes in IGF-1 will be assessed.
7. Pulse Rate [ Time Frame: 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 ]
   Changes in pulse rate will be assessed.
8. Blood lipid test [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   Changes in blood including HDL, LDL, TG, CHO and ect. will be assessed.
9. Urine test [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   Changes in urine including uric acid and ect. will be assessed.
10. Liver and renal function test [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
    Changes in liver and renal function including AST,ALT,ALP, TP,ALB, Urea, Crea and ect will be assessed at 7：30 am.
11. Serum metabolomics analysis [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
    Serum samples were collected and serum metabolomics (carbohydrate, lipid, amino acid and ect.) were sequenced and analyzed by High-throughput sequencing.

Secondary Outcome Measures :

1. Urinary ketone [ Time Frame: 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 ]
   Changes in urinary ketone will be assessed.
2. Vitamin examination [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   Changes in vitamin including vitamin C,D,E and etc. will be assessed.
3. Thyroid function [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   Changes in Thyroid function test including FT3，FT4，TSH will be assessed.
4. Inflammatory factors [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   Changes in inflammatory factors includingIL1, IL2, IL6, IL10，TNF ,TGFβ and etc. will be assessed.
5. Gut microbiome [ Time Frame: 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 ]
   Stool samples were collected in time if possible and analyzed the composition /function of the intestinal microflora by High-throughput sequencing
6. Self-rating depression scale； [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   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).
7. Self-Rating Anxiety Scale； [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   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).
8. Hamilton Anxiety Scale [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   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.
9. Hamilton Depression Scale [ Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

China, Shanghai

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai, China, 200030

Sponsors and Collaborators

Shanghai University of Traditional Chinese Medicine

Investigators

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

More Information

• Responsible Party: Shanghai University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT03754920
• Other Study ID Numbers: ShanghaiUTCMjialijun
• First Posted: November 27, 2018
• Last Update Posted: December 4, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai University of Traditional Chinese Medicine:

prolonged fasting; meditation; physical exercise