The Physical and Mental Effects of Prolonged Fasting With Meditation and Mild Physical Exercise
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Weight
Study Overview
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
- Recruiting: 45 healthy people will be included in the clinical trial according to the Inclusion criteria and exclusion criteria.
- 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.
- Re-feeding: Gradually distribute participants with rice flour, porridge and juice in the next 3 days.
- Follow-up :The health checklist is similar with that during fasting on the first month.
- 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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18-65 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.
Exclusion Criteria
- •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)
Arms & Interventions
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 ).
Intervention: prolonged fasting (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Insulin
Time Frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Changes in insulin will be assessed.
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.
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 .
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.
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.
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.
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.
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.
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 Outcomes
- 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)
- Self-rating depression scale；(Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting)
- Self-Rating Anxiety Scale；(Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting)
- Hamilton Anxiety Scale(Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting)
- Hamilton Depression Scale(Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting)