Clinical trial NCT03754920: Prolonged Fasting With Meditation and Mild Physical Exercise
Official title: The Physical and Mental Effects of Prolonged Fasting With Meditation and Mild Physical Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasting
Keywords: prolonged fasting
meditation
physical exercise
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Weight
timeFrame: 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
measure: Blood glucose
timeFrame: 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
measure: Insulin
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Blood pressure
timeFrame: 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
measure: Waistline
timeFrame: 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
measure: IGF-1
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Pulse Rate
timeFrame: 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
measure: Blood lipid test
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Urine test
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Liver and renal function test
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Serum metabolomics analysis
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Secondary outcomes:
measure: Urinary ketone
timeFrame: 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
measure: Vitamin examination
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Thyroid function
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Inflammatory factors
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Gut microbiome
timeFrame: 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
measure: Self-rating depression scale；
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Self-Rating Anxiety Scale；
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Hamilton Anxiety Scale
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
measure: Hamilton Depression Scale
timeFrame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Lijun Jia, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: