FastingNCT03754920
Prolonged Fasting With Meditation and Mild Physical Exercise
A study testing prolonged fasting in people with Fasting, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- prolonged fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2018to 9 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200030
About this study
Official title: 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.
Read the 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.
- Conditions
- Fasting
- Being tested
- prolonged fasting
- Keywords
- prolonged fasting, meditation, physical exercise
- Medical subject headings
- Fasting, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolonged fastingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 ). Receives: Behavioral: prolonged fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Changes in weight will be assessed.
Measured: 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.
Measured: 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.
Measured: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Blood pressure
Changes in blood pressure will be assessed.
Measured: 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 .
Measured: 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.
Measured: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Pulse Rate
Changes in pulse rate will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Secondary outcomes (9)
Urinary ketone
Changes in urinary ketone will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start9 Sep 2018
- Primary completion9 Apr 2019 (estimated)
- Study completion9 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lijun Jia, Ph.D., Principal investigator, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754920
- Sponsor's protocol ID
- ShanghaiUTCMjialijun
- Status last verified
- Oct 2018
- First submitted
- 14 Nov 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physical and Mental Effects of Prolonged Fasting With Meditation and Mild Physical Exercise
- ClinicalTrials.gov ID
- NCT03754920
- Acronym / sponsor ID
- ShanghaiUTCMjialijun
- Conditions
- Fasting
- Keywords
- prolonged fasting, meditation, physical exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 9 Apr 2019 (estimated)
- Study completion
- 9 Sep 2019 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prolonged fasting | Experimental | Behavioral: prolonged fastingParticipants fast for five days, without any food, except unlimited mineral water, and do some fitness regimen(such as meditation and mild physical exercise ). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prolonged fastingFasting 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. | Behavioural | prolonged fasting |
Primary outcome
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.
9 secondary outcomes
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
Vitamin examination
Time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Thyroid function
Time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Inflammatory factors
Time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
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
Self-rating depression scale；
Time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Self-Rating Anxiety Scale；
Time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Hamilton Anxiety Scale
Time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Hamilton Depression Scale
Time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Fasting
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
RecruitingPhase 2
Targeting HealthY Eating to Maintain Energy While Living With Cancer
Fatigue in Cancer Survivors
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijun Jia, Ph.D. principal investigator
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prolonged fasting in people with Fasting, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.