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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 ). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prolonged fasting | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Lijun Jia, Ph.D. | Shanghai University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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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 |
| 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 |