The effects of 10-day complete fasting on human health and metabolism
| ISRCTN | ISRCTN17045897 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17045897 |
| Secondary identifying numbers | SMFA17A02 |
- Submission date
- 17/05/2022
- Registration date
- 24/05/2022
- Last edited
- 06/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Fasting is beneficial to many aspects of human health and shows great potential for the treatment of chronic metabolic diseases. The aim of this study is to investigate the safety and the effects on metabolism and health of prolonged water-only fasting. The study's findings should provide evidence to design a new fasting therapeutic strategy for clinical practice.
Who can participate?
Healthy men aged 25 to 55 years with body mass index (BMI) from 19 to 32 kg/m²
What does the study involve?
Participants are recruited and must pass a health examination. The whole experiment lasted 22 days including a 3-day baseline (BL), 10-day complete fasting (CF), 4-day calorie restriction diet (CR) and 5-day full recovery diet (FR) in a controlled building. During the CF period, participants are only permitted to drink water when they want and perform normal activities in the lab building. In the CR phase, the participants are given gradually increased amounts of food to protect their digestive system after CF. During the FR phase, the participants are allowed to return to their normal eating habits. Bodyweight, resting blood pressure and pulse, blood glucose and ketones (β-hydroxybutyrate) are monitored every day in CF and CR. Blood, urine and feces will be collected for routine tests and to measure metabolism, hormones and cytokines at six timepoints including one time before CF, three times during CF, one time during CR and one time in FR. Questionnaires about psychological mood are taken at the same times. Resting metabolic rate will be measured at five timepoints (before, twp times during and two times after).
What are the possible benefits and risks of participating?
There is no economic benefit, but fasting may help to improve health, and the results will help to design new fasting modes even for spaceflight. The main risk is low blood glucose, which will be monitored every day and at any time needed. The whole study will be conducted under medical supervision.
Where is the study run from?
Space Science and Technology Institute (China)
When is the study starting and how long is it expected to run for?
January 2018 to June 2018
Who is funding the study?
1. State Key Laboratory of Space Medicine Fundamentals and Application and the China Astronaut Research and Training Center (China)
2. Advanced Space Medico-Engineering Research Project of China (China)
3. Space Medical Experiment Project of China Manned Space Program (China)
Who is the main contact?
Zhongquan Dai
daizhq77@163.com
Contact information
Principal Investigator
No.26, Beiqing Road
Haidian District
Beijing
100094
China
 ORCID ID |
0000-0002-6152-6407 |
|---|---|
| Phone | +86 (0)13683338750 |
| daizhq77@163.com |
Study information
| Study design | Interventional case series |
|---|---|
| Primary study design | Interventional |
| Secondary study design | |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effects of 10-day complete fasting hypometabolism on human health and homeostasis |
| Study hypothesis | Based on Chinese traditional health methods, in this human experiment fasting was used to change metabolism in order to explain the change pattern and switch time window of energy substrate utilization (glucose-fat-protein), the metabolic change of tissue organ functions such as liver, fat, and intestinal microecology, and the alteration of regulating hormones to appetite, blood sugar, lipid metabolism and others, and to explore the feasibility of using fasting to induce and maintain a hypometabolic state during spaceflight. |
| Ethics approval(s) | Approved 02/05/2018, Biomedical Research Ethics Committee Involving People of the Space Science and Technology Institute (4 Shamiao Road, Longgang District, Shenzhen, Guangdong, China; +86 (0)13688832866; 312506571@qq.com), ref: not applicable |
| Condition | Effects of complete fasting on human health and metabolism |
| Intervention | 10-day water-only fasting in a controlled building including 3-day baseline (BL), 10-day complete fasting (CF), 4-day calorie restriction (CR) and 5-day full recovery (FR). Health status is assessed by monitoring pulse, blood pressure, body weight (BW), blood glucose and ketone, nutritional indices, body composition and biochemistry indexes at different times. Blood, urine and feces are collected to further analyze hormones, cytokines, and intestinal microecology. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Body weight is measured by an electric scale every day throughout the study 2. Blood pressure is measured by an electronic blood pressure monitor every day throughout the study 3. Blood glucose and ketone determined by test strip every day or by a biochemistry method at six timepoints (3 days before fasting, the 3rd day, 6th day and 9th day during fasting, 3 days and 8 days after resuming diet) in hospital 4. Urine acid is measured by biochemistry method in hospital at six timepoints (3 days before fasting, the 3rd day, 6th day and 9th day during fasting, 3 days and 8 days after resuming diet) 5. Body compostion measured by dual-energy X-ray absorptiometry (DEXA) or sfb7 at three timepoints (3 days before fasting, 6th day during fasting 10 days after resuming diet) 6. Blood routine examination in hospital at six timepoints (3 days before fasting, the 3rd day, 6th day and 9th day during fasting, 3 days and 8 days after resuming diet) 7. Psychological mood is measured using the Profle of Mood State (POMS), Visual Analogue Scales (VAS), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Work Ability Index (WAI), Stanford Sleepiness Scale (SSS) at six timepoints (3 days before fasting, the 3rd day, 6th day and 9th day during fasting, 3 days and 8 days after resuming diet |
| Secondary outcome measures | 1. Hormones and cytokines measured by ELISA or biochemistry at six timepoints (3 days before fasting, the 3rd day, 6th day and 9th day during fasting, 3 days and 8 days after resuming diet) 2. Resting metabolic rate is measured by indirect calorimetry at five timepoints (2 days before fasting, 3rd and 9th day during fasting, 3 days and 7-8 days after resuming diet) |
| Overall study start date | 01/01/2018 |
| Overall study end date | 08/06/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 14 |
| Total final enrolment | 13 |
| Participant inclusion criteria | 1. Healthy male 2. 25-55 years old 3. BMI 20-32 kg/m² |
| Participant exclusion criteria | 1. Malignant tumor 2. Serious cardiovascular diseases (congenital heart disease, myocardial infarction, coronary heart disease, angina pectoris, etc) 3. Infectious disease 4. Mental disorders 5. Anemia 6. Hypotension 7. Diabetes mellitus 8. History of gastrointestinal ulcer 9. Other after medical examination |
| Recruitment start date | 03/05/2018 |
| Recruitment end date | 10/05/2018 |
Locations
Countries of recruitment
- China
Study participating centre
Longgang District
Shenzhen
518117
China
Sponsor information
Research organisation
No.26, Beiqing Road, Haidian District
Beijing
100094
China
| Phone | +86 (0)13501332556 |
|---|---|
| skl_acc@126.com |
Funders
Funder type
Research organisation
Government organisation / National government
- Location
- China
Government organisation / Local government
- Alternative name(s)
- Shenzhen Science and Technology Innovation Commission, Shenzhen Science and Technology Innovation Committee, 深圳市科技创新委员会
- Location
- China
No information available
No information available
Results and Publications
| Intention to publish date | 23/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers plan to publish in an international peer-reviewed journal. |
| IPD sharing plan | Data requests should be sent to Zhongquan Dai (daizhq77@163.com). The researchers will provide all the data after they have been published in a journal. Any researcher interested in prolonged fasting can request the data, but not the private data of volunteers by email, if they demonstrate their previous research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/01/2021 | 19/05/2022 | Yes | No | |
| Results article | 19/05/2021 | 19/05/2022 | Yes | No | |
| Results article | 18/09/2022 | 06/10/2022 | Yes | No |
Editorial Notes
06/10/2022: Publication reference added.
19/05/2022: Trial's existence confirmed by the Biomedical Research Ethics Committee Involving People of the Space Science and Technology Institute.
