The effects of 10-day complete fasting on human health and metabolism
| ISRCTN | ISRCTN17045897 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17045897 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | SMFA17A02 |
| Sponsor | State Key Laboratory of Space Medicine Fundamentals and Application and the China Astronaut Research and Training Center |
| Funders | State Key Laboratory of Space Medicine Fundamentals and Application, China Astronaut Research and Training Center (SMFA17A02, SMFA18B02, SMFA18B06, SMFA19C01, SMFA19C03), Science, Technology and Innovation Commission of Shenzhen Municipality 2020 Basic Research Project (JCYJ20200109110630285)., Advanced Space Medico-Engineering Research Project of China (18035020103), Space Medical Experiment Project of China Manned Space Program (HYZHXM01002) |
- Submission date
- 17/05/2022
- Registration date
- 24/05/2022
- Last edited
- 10/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Interventional case series |
| Secondary study design | |
| Study type | Participant information sheet |
| Scientific title | The effects of 10-day complete fasting hypometabolism on human health and homeostasis |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
1. Body weight is measured by an electric scale every day throughout the study |
| Key secondary outcome measure(s) |
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) |
| Completion date | 08/06/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 14 |
| Total final enrolment | 13 |
| Key inclusion criteria | 1. Healthy male 2. 25-55 years old 3. BMI 20-32 kg/m² |
| Key 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 |
| Date of first enrolment | 03/05/2018 |
| Date of final enrolment | 10/05/2018 |
Locations
Countries of recruitment
- China
Study participating centre
Longgang District
Shenzhen
518117
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |
| Results article | 26/12/2024 | 10/06/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/06/2025: Publication reference added.
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.
