Does a 12-hour fast influence weight loss and cardiovascular risk in people with obesity?
| ISRCTN | ISRCTN29704208 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29704208 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PCT1E-20 |
| Sponsor | University of Valencia |
| Funder | Universitat de València |
- Submission date
- 09/12/2020
- Registration date
- 15/12/2020
- Last edited
- 15/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Currently, one of the most commonly employed strategies for reducing body weight in overweight or obese individuals is to reduce the number of calories in the diet and to increase physical activity. However, the desired success is not always achieved or secondary effects arise in the state of health. Another of the strategies put forward for achieving weight loss without focusing on reducing the calories in a diet is to act on the meal times. According to this strtategy, having earlier lunches or dinners is associated with greater weight loss and an reduced risk of suffering heart disease. These results have given rise to a boom in 'chrononutritional' research (looking at meal times). The main aim of this study is to get to know the effect that fasting for 12 hours has on weight loss, body composition, and heart disease risk in overweight or obese elderly population in comparison with a control group without any intervention.
Who can participate?
Healthy men and women from the general population (aged 18-65 years)
What does the study involve?
We will carry out a randomised parallel trial in healthy volunteers.
The intervention will consist of implementing, over six months, a 12-hour fasting period between the last evening-night food intake and the next intake during the morning of the following day. The intervention group will be able to choose the time they eat and without restriction, depending on each participant’s preference. This will be backed up by dietary and chronobiological advice in individual sessions, where recommendations on how to undertake and to maintain that fasting period over time will be provided. The control group will not undertake any fasting period and will continue to follow their normal dietary pattern. The participants in the intervention group will also maintain their customary diet so that both groups have a diet without any set calorie restrictions. The participants of both groups will be asked to continue with their habitual physical activity.
What are the possible benefits and risks of participating?
Participants will be informed that there are not benefits and risks expected.
Where is the study run from?
University of Valencia (Spain)
When is the study starting and how long is it expected to run for?
October 2020 to December 2022
Who is funding the study?
University of Valencia (Spain)
Who is the main contact?
Prof. José V. Sorlí, sorli@uv.es
Contact information
Scientific
Avda. Blasco Ibanez 15
Valencia
46010
Spain
 ORCID ID |
0000-0002-0130-2006 |
|---|---|
| Phone | +34 (0)963864417 |
| sorli@uv.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized parallel trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Chronobiological influence of fasting time on weight loss and cardiovascular risk profile in an overweight or obese adult population: A randomized controlled trial |
| Study acronym | FASTING-12 |
| Study objectives | A 12-hour per day fasting period over 6 months compared to a restriction-free diet can modify weight loss and cardiovascular risk profile, as well as have an influence on the metabolome. |
| Ethics approval(s) | Approved 04/12/2020, Institutional review board of Valencia University (Avda. Blasco Ibanez 13. Valencia, 46010, Spain; +34 963864109; vicerec.investigacio@uv.es), ref: UV-INV_ETICA-1501553 |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | The intervention will consist of implementing, over six months, a 12-hour fasting period between the last evening-night food intake and the next intake during the morning of the following day. Participants will be randomly assigned 1:1 to the order of the intervention by simple random assignment through a computer program. The intervention group will be able to choose the time they eat and without restriction, depending on each participant’s preference. This will be backed up by dietary and chronobiological advice in individual sessions, where recommendations on how to undertake and to maintain that fasting period over time will be provided. The control group will not undertake any fasting period and will continue to follow their normal dietary pattern. The participants in the intervention group will also maintain their customary diet so that both groups have an “at libitum” diet without any a priori calorie restrictions. The participants of both groups will be asked to continue with their habitual physical activity. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Measured at baseline and during intervention (the first month, the third month and the sixth month): |
| Key secondary outcome measure(s) |
At baseline and after the intervention: |
| Completion date | 16/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Volunteers recruited from the general population 2. Between 18 and 65 years old 3. BMI between 25 and 40 kg/m² |
| Key exclusion criteria | 1. Individuals who have previously undergone diets that include fasting for a period of greater than 12 hours over the last year or who have undertaken a restricted calorie intervention over the last six months, and those who have skipped normal meal times as a dietary practice. 2. Pregnant or breast-feeding women 3. Individuals with infectious diseases. 4. Liver cirrhosis or chronic renal failure 5. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc 6. Cancer 7. Alcohol abuse or addition 8. Current treatment with systemic corticosteroids 9. Current use of weight loss medication 10. Any other condition that may interfere with the completion of the study protocol |
| Date of first enrolment | 17/12/2020 |
| Date of final enrolment | 01/04/2022 |
Locations
Countries of recruitment
- Spain
Study participating centres
Department of Preventive Medicine
Avda. Blasco Ibanez 15
Valencia
46010
Spain
Calle Sinesio Delgado 10
Madrid
28029
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Data will not be available outside the core research group as the informed consent form signed by participants stated that individual-level data will not be publicly available. Researchers who are interested in this study can contact the main investigator (Dr JV Sorlí) if they have any questions regarding the data or are interested in further collaborations. The participants will receive written information about what the study involves and sign a consent form before entering the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/12/2020: Trial’s existence confirmed by Valencia University.
