Does a 24-h fasting period change gene expression and methylation in comparison with a frequent meal pattern?
| ISRCTN | ISRCTN13161183 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13161183 |
| Secondary identifying numbers | PCT1E-19 |
- Submission date
- 11/12/2019
- Registration date
- 13/12/2019
- Last edited
- 14/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Diet is one of the main factors related to gene expression and methylation. There are some genes for which a high level of expression or methylation is protective against ageing or cardiometabolic disease. For other genes increased gene expression is detrimental. Energy restriction or even fasting has been related to protection against ageing and some metabolic diseases. This protection may be mediated by a better autophagy function in animal models. However, the results in humans are scarce. Therefore, the aim of this study is to analyze the influence of a 24-hour fast compared to a pattern of frequent meals in the expression and methylation of selected genes related to autophagy and biological age in adults from a healthy general population.
Who can participate?
Healthy men and women from the general population (aged 25-50 years)
What does the study involve?
Two interventions are compared in a crossover design (each participant receives both interventions in a random order): a) fasting for 24 hours and b) a pattern of frequent meals (consisting of eating 6 times a day with a 3-hour period between each intake). The intake consists of a Mediterranean diet pattern composed of complex carbohydrates, mainly brown rice, vegetables, white meat in the form of chicken, and fruit. The intervention and follow-up are 2 days each, with a "wash-out" period of 2 weeks between interventions.
What are the possible benefits and risks of participating?
Participants will be informed that there are no 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 2019 to December 2023
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
| Study design | Interventional randomised cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Effect of 24-hour fasting versus frequent meals on selected gene expression and methylation: a cross-over randomized and controlled trial |
| Study acronym | FASTING-24 |
| Study objectives | The hypothesis is that short-term fasting, in comparison with a frequent meal pattern, can modify the expression level and/or the methylation of some genes, mainly, those related to autophagy. |
| Ethics approval(s) | Approved 05/12/2019, Institutional review board of Valencia University (human subjects) (Avda. Blasco Ibanez 13, Valencia, 46010, Spain; +34 (0)963864109; vicerec.investigacio@uv.es), ref: UV-INV_ETICA-1205601 |
| Health condition(s) or problem(s) studied | Effect of fasting and a regular meal pattern on gene expression |
| Intervention | This is a short term cross-over randomized trial including 10 participants. Participants will be randomly assigned 1:1 to the order of the two interventions by simple random assignment through a computer program: 1. Fasting for 24 hours 2. Pattern of frequent meals (consisting of eating 6 times a day having a 3 hour period between each intake). The intake will consist of a Mediterranean Diet pattern composed of complex carbohydrates, mainly brown rice, vegetables, white meat in the form of chicken, and fruit. The intervention and follow-up will be 2 days for each treatment in a crossover design. A "wash-out" period of 2 weeks between treatments will be undertaken. |
| Intervention type | Other |
| Primary outcome measure | Methylation and expression of genes related to autophagy measured using DNA and RNA isolated from blood at baseline and after each intervention (at 4 hours) |
| Secondary outcome measures | 1. Fasting glucose and fasting triglycerides measured in fasting plasma by standard procedures from baseline to 4 hours 2. Blood pressure measured from baseline to 4 hours post intervention 3. Weight, height, waist circumference and body composition by bioimpedance measured at baseline 4. Food intake and adherence to the Mediterranean diet measured using the 14-item Mediterranean diet adherence PREDIMED scale at baseline 5. Physical activity measured using the short form of the Minnesota physical activity questionnaire at baseline 6. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire at baseline 7. Chronotype measured using the Horne and Östberg questionnaire at baseline |
| Overall study start date | 14/10/2019 |
| Completion date | 17/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | 1. Volunteers recruited from the general population 2. Between 25 and 50 years old 2. BMI between 23 and 33 kg/m2 |
| Key exclusion criteria | 1. Diseased 2. Diabetics 3. Immunodeficiency or HIV-positive status 4. Liver cirrhosis or chronic renal failure 5. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc 6. Any severe co-morbid condition 7. Alcohol abuse or addiction 8. History of major organ transplantation 9. Concurrent therapy with immunosuppressive drugs or cytotoxic agents 10. Current treatment with systemic corticosteroids 11. Current use of weight loss medication 12. Patients with an acute infection or inflammation 13. Any other condition that may interfere with the completion of the study protocol |
| Date of first enrolment | 20/12/2019 |
| Date of final enrolment | 15/06/2023 |
Locations
Countries of recruitment
- Spain
Study participating centres
Avda. Blasco Ibanez 15
Valencia
46010
Spain
Calle Sinesio Delgado 10
Madrid
28029
Spain
Sponsor information
University/education
Avda. Blasco Ibanez 13
Valencia
46010
Spain
| Phone | +34 (0)963864417 |
|---|---|
| dolores.corella@uv.es | |
| Website | https://www.uv.es/ |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Valencia, 85|86
- Location
- Spain
Results and Publications
| Intention to publish date | 28/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Findings regarding the main hypothesis will be published first in international journals related to nutrition and obesity. Later publications will include further secondary analyses. Posters and oral communications in related scientific meetings are planned. |
| 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. |
Editorial Notes
14/07/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2020 to 15/06/2023.
2. The overall trial end date was changed from 18/12/2020 to 17/12/2023.
3. The intention to publish date was changed from 22/12/2021 to 28/12/2023.
12/05/2020: The recruitment end date was changed from 08/04/2020 to 30/09/2020.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
13/12/2019: Internal review.
13/12/2019: Trial's existence confirmed by the Ethics Committee at the University of Valencia.
