Condition category
Not Applicable
Date applied
11/12/2019
Date assigned
13/12/2019
Last edited
12/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

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 2020

Who is funding the study?
University of Valencia (Spain)

Who is the main contact?
Prof. José V. Sorlí
sorli@uv.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose V Sorlí

ORCID ID

http://orcid.org/0000-0002-0130-2006

Contact details

Avda. Blasco Ibanez 15
Valencia
46010
Spain
+34 (0)963864417
sorli@uv.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PCT1E-19

Study information

Scientific title

Effect of 24-hour fasting versus frequent meals on selected gene expression and methylation: a cross-over randomized and controlled trial

Acronym

FASTING-24

Study hypothesis

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

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

Study design

Interventional randomised cross over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

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 trial start date

14/10/2019

Overall trial end date

18/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Volunteers recruited from the general population
2. Between 25 and 50 years old
2. BMI between 23 and 33 kg/m2

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

10

Participant 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

Recruitment start date

20/12/2019

Recruitment end date

30/09/2020

Locations

Countries of recruitment

Spain

Trial participating centre

University of Valencia
School of Medicine Avda. Blasco Ibanez 15
Valencia
46010
Spain

Trial participating centre

CIBER OBN
Instituto de Salud Carlos III Calle Sinesio Delgado 10
Madrid
28029
Spain

Sponsor information

Organisation

University of Valencia

Sponsor details

Avda. Blasco Ibanez 13
Valencia
46010
Spain
+34 (0)963864417
dolores.corella@uv.es

Sponsor type

University/education

Website

https://www.uv.es/

Funders

Funder type

University/education

Funder name

Universitat de València

Alternative name(s)

University of Valencia, 85|86

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

Spain

Results and Publications

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 statement
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.

Intention to publish date

22/12/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.