Does a 24-h fasting period change gene expression and methylation in comparison with a frequent meal pattern?

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13161183

Enrollment

Registered

2019-12-13

Start date

2019-12-20

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of fasting and a regular meal pattern on gene expression Not Applicable

Interventions

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 compu

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026