Timed-Restricted Eating for Improving Metabolic Health
The Effect of Timed-Restricted Eating on Insulin Sensitivity, De Novo Lipogenesis and Liver Fat in Subjects With Obesity and Insulin Resistance
This study is testing whether changing when people with obesity and insulin resistance eat can improve their metabolic health, liver fat, brain function, inflammation, and sleep quality.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06061042 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of isocaloric timed-restricted eating (TRE) on metabolic health, liver fat, brain function, inflammation, and sleep quality in individuals with obesity and insulin resistance. Participants will be assigned to either early or late TRE schedules to assess how meal timing influences their metabolic outcomes. The study aims to align eating patterns with the body's circadian rhythms to enhance metabolic flexibility and overall health. By examining these factors, the research seeks to provide insights into effective dietary interventions for obesity-related conditions.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI over 30 and diagnosed with insulin resistance or prediabetes.
Not a fit: Patients with psychiatric disorders, those on certain medications, or individuals with specific dietary intolerances may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve metabolic health and reduce the risk of obesity-related diseases.
How similar studies have performed: Previous studies on timed-restricted eating have shown promising results in improving metabolic health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to provide informed consent; * BMI \> 30kg/m\^2; * Insulin resistance, as defined by fasting plasma insulin \> 62 pmol/L and/or prediabetes, as defined by fasting plasma glucose \> 5.3 and \< 7.0 mmol/L; * Stable weight for 3 months prior to study inclusion * For women, 1 year after last menstrual cycle Exclusion Criteria: * Use of any medication, except for those related to treatment of metabolic syndrome; * Any medical condition interfering with study outcomes or design; * History of any psychiatric disorder, including eating disorders; * Performing shift work * Performing intensive sports (\>3 hours/week); * Smoking; * Drugs abuse or alcohol abuse (\>3 units/day); * Contraindication for MRI; * Known lactose/gluten intolerance; * Known soy, egg, milk or peanut allergy; * Childhood onset of obesity
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Mireille JM Serlie, MD PhD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Jur Kroon, BSc
- Email: jur.kroon@amsterdamumc.nl
- Phone: +31 683238752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.