Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2023-10-31
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early time-restricted eating
* 50% of daily calories at breakfast, 35% at lunch and 15% at dinner. 85% of calories consumed in 6h, i.e., between 7AM and 1PM.
* Eating period, 10h (7AM-5PM); fasting period, 14h; Breakfast between 7 and 8 AM; lunch between 12 AM and 1 PM; dinner between 4 and 5 PM.
Early time restricted eating
Subjects will follow an isocaloric diet, designed by a dietician. The eating window for the early-TRE group is between 7 AM - 5 PM
Late time-restricted eating
* 15% of daily calories at breakfast, 35% at lunch and 50% at dinner. 85% of calories consumed in 6h, i.e., between 2PM and 8PM.
* Eating period, 10h (10AM-8PM), fasting period, 14h; Breakfast between 10 and 11 AM; lunch between 2 and 3 PM; dinner between 7 and 8 PM.
Late time restricted eating
Subjects will follow an isocaloric diet, designed by a dietician. The eating window for the late-TRE group is between 10 AM - 8 PM
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Early time restricted eating
Subjects will follow an isocaloric diet, designed by a dietician. The eating window for the early-TRE group is between 7 AM - 5 PM
Late time restricted eating
Subjects will follow an isocaloric diet, designed by a dietician. The eating window for the late-TRE group is between 10 AM - 8 PM
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Diabetesfonds
UNKNOWN
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Mireille JM Serlie
MD PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mireille JM Serlie, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jur Kroon, BSc
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL79197.018.21
Identifier Type: -
Identifier Source: org_study_id