Effect of Timed-Restricted Eating on Metabolic Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early time restricted eating, Late time restricted eating.
- Who it may be relevant to
- Registry conditions: Obesity, Non-Alcoholic Fatty Liver Disease, Insulin Resistance. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Timed-Restricted Eating on Insulin Sensitivity, De Novo Lipogenesis and Liver Fat in Subjects With Obesity and Insulin Resistance
Overview
We aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance.
Detailed description
Obesity is an alarming global health issue, with increasing prevalence. Obesity leads to a vast array of disorders, including dyslipidemia, the accumulation of intrahepatic triglycerides (IHTG), multiorgan insulin resistance and type 2 diabetes mellitus. In addition, disruption of the circadian rhythm (circadian misalignment), which is associated with irregular eating schedules, is an important risk factor for the development of obesity, IHTG and type 2 diabetes mellitus. Time restricted eating (TRE) is a form of intermittent fasting, in which the daily eating period is restricted. The beneficial effect of this type of diet might relate to adequate synchronization of food intake and fasting to the internal rhythm of the circadian tissue clocks, improving metabolic handling of nutrients and metabolic flexibility.
Interventions
- Behavioral 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 - Behavioral 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
Primary outcome measures
- Insulin Sensitivity [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
Secondary outcome measures (12)
- Change in plasma insulin [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in plasma glucose [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in intrahepatic fat [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in beta cell function (C-peptide) [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in insulin aignaling [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in glucose variability [Time frame: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2]
- De novo lipogenesis [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Immunological markers [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Physical activity [Time frame: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2]
- Functional brain activity [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Psychological factor - Food Craving [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Psychological factor - Eating behaviour [Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Amsterdam UMC, location AMC — Amsterdam
Identifiers
NCT: NCT06061042 · NL79197.018.21