Clinical trial NCT06061042: Effect of Timed-Restricted Eating on Metabolic Health
Official title: The Effect of Timed-Restricted Eating on Insulin Sensitivity, De Novo Lipogenesis and Liver Fat in Subjects With Obesity and Insulin Resistance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Non-Alcoholic Fatty Liver Disease
Insulin Resistance
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Diabetesfonds
First posted: 2023-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Secondary outcomes:
measure: Change in plasma insulin
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Change in plasma glucose
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Change in intrahepatic fat
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Change in beta cell function (C-peptide)
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Change in insulin aignaling
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Change in glucose variability
timeFrame: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2
measure: De novo lipogenesis
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Immunological markers
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Physical activity
timeFrame: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2
measure: Functional brain activity
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Psychological factor - Food Craving
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Psychological factor - Eating behaviour
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Psychological factor - Hunger scale
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Psychological factor - Food addiction
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Psychological factor - Impulsiveness
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Psychological factor - Chronotype
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Subject experience with intervention
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Delay discounting computational task
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
measure: Iowa gambling computational task
timeFrame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
state: Noord-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Mireille JM Serlie, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: