Effect of Timed-Restricted Eating on Metabolic Health (TREAT)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Insulin Resistance; Obesity; Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: Late time restricted eating; Behavioral: Early time restricted eating

Study type: Interventional

Funder types: Other

Identifiers

NCT06061042

NL79197.018.21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Early time-restricted eating

Experimental group

Description:

* 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.

Treatment:

Behavioral: Early time restricted eating

Late time-restricted eating

Experimental group

Description:

* 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.

Treatment:

Behavioral: Late time restricted eating