The effects of timed-restricted eating on insulin sensitivity, de novo lipogenesis and liver fat in subjects with obesity and insulin resistance

The effects of timed-restricted eating on insulin sensitivity, de novo lipogenesis and liver fat in subjects with obesity and insulin resistance - TREAT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51439

Enrollment

Registered

2022-04-20

Start date

2024-01-05

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity overweight

Interventions

Diet intervention in which subjects will adhere to an isocaloric time-restricted diet (eating period of 10h, followed by a 14h fast) with either most of the calories in the morning or most of the ca

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Ability to provide informed consent; - Age >50 years; - BMI >30kg/m2; - Insulin resistance, as reflected by fasting plasma insulin >62pmol/L and/or fasting plasma glucose > 5.5 and

Exclusion criteria

Exclusion criteria: - Use of any medication except for those related to treatment of the metabolic syndrome or adequately dosed levothyroxine in patients with hypothyroidism;; - Any medical condition interfering with the study outcomes or design; - History of any psychiatric disorder, including eating disorders (anorexia, binge eating, bulimia); - Performing shift work; - Performing intensive sports (>3/week); - Smoking; - Drugs of abuse; - Alcohol abuse (>3 units/day); - Contraindication for MRI (e.g. pacemaker, claustrophobia); - Known lactose/gluten intolerance; - Known soy, egg, milk, or peanut allergy; - Childhood onset of obesity (

Design outcomes

Primary

Measure	Time frame
insulin sensitivity, measured by indices of systemic insulin sensitivity and indices derived from mixed-meal tolerance measurements	—

Secondary

Measure	Time frame
- liver fat content (degree of hepatic steatosis); - de novo lipogenesis, basal and in response to a meal; - beta cell function; - glucoregulatory and liporegulatory hormones (including incretins), immunologic markers; - movement activity; - brain activity assessed as the induced change in BOLD and ASL signals and resting state brain connectivity measured with fMRI; - neuropsychological functioning and feeding behaviour characteristics assessed by questionnaires and tasks; - assessments of motivation and impulse control of feeding behaviour (questionnaires); - assessment of craving and hunger (questionnaires);	—

Measure

Time frame

- liver fat content (degree of hepatic steatosis); - de novo lipogenesis, basal and in response to a meal; - beta cell function; - glucoregulatory and liporegulatory hormones (including incretins), immunologic markers; - movement activity; - brain activity assessed as the induced change in BOLD and ASL signals and resting state brain connectivity measured with fMRI; - neuropsychological functioning and feeding behaviour characteristics assessed by questionnaires and tasks; - assessments of motivation and impulse control of feeding behaviour (questionnaires); - assessment of craving and hunger (questionnaires);

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)