Clinical trial

Effect of Timed-Restricted Eating on Metabolic Health

Recruiting now · Not applicable · 1 countries · Registry ID NCT06061042

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age50 Years to 75 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Non-Alcoholic Fatty Liver Disease, Insulin Resistance

Full registry 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

Treatments and study arms

Early time restricted eating

Behavioral

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

Behavioral

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 outcomes

Insulin SensitivityBaseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2

We will use the Oral Minimal Model Method in conjunction with a Mixed Meal Tolerance Test (MMTT) to quantitatively evaluate insulin sensitivity. Concentrations of insulin, glucose, and C-peptide will be measured during the course of the MMTT to serve as the requisite inputs for the model. The output is in dl/kg/min/uU/ml.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Amsterdam UMC, location AMC🇳🇱 Amsterdam, North Holland, Netherlands

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Jur Kroon, BScContact

Email · Call +31 683238752

Jur Kroon, BScSub Investigator