Status:

RECRUITING

Effect of Timed-Restricted Eating on Metabolic Health

Lead Sponsor:

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

Collaborating Sponsors:

Diabetesfonds

Conditions:

Obesity

Non-Alcoholic Fatty Liver Disease

Eligibility:

All Genders

50-75 years

Phase:

NA

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 subje...

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), multi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06061042

Start Date

October 1 2023

End Date

December 1 2027

Last Update

September 29 2023

Active Locations (1)

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1

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands, 1105AZ