Effect of Timed-Restricted Eating on Metabolic Health

NCT06061042 | Recruiting DMC

• 1 other identifier: NL79197.018.21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Non-Alcoholic Fatty Liver Disease; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  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.

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

Secondary Outcomes (19)

• Change in plasma insulin

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

• Change in plasma glucose

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

• Change in intrahepatic fat

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

• Change in beta cell function (C-peptide)

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

• Change in insulin aignaling

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

Study Arms (2)

Early time-restricted eating

EXPERIMENTAL

* 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.

Behavioral: Early time restricted eating

Late time-restricted eating

EXPERIMENTAL

* 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.

Behavioral: Late time restricted eating

Interventions

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

Also known as: early-TRE

Early time-restricted eating

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

Also known as: late-TRE

Late time-restricted eating

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• For women, 1 year after last menstrual cycle

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Diabetesfonds: collaborator

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Mireille JM Serlie, MD PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jur Kroon, BSc

CONTACT

+31 683238752; jur.kroon@amsterdamumc.nl

Sarah E Siegelaar, MD PhD

CONTACT

s.e.siegelaar@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: September 29, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 29, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)