Effect of Timed-Restricted Eating on Metabolic Health

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT06061042
Status
Recruiting
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Conditions

  • Insulin Resistance
  • Non-Alcoholic Fatty Liver Disease
  • Obesity

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

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
  • 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

Study Details

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.

Key Dates

First listed
Sep 29, 2023
Start date
Oct 31, 2023
Status verified
Feb 2023
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Early time-restricted eating
    * 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.
  • Experimental: Late time-restricted eating
    * 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.

Primary Outcome Measure

Insulin Sensitivity [ Time Frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2 ]

Central Contacts

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