Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes

Summary

The objective of this study is to investigate the impact of hypocaloric time-restricted eating (TRE) at different day times (early versus late TRE) on glucose metabolism and other cardiometabolic parameters in individuals with overweight and with normal, or impaired glucose metabolism (prediabetes and type 2 diabetes). In addition, the study aims to elucidate the molecular mechanisms underlying these effects.

Conditions

• Prediabetes
• Type 2 Diabetes
• Obesity &Amp; Overweight

Interventions

BEHAVIORAL

Early Time-Restricted Eating

Participants will restrict their eating window (8 hours eating and 16 hours fasting per day) and caloric intake moderately. During the early TRE intervention, participants will primarily consume their meals in the morning. The precise eating window will be defined based on the individual chronotype of the participants. Additionally, participants will be required to reduce their daily caloric consumption by 25%. They will replace one daily meal with a calorie-reduced product to facilitate caloric restriction.

BEHAVIORAL

Late Time-Restricted Eating

Participants will restrict their eating window (8 hours eating and 16 hours fasting per day) and caloric intake moderately. During the late TRE intervention, participants will primarily consume their meals in the evening. The precise eating window will be defined based on the individual chronotype of the participants. Additionally, participants will be required to reduce their daily caloric consumption by 25%. They will replace one daily meal with a calorie-reduced product to facilitate caloric restriction.

Sponsors & Collaborators

• Technische Universität Dresden, Germany

  collaborator UNKNOWN

• University of Surrey, UK

  collaborator UNKNOWN

• University of Geneva, Switzerland

  collaborator OTHER

• Technische Universität München, Germany

  collaborator UNKNOWN

• German Diabetes Center (DDZ), Germany

  collaborator UNKNOWN

• University of Rovira i Virgili, Spain

  collaborator UNKNOWN

• German Institute of Human Nutrition

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-19

Primary Completion

2027-12-31

Completion

2028-02-28

Countries

• Germany