RecruitingNot ApplicableNCT07171281

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

Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes: the GLYCOTIME Trial

Sponsor

German Institute of Human Nutrition

Enrollment

30 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Conditions

Prediabetes Type 2 Diabetes Obesity &Amp; Overweight

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether eating meals within a specific time window each day (called time-restricted eating) can improve blood sugar control and heart health in people who are overweight and have normal blood sugar, prediabetes, or type 2 diabetes. **You may be eligible if...** - You are overweight or obese (BMI between 25 and 40) - You have normal blood sugar, prediabetes, or type 2 diabetes - You currently eat across a window of 12 or more hours each day **You may NOT be eligible if...** - Your weight has changed more than 5% in the past 3 months - You work night shifts or recently traveled across time zones - You are pregnant or breastfeeding - You have an eating disorder, severe food allergy, or follow a vegan diet - You have type 1 diabetes, recent heart attack or stroke, cancer in the last 2 years, or other serious illness - You take insulin, sulfonylureas, GLP-1 receptor agonists (like Ozempic), or steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEarly 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.

BEHAVIORALLate 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.