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

Sponsor: German Institute of Human Nutrition • ClinicalTrials.gov ID: NCT07171281

Registry updated: 2026-09-29

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Description

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.

Interventions

Early Time-Restricted Eating (Behavioral)
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.
Late Time-Restricted Eating (Behavioral)
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.

Eligibility criteria

Inclusion Criteria: * Overweight or obesity (BMI 25-40 kg/m²) * Healthy glucose metabolism (fasting glucose \<100 mg/dl and glucose after 2 hours OGTT \<140 mg/dl) * OR impaired glucose metabolism (fasting glucose 100-125 mg/dl and/or glucose after 2 hours OGTT 140-199 mg/dl and/or HbA1c 5.7-6.4%) * OR type 2 diabetes (according to existing medical diagnosis or fasting glucose \>126 mg/dl and/or glucose after 2 hours OGTT \>200 mg/dl and/or HbA1c ≥6.5%) * Daily eating window ≥12 hours Exclusion Criteria: * Weight changes \> 5% within past 3 months * Shift work * Traveling across more than one time zone within one month prior to the study * Pregnancy and breastfeeding * Eating disorders, food intolerance/allergy to ingredients in the diet product, vegan diet, practicing time-restricted eating * Severe chronic illnesses or other conditions that are incompatible with the planned intervention and examination program (e.g. type 1 diabetes, recent cardiovascular event, malabsorption, cancer in the last two years, etc.) * Treatment with insulin, sulfonylureas, and GLP-1 receptor agonists, steroid use (oral, cutaneous, or parenteral), regular intake of melatonin, anticoagulation treatment that cannot be paused * Extreme early and extreme late chronotypes

Conditions

Prediabetes Type 2 Diabetes Obesity &Amp; Overweight

Locations

German Institute of Human Nutrition Potsdam-Rehbruecke — Nuthetal, Germany

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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