Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes
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).
| Condition(s) | Prediabetes, Type 2 Diabetes, Obesity &Amp; Overweight |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 eati |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | German Institute of Human Nutrition |
| Locations | Nuthetal, Germany |
| Start date | 2025-09-19 |
| NCT ID | NCT07171281 |
| Official listing | https://clinicaltrials.gov/study/NCT07171281 |