Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes
Recruiting · NCT07171281 · Interventional (participants receive a specific treatment) · Lead sponsor: German Institute of Human Nutrition
View the official record on ClinicalTrials.gov →Interventions studied
Early Time-Restricted EatingLate Time-Restricted Eating
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- German Institute of Human Nutrition Potsdam-Rehbruecke - Nuthetal, Germany