Status:
RECRUITING
Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes
Lead Sponsor:
German Institute of Human Nutrition
Collaborating Sponsors:
Technische Universität Dresden, Germany
University of Surrey, UK
Conditions:
Prediabetes
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 para...
Detailed Description
This dietary intervention study will follow a crossover design. During the intervention phases, participants will restrict their dietary intake to a defined eating window of 8 hours - predominantly in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07171281
Start Date
September 19 2025
End Date
February 28 2028
Last Update
September 12 2025
Active Locations (1)
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1
German Institute of Human Nutrition Potsdam-Rehbruecke
Nuthetal, Germany, 14558