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

ConditionsPrediabetesType 2 DiabetesObesity &Amp; Overweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGerman Institute of Human Nutrition

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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%)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Early Time-Restricted EatingExperimental treatment 1 intervention
Group B: Late Time-Restricted EatingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean 24-hour glucose

Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)

Time frame
5 weeks

Secondary outcomes

1

Glycemic variability

Inter- and intraday indices of glycemic variability assessed by CGM

Time frame
5 weeks
2

Glucose levels

Fasting and postprandial glucose \[mg/dL\] in response to a mixed meal tolerance test

Time frame
5 weeks
3

Insulin levels

Fasting and postprandial insulin \[mU/L\] in response to a mixed meal tolerance test

Time frame
5 weeks
4

Glucagon levels

Fasting and postprandial glucagon \[pmol/L\] in response to a mixed meal tolerance test

Time frame
5 weeks

Other outcomes

1

Physical activity level

24-h physical activity level (light, moderate, sedentary activity, metabolic equivalent of task) will be monitored by an Actigraph device

Time frame
5 weeks
2

Liver enzyme levels and renal values

γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT), and alanine aminotransferase (AST), creatinine, urea, uric acid determined in fasting blood samples

Time frame
5 weeks
3

Food intake

Energy intake \[kcal/day\] assessed by food records

Time frame
5 weeks
4

Macronutrient intake

Percentage of calories from fat, carbohydrates, protein, and fiber, determined based on dietary records

Time frame
5 weeks

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

German Institute of Human Nutrition Potsdam-RehbrueckeRecruiting14558, NuthetalGermanyGermany

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German Institute of Human Nutrition

Lead sponsor

Technische Universität Dresden

Collaborator

University of Surrey

Collaborator

University of Geneva, Switzerland

Collaborator

Technische Universität München, Germany

Collaborator

German Center for Diabetes Research

Collaborator

University of Rovira i Virgili, Spain

Collaborator

Source ClinicalTrials.gov
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