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

NCT ID: NCT07171281

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-19
• Study Completion Date: 2028-02-28

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 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.

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 the morning (early TRE) or predominantly in the afternoon (late TRE) - in conjunction with a moderate caloric restriction for five weeks. A 10-12-week washout phase will separate the intervention periods.

Overweight and obese individuals with healthy glucose metabolism, prediabetes, or non-insulin-treated type 2 diabetes will be recruited for the study.

Conditions

Prediabetes; Type 2 Diabetes; Obesity &Amp; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Time-Restricted Eating

Group Type: EXPERIMENTAL

Early Time-Restricted Eating

Intervention Type: 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

Group Type: EXPERIMENTAL

Late Time-Restricted Eating

Intervention Type: 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.

Interventions

Early Time-Restricted Eating

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.

Intervention Type: BEHAVIORAL

Late Time-Restricted Eating

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

eTRE; early TRE; LateTRE; lTRE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technische Universität Dresden, Germany

UNKNOWN

Sponsor Role: collaborator

University of Surrey, UK

UNKNOWN

Sponsor Role: collaborator

University of Geneva, Switzerland

OTHER

Sponsor Role: collaborator

Technische Universität München, Germany

UNKNOWN

Sponsor Role: collaborator

German Diabetes Center (DDZ), Germany

UNKNOWN

Sponsor Role: collaborator

University of Rovira i Virgili, Spain

UNKNOWN

Sponsor Role: collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role: lead

Responsible Party

Olga Ramich (formerly Pivovarova)

Head of Department Molecular Metabolism and Precision Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

German Institute of Human Nutrition Potsdam-Rehbruecke

Nuthetal, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Olga Ramich, Prof. Dr.

Role: CONTACT

olga.ramich@dife.de

+49 33200 882749

Bettina Schuppelius, M.Sc.

Role: CONTACT

bettina.schuppelius@dife.de

+49 33200 882692

Facility Contacts

Olga Ramich, Prof. Dr.

Role: primary

olga.ramich@dife.de

+49 33200 882749

Bettina Schuppelius, M.Sc.

Role: backup

bettina.schuppelius@dife.de

+49 33200 882692

Other Identifiers

TEMP643937-BO-ff

Identifier Type: OTHER

Identifier Source: secondary_id

85/2023

Identifier Type: -

Identifier Source: org_study_id