Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans
ChronoFast
1 other identifier
interventional
31
1 country
1
Brief Summary
This human dietary intervention study with a cross-over design aims to compare the effects of two isocaloric diets - early time-restricted feeding (TRF) vs. late TRF - on glycemic control and lipid metabolism in overweight and obese women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedStudy Start
First participant enrolled
June 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedAugust 26, 2024
August 1, 2024
1.5 years
April 7, 2020
August 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin sensitivity
Assessed using Matsuda index in oral glucose tolerance test (OGTT)
2 weeks
Secondary Outcomes (18)
Glucose tolerance, fasting glucose, and overall daily glycemic variation
2 weeks (OGTT) and 14 days (CGM)
Metabolic hormones and inflammatory markers
2 weeks
Oxidative stress markers
2 weeks
Blood lipids
2 weeks
Blood pressure
2 weeks
- +13 more secondary outcomes
Other Outcomes (2)
Gene expression in peripheral mononuclear blood cells (PBMC)
2 weeks
Internal circadian phase
2 weeks
Study Arms (2)
Early Time-Restricted Feeding
EXPERIMENTALLate Time-Restricted Feeding
EXPERIMENTALInterventions
Eat between 8 am and 4 pm for two weeks
Eat between 1 pm and 9 pm for two weeks
Eligibility Criteria
You may qualify if:
- BMI 25-35 kg/m²
You may not qualify if:
- prior diagnosis of type 1 or 2 diabetes
- weight changes \> 5% within past 3 months
- current shift work or history of shift work
- traveled across more than one time zone one month before the study
- poor quality of sleep (PSQI score\>10)
- eating disorders, food intolerance/allergy, severe indigestion
- Pregnant or breastfeeding
- severe internal or psychiatric disorders or other conditions that might influence the outcome of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- German Institute of Human Nutritionlead
- Charite University, Berlin, Germanycollaborator
- Immanuel Krankenhaus Berlin, Germanycollaborator
- Hasso-Plattner Institut, Potsdam, Germanycollaborator
- University of Potsdamcollaborator
Study Sites (1)
German Institute of Human Nutrition Potsdam-Rehbruecke
Nuthetal, 14558, Germany
Related Publications (1)
Peters B, Koppold-Liebscher DA, Schuppelius B, Steckhan N, Pfeiffer AFH, Kramer A, Michalsen A, Pivovarova-Ramich O. Effects of Early vs. Late Time-Restricted Eating on Cardiometabolic Health, Inflammation, and Sleep in Overweight and Obese Women: A Study Protocol for the ChronoFast Trial. Front Nutr. 2021 Nov 15;8:765543. doi: 10.3389/fnut.2021.765543. eCollection 2021.
PMID: 34869534DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- project director
Study Record Dates
First Submitted
April 7, 2020
First Posted
April 17, 2020
Study Start
June 23, 2020
Primary Completion
December 20, 2021
Study Completion
February 28, 2023
Last Updated
August 26, 2024
Record last verified: 2024-08