Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans

NCT ID: NCT04351672

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-23

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The participants are randomly allocated to one of two study groups: In study group (A) participants will begin with the early TRF (e-TRF) intervention. They will consume their habitual food (and the habitual daily amount of food) between 8 am and 4 pm for two weeks. After a washout-phase participants will conduct the late TRF (l-TRF) and consume their habitual food between 1 pm and 9 pm for another two weeks. Study group (B) receives the same interventions in the reversed order. Both dietary regimens will result in 8-hr eating period and 16-hr fasting period during the 24h day.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight and Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early Time-Restricted Feeding

Group Type EXPERIMENTAL

Early Time-Restricted Feeding

Intervention Type BEHAVIORAL

Eat between 8 am and 4 pm for two weeks

Late Time-Restricted Feeding

Group Type EXPERIMENTAL

Late Time-Restricted Feeding

Intervention Type BEHAVIORAL

Eat between 1 pm and 9 pm for two weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Early Time-Restricted Feeding

Eat between 8 am and 4 pm for two weeks

Intervention Type BEHAVIORAL

Late Time-Restricted Feeding

Eat between 1 pm and 9 pm for two weeks

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Early TRF eTRF Late TRF lTRF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMI 25-35 kg/m²

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Immanuel Krankenhaus Berlin, Germany

UNKNOWN

Sponsor Role collaborator

Hasso-Plattner Institut, Potsdam, Germany

UNKNOWN

Sponsor Role collaborator

University of Potsdam

OTHER

Sponsor Role collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Olga Ramich (formerly Pivovarova)

project director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

German Institute of Human Nutrition Potsdam-Rehbruecke

Nuthetal, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34869534 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DFG RA 3340/3-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.