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

August 21, 2024 updated by: Olga Ramich (formerly Pivovarova), German Institute of Human Nutrition
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Nuthetal, Germany, 14558
        • German Institute of Human Nutrition Potsdam-Rehbruecke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Time-Restricted Feeding
Behavioral: Early Time-Restricted Feeding
Eat between 8 am and 4 pm for two weeks
Other Names:
  • Early TRF
  • eTRF
Experimental: Late Time-Restricted Feeding
Behavioral: Late Time-Restricted Feeding
Eat between 1 pm and 9 pm for two weeks
Other Names:
  • Late TRF
  • lTRF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 2 weeks
Assessed using Matsuda index in oral glucose tolerance test (OGTT)
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolic hormones and inflammatory markers
Time Frame: 2 weeks
Levels of hormones related to the glucose metabolism, hormones of appetite regulation, adipokines and inflammatory markers
2 weeks
Blood lipids
Time Frame: 2 weeks
Total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides
2 weeks
Satiety and hunger scores
Time Frame: 2 weeks
Assessed using Visual Analog Scales (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)
2 weeks
Expression of metabolic genes in adipose tissue
Time Frame: 2 weeks
RNA-Seq analysis of subcutaneous adipose tissue samples
2 weeks
Social and economic decision behaviour
Time Frame: 2 weeks
Assessed by computer tests together with the Barratt Impulsiveness Scale short version (BIS-15 with a score between 15 and 60, where higher values correspond to higher impulsiveness) and the UCLA Loneliness Scale (with a score between 20 and 100, where higher values correspond to higher subjectively perceived loneliness)
2 weeks
Glucose tolerance, fasting glucose, and overall daily glycemic variation
Time Frame: 2 weeks (OGTT) and 14 days (CGM)
Assessed by glucose area under the curve in OGTT and using a continuous glucose monitoring (CGM)
2 weeks (OGTT) and 14 days (CGM)
Oxidative stress markers
Time Frame: 2 weeks
Malondialdehyde, 3-nitrotyrosine, and protein carbonyls
2 weeks
Blood pressure
Time Frame: 2 weeks
Systolic and diastolic blood pressure
2 weeks
Liver enzymes
Time Frame: 2 weeks
γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT), and alanine aminotransferase (AST)
2 weeks
Anthropometric parameters: body weight
Time Frame: 2 weeks
Body weight in kilograms
2 weeks
Anthropometric parameters: BMI
Time Frame: 2 weeks
BMI in kg/m^2
2 weeks
Anthropometric parameters: waist circumference
Time Frame: 2 weeks
Waist circumference in centimeters
2 weeks
Anthropometric parameters: fat and lean mass
Time Frame: 2 weeks
Fat and lean mass in kilograms assessed by bioelectrical impedance analysis
2 weeks
Food intake: eating times
Time Frame: 14 days
Eating times in hours and minutes as assessed by food records
14 days
Food intake: calorie intake
Time Frame: 14 days
Calorie intake in kilocalories as assessed by food records
14 days
Food intake: macronutrient composition
Time Frame: 14 days
Macronutrient composition in percentage of energy intake as assessed by food records
14 days
Sleep quality and timing
Time Frame: 2 weeks (PSQI) and 14 days (ActiGraph, sleep diary)
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality) and by the ActiGraph device; sleep timing (sleep onset and offset) as monitored using a sleep diary
2 weeks (PSQI) and 14 days (ActiGraph, sleep diary)
Physical activity
Time Frame: 14 days
24-h physical activity as monitored by an ActiGraph device
14 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gene expression in peripheral mononuclear blood cells (PBMC)
Time Frame: 2 weeks
mRNA expression of clock, metabolic and inflammatory genes
2 weeks
Internal circadian phase
Time Frame: 2 weeks
Circadian phase as assessed using the BodyTime assay in isolated CD14+ blood monocytes
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
German Institute of Human Nutrition

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
University of Potsdam
Immanuel Krankenhaus Berlin, Germany
Hasso-Plattner Institut, Potsdam, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DFG RA 3340/3-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings