Study of Eating Patterns with a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome

December 3, 2024 updated by: Tinh-Hai Collet, MD, University of Lausanne Hospitals

Study of Eating Patterns with a Smartphone App and the Metabolic Effects of Time Restricted Feeding (TRF) in the Metabolic Syndrome - an Open-label Randomized Controlled Trial of TRF Vs Regular Dietary Advices

SwissChronoFood - Study of eating patterns with a smartphone app and the metabolic effects of time restricted feeding in metabolic syndrome

The purpose of this study is to assess eating patterns among teenagers and adults with a new method, going beyond the pen-and-paper food diaries, and to investigate whether time restricted feeding leads to weight loss, improvement in lipid and glucose metabolism in individuals with components of the metabolic syndrome

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 prevalence of the metabolic syndrome (MS) is increasing worldwide, due to the progression of its different components (central obesity, elevated blood pressure, impaired glucose tolerance and dyslipidemia), as well as the often associated liver steatosis. One way to tackle the obesity epidemic is to intervene early at the onset in childhood and teenage years - before cardio-metabolic complications have occurred. However, lifestyle programs targeting this age group had limited success in the current obesogenic environment. In particular, weight loss is a key factor in controlling all MS components, yet it is difficult to maintain over time.

Time restricted feeding (TRF) is an approach that emphasizes energy intake limited to certain windows of time within the 24-hour cycle without restrictions on calories or macronutrients. This has emerged as an appealing approach to reduce body weight while improving lipid profile and glucose metabolism. However, TRF has been mostly studied in animals and long-term prospective data on its efficacy and mechanisms in humans is lacking.

Prior to the intervention, the investigators will assess the eating patterns of participants with an innovative smartphone application ('app') which is less intrusive and more reliable than food diaries/questionnaires to assess eating behavior and patterns.

In this project, the investigators will assess eating patterns among teenagers and adults, and investigate whether a controlled TRF intervention leads to beneficial changes in MS components. Study Part 1 uses an epidemiological approach to establish baseline daily eating behavior, physical activity patterns and sleeping habits over 2 weeks (teenagers) and 4 weeks (adults) using the smartphone app. Those individuals meeting criteria for at least one component of MS and who have eaten for >14 hours per 24-hour cycle will be recruited for Study Part 2. In Part 2, participants will be assigned to TRF or active control groups, and followed in this pragmatic randomized controlled trial for 6 weeks (teenagers) and 6 months (adults) to assess the change in their weight and MS components, as well as liver fat deposits. Study Part 3 will investigate the underlying mechanisms of improved metabolic profile with TRF.

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.
235

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 Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • University Hospital of Lausanne (CHUV)
    • BE
      • Bern, BE, Switzerland, 3010
        • Inselspital, Klinik für Allgemeine Innere Medizin

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Key inclusion criteria for both observation and intervention phases (Part 1+2):

  • Age ≥ 12 years
  • Body mass index ≥ 20 kg/m2 and stable weight (previous 3 months) in adults; BMI ≥ 25th percentile in teenagers
  • Smartphone compatible with the app (iOS or Android systems)

Additional inclusion criteria for the intervention phase (Part 2):

  • Any component of the metabolic syndrome following the International Diabetes Federation consensus definition
  • Eating duration >14h during the observation phase

Additional inclusion criteria for the mechanistic study (Part 3):

  • Age 18-40 years, men and pre-menopausal women
  • BMI 30-40 kg/m2
  • In the fasting state (at least 8 hours)

Key exclusion criteria for both observation and intervention phases (Part 1+2):

  • Pregnant and breastfeeding women, plans for maternity during the study
  • Major illness/fever over the previous month, active cancer
  • Eating disorder, on a diet / weight management, prior bariatric surgery
  • Major mental illness, unable to give informed consent
  • Current shift work or travel abroad planned in the next month

Additional exclusion criteria for the intervention phase (Part 2):

  • Prior cardiovascular event
  • Major liver, gastrointestinal, renal or endocrine disorder, diabetes mellitus with hypoglycemic drug(s)
  • Major sleep disorder, centrally acting medication
  • Lipid lowering drug, hypoglycemic drug, medication affecting the gut

Additional exclusion criteria for the mechanistic study (Part 3):

  • Impaired glucose tolerance (pre-diabetes) or diabetes mellitus
  • Positive pregnancy test

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: Parallel 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: Time restricted feeding
For those in the intervention phase (Part 2)
Behavioral: Time restricted feeding
To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake
Device: Eating patterns
Data collection on eating patterns via the smartphone app
Active Comparator: Regular dietary advices
For those in the intervention phase (Part 2)
Device: Eating patterns
Data collection on eating patterns via the smartphone app
Behavioral: Regular dietary advices
Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines

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
Eating duration
Time Frame: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)

Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app.

Note: Key inclusion criterion for the intervention phase (Part 2).
From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)
Change of metabolic syndrome components
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)

Number of participants with changes in weight and/or lipid profile and/or glucose metabolism in the intervention phase (Part 2).

Note: Changes of the different components will be analyzed separately as secondary outcomes.
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)

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
Adherence to TRF intervention
Time Frame: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
After allocation to the TRF arm, assessment of the adherence to the intervention, as measured by eating duration from the first to last caloric intake over 24-hour cycle.
From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
Weight change
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Part of the composite primary outcome in the intervention phase (Part 2)
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in lipid profile
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Part of the composite primary outcome in the intervention phase (Part 2)
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in glucose metabolism
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Part of the composite primary outcome in the intervention phase (Part 2)
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in blood pressure
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Systolic and diastolic blood pressure
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in hepatic steatosis / fibrosis score
Time Frame: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
As measured by the Fibroscan device
From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
Change in number of meals per day
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Temporal analysis of caloric intake events collected by the smartphone app
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in meal intervals
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Temporal analysis of caloric intake events collected by the smartphone app
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in fraction of calories consumed after noon
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Estimation of caloric content from food pictures collected by the smartphone app
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in fraction of calories consumed after 6pm
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Estimation of caloric content from food pictures collected by the smartphone app
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in eating pattern difference between weekdays and weekends
Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Indirect assessment of different lifestyle habits during weekdays and weekends
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)

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
Change in fat mass
Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
Body composition as measured by dual energy X-ray absorptiometry (DEXA)
From randomization visit to close-out visit (Part 3: 6 months, only adults)
Change in fat free mass
Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
Body composition as measured by dual energy X-ray absorptiometry (DEXA)
From randomization visit to close-out visit (Part 3: 6 months, only adults)
Change in diurnal rhythms of cortisol secretion
Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
Repeated measurements of cortisol over a 24-hour cycle
From randomization visit to close-out visit (Part 3: 6 months, only adults)
Change in diurnal rhythms of melatonin secretion
Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
Repeated measurements of melatonin over a 24-hour cycle
From randomization visit to close-out visit (Part 3: 6 months, only adults)
Change in physical activity
Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
As measured by actigraphy
From randomization visit to close-out visit (Part 3: 6 months, only adults)
Change in sleep/wake cycles
Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
As measured by actigraphy
From randomization visit to close-out visit (Part 3: 6 months, only adults)
Eating duration - alternative definition of the primary outcome
Time Frame: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)
Alternative definition of eating duration accounting for 2.5-97.5th percentiles of caloric intake over 24 hours, presumably less sensitive to the occasionally forgotten food picture event
From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)

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.
University of Lausanne Hospitals

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.
Salk Institute for Biological Studies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tinh-Hai Collet, MD, University of Lausanne Hospitals

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

Helpful Links

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.
September 29, 2017

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.
March 31, 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.
March 31, 2022

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 2, 2017

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.
August 2, 2017

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.
August 7, 2017

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.
December 6, 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.
December 3, 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.
  • 2017-00487
  • PZ00P3-167826 (Other Grant/Funding Number: Swiss National Science Foundation)
  • SSED-YI 2017 (Other Grant/Funding Number: Swiss Society of Endocrinology and Diabetes)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

Upon appropriate data request by other scientists

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Obesity

Clinical Trials on Time restricted feeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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