Eating BehaviorNCT03241121
Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
A study testing Time restricted feeding, Regular dietary advices and Eating patterns in people with Eating Behavior and Metabolic Syndrome, run by University of Lausanne Hospitals at 2 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Metabolic Syndrome, Obesity
- What is being tested?
- Time restricted feeding, Regular dietary advices and Eating patterns
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 29 Sep 2017to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Inselspital, Klinik für Allgemeine Innere Medizin
Bern, Canton of Bern, 3010
University Hospital of Lausanne (CHUV)
Lausanne, 1011
About this study
Official title: 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
Read the 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.
- Conditions
- Eating Behavior, Metabolic Syndrome, Obesity, Dyslipidemias, Glucose Intolerance, Steatosis of Liver
- Being tested
- Time restricted feeding, Regular dietary advices, Eating patterns
- Keywords
- Time Restricted Feeding, Eating patterns
- Medical subject headings
- Feeding Behavior, Metabolic Syndrome, Obesity, Dyslipidemias, Glucose Intolerance, Fatty Liver, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake
Regular dietary advicesBehavioural
Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines
Eating patternsDevice
Data collection on eating patterns via the smartphone app
| Study group | Role | What they receive |
|---|---|---|
| Time restricted feeding | Experimental | For those in the intervention phase (Part 2) Receives: Behavioral: Time restricted feeding; Device: Eating patterns |
| Regular dietary advices | Active comparator | For those in the intervention phase (Part 2) Receives: Behavioral: Regular dietary advices; Device: Eating patterns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating duration
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).
Measured: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)
Change of metabolic syndrome components
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.
Measured: 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 outcomes (11)
Adherence to TRF intervention
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.
Measured: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
Weight change
Part of the composite primary outcome in the intervention phase (Part 2)
Measured: 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
Part of the composite primary outcome in the intervention phase (Part 2)
Measured: 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
Part of the composite primary outcome in the intervention phase (Part 2)
Measured: 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
Systolic and diastolic blood pressure
Measured: 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
As measured by the Fibroscan device
Measured: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
Change in number of meals per day
Temporal analysis of caloric intake events collected by the smartphone app
Measured: 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
Temporal analysis of caloric intake events collected by the smartphone app
Measured: 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
Estimation of caloric content from food pictures collected by the smartphone app
Measured: 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
Estimation of caloric content from food pictures collected by the smartphone app
Measured: 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
Indirect assessment of different lifestyle habits during weekdays and weekends
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start29 Sep 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Part 1: Prospective longitudinal observational study. Study Part 2/3: Open-label randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Responsible party
- Principal investigator, Tinh-Hai Collet, MD, University of Lausanne Hospitals
- Investigators
- Tinh-Hai Collet, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241121
- Sponsor's protocol ID
- 2017-00487
- Other IDs
- PZ00P3-167826, SSED-YI 2017, 2017
- Status last verified
- Aug 2024
- First submitted
- 2 Apr 2017
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Buso G, Favre L, Vionnet N, Gonzalez-Rodriguez E, Hans D, Puder JJ, Dubath C, Eap CB, Raffoul W, Collet TH, Mazzolai L. Body Composition Assessment by Dual-Energy X-Ray Absorptiometry: A Useful Tool for the Diagnosis of Lipedema. Obes Facts. 2022;15(6):762-773. doi: 10.1159/000527138. Epub 2022 Oct 28.
PubMed 36310013Phillips NE, Mareschal J, Schwab N, Manoogian ENC, Borloz S, Ostinelli G, Gauthier-Jaques A, Umwali S, Gonzalez Rodriguez E, Aeberli D, Hans D, Panda S, Rodondi N, Naef F, Collet TH. The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults. Nutrients. 2021 Mar 23;13(3):1042. doi: 10.3390/nu13031042.
PubMed 33807102Borloz S, Bucher Della Torre S, Collet TH, Jotterand Chaparro C. Consumption of Ultraprocessed Foods in a Sample of Adolescents With Obesity and Its Association With the Food Educational Style of Their Parent: Observational Study. JMIR Pediatr Parent. 2021 Nov 15;4(4):e28608. doi: 10.2196/28608.
PubMed 34779776Papageorgiou M, Biver E, Mareschal J, Phillips NE, Hemmer A, Biolley E, Schwab N, Manoogian ENC, Gonzalez Rodriguez E, Aeberli D, Hans D, Pot C, Panda S, Rodondi N, Ferrari SL, Collet TH. The effects of time-restricted eating and weight loss on bone metabolism and health: a 6-month randomized controlled trial. Obesity (Silver Spring). 2023 Feb;31 Suppl 1(Suppl 1):85-95. doi: 10.1002/oby.23577. Epub 2022 Oct 14.
PubMed 36239695
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03241121
- Acronym / sponsor ID
- 2017-00487
- Conditions
- Eating Behavior, Metabolic Syndrome, Obesity, Dyslipidemias, Glucose Intolerance, Steatosis of Liver
- Keywords
- Time Restricted Feeding, Eating patterns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Part 1: Prospective longitudinal observational study. Study Part 2/3: Open-label randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Time restricted feeding | Experimental | Behavioral: Time restricted feeding, Device: Eating patternsFor those in the intervention phase (Part 2) |
| Regular dietary advices | Active comparator | Behavioral: Regular dietary advices, Device: Eating patternsFor those in the intervention phase (Part 2) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted feedingTo eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake | Behavioural | Time restricted feeding |
| Regular dietary advicesRegular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines | Behavioural | Regular dietary advices |
| Eating patternsData collection on eating patterns via the smartphone app | Device | Regular dietary advices, Time restricted feeding |
Primary outcome
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).
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.
11 secondary outcomes
Adherence to TRF intervention
Time frame: 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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Results publication: PubMed 36310013Buso G, Favre L, Vionnet N, Gonzalez-Rodriguez E, Hans D, Puder JJ, Dubath C, Eap CB, Raffoul W, Collet TH, Mazzolai L. Body Composition Assessment by Dual-Energy X-Ray Absorptiometry: A Useful Tool for the Diagnosis of Lipedema. Obes Facts. 2022;15(6):762-773. doi: 10.1159/000527138. Epub 2022 Oct 28.
- Results publication: PubMed 33807102Phillips NE, Mareschal J, Schwab N, Manoogian ENC, Borloz S, Ostinelli G, Gauthier-Jaques A, Umwali S, Gonzalez Rodriguez E, Aeberli D, Hans D, Panda S, Rodondi N, Naef F, Collet TH. The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults. Nutrients. 2021 Mar 23;13(3):1042. doi: 10.3390/nu13031042.
- Results publication: PubMed 34779776Borloz S, Bucher Della Torre S, Collet TH, Jotterand Chaparro C. Consumption of Ultraprocessed Foods in a Sample of Adolescents With Obesity and Its Association With the Food Educational Style of Their Parent: Observational Study. JMIR Pediatr Parent. 2021 Nov 15;4(4):e28608. doi: 10.2196/28608.
- Results publication: PubMed 36239695Papageorgiou M, Biver E, Mareschal J, Phillips NE, Hemmer A, Biolley E, Schwab N, Manoogian ENC, Gonzalez Rodriguez E, Aeberli D, Hans D, Pot C, Panda S, Rodondi N, Ferrari SL, Collet TH. The effects of time-restricted eating and weight loss on bone metabolism and health: a 6-month randomized controlled trial. Obesity (Silver Spring). 2023 Feb;31 Suppl 1(Suppl 1):85-95. doi: 10.1002/oby.23577. Epub 2022 Oct 14.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tinh-Hai Collet, MD principal investigator
University of Lausanne Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted feeding, Regular dietary advices and Eating patterns in people with Eating Behavior and Metabolic Syndrome, run by University of Lausanne Hospitals at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating duration (time frame: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03241121, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.