Metabolic SyndromeTREMNIOSNCT04328233
Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome
A study testing Time-Restricted Eating in people with Metabolic Syndrome and Overweight or Obesity, run by Nicolaus Copernicus University at 1 site in Poland.
Trial summary
The main purpose of the clinical trial is to determine the health impact of a dietary intervention known as time-restricted eating (TRE) in patients with metabolic syndrome (defined as the presence of elevated fasting plasma glucose and two or more of the following criteria: increased waist circumference, elevated… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome, Overweight or Obesity, PreDiabetes
- What is being tested?
- Time-Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 sitePoland
- Study dates
- 31 Oct 2019to 30 Dec 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metabolic syndrome, defined as the presence of elevated fasting plasma glucose ≥ 100 mg/dL and two or more of the following criteria:
- Elevated waist circumference: ≥ 102 cm in men, ≥ 88 cm in women; Fasting plasma triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides); Reduced High-density lipoprotein (HDL)-cholesterol < 40 mg/dL in men, < 50 mg/dL in women (or drug treatment for reduced HDL-cholesterol); Elevated blood pressure, Systolic blood pressure ≥ 130 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg (or drug treatment for hypertension).
- BMI > 25
- Duration of eating period ≥ 14 hours/day.
- Own a Smartphone with Apple Operating System (OS) or Android OS.
Who cannot join
- Diagnosis of diabetes.
- Pregnant or lactating women.
- Active smoking or illicit drug use or history of treatment for alcohol abuse.
- Shift work.
- Caregivers for dependent requiring nocturnal care.
- Planned travel over time zones during the study period.
Show all 16Show fewer
- History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack) or current uncontrolled arrhythmia.
- Uncontrolled medical conditions due to rheumatologic, hematologic, oncologic, infectious, gastrointestinal, psychiatric, nephrological, or endocrine diseases.
- Known history of an eating disorder.
- Currently enrolled in a weight-loss or weight-management program.
- Special or prescribed diet for other reasons (e.g. Celiac disease).
- Current treatment with antidepressants, medications affecting appetite, or immunosuppression.
- History of bariatric surgery.
- A score of > 16 on the Epworth Sleepiness Scale.
- Depression determined by the Beck Depression Inventory.
- Failure to use the smartphone app for documentation during a 2-week baseline period.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
Bydgoszcz
About this study
Official title: Impact of Time-Restricted Eating on Metabolic and Neuroendocrine Homeostasis, Inflammation and Oxidative Stress in Patients With Metabolic Syndrome: the TREMNIOS Pilot Clinical Trial
The main purpose of the clinical trial is to determine the health impact of a dietary intervention known as time-restricted eating (TRE) in patients with metabolic syndrome (defined as the presence of elevated fasting plasma glucose and two or more of the following criteria: increased waist circumference, elevated fasting plasma triglycerides, reduced high-density lipoprotein-cholesterol, elevated blood pressure) and self-reported dietary intake of ≥14 hours per day. Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (myCircadianClock (mCC) app). Glucose homeostasis (blood glucose levels will be monitored continuously for 2 weeks at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention using a continuous glucose monitor), and other metabolic, neuroendocrine, inflammatory and oxidative stress/antioxidant defense biomarkers, body weight and composition, blood pressure, heart rate, sleep and activity (using mCC app), personal sense of wellness and dietary timing (using health questionnaires) will be evaluated at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention.
Read the detailed description
Metabolic syndrome occurs in approximately 30% of adults and is associated with increased risk of cardiovascular disease and type 2 diabetes. Circadian rhythm disruption due to lifestyle including erratic eating patterns may lead to metabolic and neuroendocrine dysfunction, inflammation, oxidative stress, and cardiometabolic diseases. Maintaining a daily rhythm of eating and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and metabolism. Recent studies support the notion that restricting a period of food intake to 8-12 hours a day (time-restricted eating, TRE) can prevent and reverse obesity and metabolic dysfunction.
The main purpose of the clinical trial is to determine the health impact of TRE in patients with metabolic syndrome (defined as the presence of elevated fasting plasma glucose and two or more of the following criteria: increased waist circumference, elevated fasting plasma triglycerides, reduced high-density lipoprotein-cholesterol, elevated blood pressure) and self-reported dietary intake of ≥14 hours per day. Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (myCircadianClock (mCC) app, developed by the Salk Institute for Biological Studies). The participants will select a 10-h eating window that best suits their lifestyle. All food/beverages except water must be consumed within the time-interval. No further dietary restrictions will be applied. The participants will be provided with behavioral nutritional counseling by a dietician. Glucose homeostasis (blood glucose levels will be monitored continuously for 2 weeks at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention using a continuous glucose monitor), and other metabolic, neuroendocrine, inflammatory and oxidative stress/antioxidant defense biomarkers, body weight and composition, blood pressure, heart rate, sleep and activity (using mCC app), personal sense of wellness and dietary timing (using health questionnaires) will be evaluated at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention. The investigators will assess for compliance with TRE using mCC app.
- Being tested
- Time-Restricted Eating
- Keywords
- Time-Restricted Eating, Circadian Rhythm, Glucose Homeostasis, Fasting, Metabolic Syndrome, Overweight, Obesity, PreDiabetes, Weight Loss, Metabolic Homeostasis, Neuroendocrine Biomarkers, Inflammation, Oxidative Stress
- Medical subject headings
- Metabolic Syndrome, Overweight, Obesity, Prediabetic State, Weight Loss, Intermittent Fasting, Fasting, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-Restricted EatingBehavioural
Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (mCC app). The participants will select a 10-h eating window that best suits their lifestyle. All food/beverages except water must be consumed within the time-interval. No further dietary restrictions will be applied. The participants will be provided with behavioral nutritional counseling by a dietician.
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Eating | Experimental | Not described Receives: Behavioral: Time-Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Body weight (kg) as measured in fasted state on a digital scale
Measured: Baseline and after 14 weeks
Change in fasting glucose concentration
Fasting plasma glucose concentration (mg/dl)
Measured: Baseline and after 14 weeks
Secondary outcomes (20)
Body weight
Body weight (kg) as measured in fasted state on a digital scale
Measured: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Body mass index
Body mass index (kg/m^2) as calculated from body weight (kg) and height (m)
Measured: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Mean glucose
Glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks
Measured: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Fasting glucose
Fasting glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks
Measured: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Lipids
Fasting blood concentrations of lipids: total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Measured: Changes from baseline. Measured in the blood in the fasted state at baseline, after 14 weeks, and after 26 weeks
Fat mass
Fat mass percentage (%) as measured by body composition analyzer (using bioelectric impendence technology)
Measured: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
HbA1c
HbA1c (%) assessed from blood samples
Measured: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Metabolic and neuroendocrine biomarkers
Fasting blood concentrations of metabolic and neuroendocrine biomarkers including but not limited to: free fatty acids, insulin, insulin-like growth factor-1, resistin, adiponectin, leptin, visfatin, irisin, ghrelin, omentin-1, and melatonin
Measured: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Inflammatory biomarkers
Fasting blood concentrations of inflammatory biomarkers including but not limited to: high sensitivity C-reactive protein, interleukin-6, interleukin-8, interleukin-10, tumor necrosis factor-α, tumor growth factor-β1, growth/differentiation factor 15
Measured: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Oxidative stress/antioxidant defense biomarkers
Fasting blood concentrations of oxidative stress/antioxidant defense biomarkers including but not limited to: superoxide dismutase-1, catalase, glutathione peroxidase, oxidized LDL, thiobarbituric acid reactive substances, conjugated dienes, malondialdehyde, 4-hydroxynonenal, vitamin A, and vitamin E
Measured: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Waist circumference
Waist circumference (cm) as measured using tape measure
Measured: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Blood pressure
Systolic and diastolic blood pressure (mmHg) measured under resting and fasting conditions
Measured: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Heart rate
Heart rate (bpm) measured under resting conditions during measurements of blood pressure
Measured: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Energy intake
Energy intake (kcal/day) assessed from diet records
Measured: Registered at baseline, after 14 weeks, and after 26 weeks
Timing of dietary intake
Timing of dietary intake (hh:mm) assessed from diet records and from the chrono-nutrition questionnaire
Measured: Changes from baseline. Registered at baseline, after 14 weeks, and after 26 weeks
Self-reported sleepiness
Self-reported sleepiness as assessed from the questionnaire the Epworth Sleepiness Scale
Measured: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported sleep quality
Self-reported sleep quality as assessed from the questionnaire Pittsburgh Sleep Quality Index
Measured: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported chronotype
Self-reported chronotype as assessed from the Munich Chronotype Questionnaire
Measured: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported overall health and wellbeing
Self-reported overall health and wellbeing as assessed from the questionnaire Self-reported health (SF-36 health survey)
Measured: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Duration of eating period
Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app (mCC app)
Measured: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start31 Oct 2019
- Primary completion20 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Salk Institute for Biological Studies
- Responsible party
- Principal investigator, Iwona Swiatkiewicz, MD, PhD, FESC, Nicolaus Copernicus University
- Investigators
- Iwona Swiatkiewicz, MD, PhD, Principal investigator, Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328233
- Sponsor's protocol ID
- NCU CM IRB 107/2019
- Acronym
- TREMNIOS
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chaix A, Zarrinpar A, Miu P, Panda S. Time-restricted feeding is a preventative and therapeutic intervention against diverse nutritional challenges. Cell Metab. 2014 Dec 2;20(6):991-1005. doi: 10.1016/j.cmet.2014.11.001.
PubMed 25470547Gill S, Le HD, Melkani GC, Panda S. Time-restricted feeding attenuates age-related cardiac decline in Drosophila. Science. 2015 Mar 13;347(6227):1265-9. doi: 10.1126/science.1256682.
PubMed 25766238Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
PubMed 27885007Pot GK, Almoosawi S, Stephen AM. Meal irregularity and cardiometabolic consequences: results from observational and intervention studies. Proc Nutr Soc. 2016 Nov;75(4):475-486. doi: 10.1017/S0029665116000239. Epub 2016 Jun 22.
PubMed 27327128Gill S, Panda S. A Smartphone App Reveals Erratic Diurnal Eating Patterns in Humans that Can Be Modulated for Health Benefits. Cell Metab. 2015 Nov 3;22(5):789-98. doi: 10.1016/j.cmet.2015.09.005. Epub 2015 Sep 24.
PubMed 26411343Sulli G, Manoogian ENC, Taub PR, Panda S. Training the Circadian Clock, Clocking the Drugs, and Drugging the Clock to Prevent, Manage, and Treat Chronic Diseases. Trends Pharmacol Sci. 2018 Sep;39(9):812-827. doi: 10.1016/j.tips.2018.07.003. Epub 2018 Jul 27.
PubMed 30060890
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Time-Restricted Eating on Metabolic and Neuroendocrine Homeostasis, Inflammation and Oxidative Stress in Patients With Metabolic Syndrome: the TREMNIOS Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT04328233
- Acronym / sponsor ID
- TREMNIOS / NCU CM IRB 107/2019
- Keywords
- Time-Restricted Eating, Circadian Rhythm, Glucose Homeostasis, Fasting, Metabolic Syndrome, Overweight, Obesity, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Collaborators
- University of California, San Diego, Salk Institute for Biological Studies
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 31 Mar 2020 (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.
The main purpose of the clinical trial is to determine the health impact of a dietary intervention known as time-restricted eating (TRE) in patients with metabolic syndrome (defined as the presence of elevated fasting plasma glucose and two or more of the following criteria: increased waist circumference, elevated fasting plasma triglycerides, reduced high-density lipoprotein-cholesterol, elevated blood pressure) and self-reported dietary intake of ≥14 hours per day. Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (myCircadianClock (mCC) app). Glucose homeostasis (blood glucose levels will be monitored continuously for 2 weeks at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention using a continuous glucose monitor), and other metabolic, neuroendocrine, inflammatory and oxidative stress/antioxidant defense biomarkers, body weight and composition, blood pressure, heart rate, sleep and activity (using mCC app), personal sense of wellness and dietary timing (using health questionnaires) will be evaluated at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention.
Detailed description
Metabolic syndrome occurs in approximately 30% of adults and is associated with increased risk of cardiovascular disease and type 2 diabetes. Circadian rhythm disruption due to lifestyle including erratic eating patterns may lead to metabolic and neuroendocrine dysfunction, inflammation, oxidative stress, and cardiometabolic diseases. Maintaining a daily rhythm of eating and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and metabolism. Recent studies support the notion that restricting a period of food intake to 8-12 hours a day (time-restricted eating, TRE) can prevent and reverse obesity and metabolic dysfunction.
The main purpose of the clinical trial is to determine the health impact of TRE in patients with metabolic syndrome (defined as the presence of elevated fasting plasma glucose and two or more of the following criteria: increased waist circumference, elevated fasting plasma triglycerides, reduced high-density lipoprotein-cholesterol, elevated blood pressure) and self-reported dietary intake of ≥14 hours per day. Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (myCircadianClock (mCC) app, developed by the Salk Institute for Biological Studies). The participants will select a 10-h eating window that best suits their lifestyle. All food/beverages except water must be consumed within the time-interval. No further dietary restrictions will be applied. The participants will be provided with behavioral nutritional counseling by a dietician. Glucose homeostasis (blood glucose levels will be monitored continuously for 2 weeks at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention using a continuous glucose monitor), and other metabolic, neuroendocrine, inflammatory and oxidative stress/antioxidant defense biomarkers, body weight and composition, blood pressure, heart rate, sleep and activity (using mCC app), personal sense of wellness and dietary timing (using health questionnaires) will be evaluated at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention. The investigators will assess for compliance with TRE using mCC app.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted Eating | Experimental | Behavioral: Time-Restricted Eating |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Metabolic syndrome, defined as the presence of elevated fasting plasma glucose ≥ 100 mg/dL and two or more of the following criteria:
- Elevated waist circumference: ≥ 102 cm in men, ≥ 88 cm in women; Fasting plasma triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides); Reduced High-density lipoprotein (HDL)-cholesterol < 40 mg/dL in men, < 50 mg/dL in women (or drug treatment for reduced HDL-cholesterol); Elevated blood pressure, Systolic blood pressure ≥ 130 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg (or drug treatment for hypertension).
- BMI > 25
- Duration of eating period ≥ 14 hours/day.
- Own a Smartphone with Apple Operating System (OS) or Android OS.
Key exclusion criteria (16 listed)
- Diagnosis of diabetes.
- Pregnant or lactating women.
- Active smoking or illicit drug use or history of treatment for alcohol abuse.
- Shift work.
- Caregivers for dependent requiring nocturnal care.
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 EatingParticipants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (mCC app). The participants will select a 10-h eating window that best suits their lifestyle. All food/beverages except water must be consumed within the time-interval. No further dietary restrictions will be applied. The participants will be provided with behavioral nutritional counseling by a dietician. | Behavioural | Time-Restricted Eating |
Primary outcome
Change in body weight
Time frame: Baseline and after 14 weeks
Body weight (kg) as measured in fasted state on a digital scale
Change in fasting glucose concentration
Time frame: Baseline and after 14 weeks
Fasting plasma glucose concentration (mg/dl)
20 secondary outcomes
Body weight
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Body mass index
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Mean glucose
Time frame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Fasting glucose
Time frame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Lipids
Time frame: Changes from baseline. Measured in the blood in the fasted state at baseline, after 14 weeks, and after 26 weeks
Fat mass
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
HbA1c
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Metabolic and neuroendocrine biomarkers
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Inflammatory biomarkers
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Oxidative stress/antioxidant defense biomarkers
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Waist circumference
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Blood pressure
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Heart rate
Time frame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Energy intake
Time frame: Registered at baseline, after 14 weeks, and after 26 weeks
Timing of dietary intake
Time frame: Changes from baseline. Registered at baseline, after 14 weeks, and after 26 weeks
Self-reported sleepiness
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported sleep quality
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported chronotype
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported overall health and wellbeing
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Duration of eating period
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
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 1 Oct 2026.
- Background: PubMed 25470547Chaix A, Zarrinpar A, Miu P, Panda S. Time-restricted feeding is a preventative and therapeutic intervention against diverse nutritional challenges. Cell Metab. 2014 Dec 2;20(6):991-1005. doi: 10.1016/j.cmet.2014.11.001.
- Background: PubMed 25766238Gill S, Le HD, Melkani GC, Panda S. Time-restricted feeding attenuates age-related cardiac decline in Drosophila. Science. 2015 Mar 13;347(6227):1265-9. doi: 10.1126/science.1256682.
- Background: PubMed 27885007Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
- Background: PubMed 27327128Pot GK, Almoosawi S, Stephen AM. Meal irregularity and cardiometabolic consequences: results from observational and intervention studies. Proc Nutr Soc. 2016 Nov;75(4):475-486. doi: 10.1017/S0029665116000239. Epub 2016 Jun 22.
- Background: PubMed 26411343Gill S, Panda S. A Smartphone App Reveals Erratic Diurnal Eating Patterns in Humans that Can Be Modulated for Health Benefits. Cell Metab. 2015 Nov 3;22(5):789-98. doi: 10.1016/j.cmet.2015.09.005. Epub 2015 Sep 24.
- Background: PubMed 30060890Sulli G, Manoogian ENC, Taub PR, Panda S. Training the Circadian Clock, Clocking the Drugs, and Drugging the Clock to Prevent, Manage, and Treat Chronic Diseases. Trends Pharmacol Sci. 2018 Sep;39(9):812-827. doi: 10.1016/j.tips.2018.07.003. Epub 2018 Jul 27.
- Individual participant dataSharing planned: No
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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.
Iwona Swiatkiewicz, MD, PhD principal investigator
Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-Restricted Eating in people with Metabolic Syndrome and Overweight or Obesity, run by Nicolaus Copernicus University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Change in body weight (time frame: Baseline and after 14 weeks). 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 NCT04328233, which also lists 6 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 1 Oct 2026.