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Impact van tijdgebonden eten op metabole en neuro-endocriene homeostase, ontsteking en oxidatieve stress bij het metabool syndroom (TREMNIOS)

28 september 2026 bijgewerkt door: Iwona Swiatkiewicz, MD, PhD, FESC, Nicolaus Copernicus University

Impact van tijdgebonden eten op metabole en neuro-endocriene homeostase, ontsteking en oxidatieve stress bij patiënten met het metabool syndroom: de 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

27

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Polen
      • Bydgoszcz, Polen
        • Nicolaus Copernicus University, Collegium Medicum Bydgoszcz

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. 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).

  2. BMI > 25

  3. Duration of eating period ≥ 14 hours/day.

  4. Own a Smartphone with Apple Operating System (OS) or Android OS.

Exclusion Criteria:

  1. Diagnosis of diabetes.
  2. Pregnant or lactating women.
  3. Active smoking or illicit drug use or history of treatment for alcohol abuse.
  4. Shift work.
  5. Caregivers for dependent requiring nocturnal care.
  6. Planned travel over time zones during the study period.
  7. 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.
  8. Uncontrolled medical conditions due to rheumatologic, hematologic, oncologic, infectious, gastrointestinal, psychiatric, nephrological, or endocrine diseases.
  9. Known history of an eating disorder.
  10. Currently enrolled in a weight-loss or weight-management program.
  11. Special or prescribed diet for other reasons (e.g. Celiac disease).
  12. Current treatment with antidepressants, medications affecting appetite, or immunosuppression.
  13. History of bariatric surgery.
  14. A score of > 16 on the Epworth Sleepiness Scale.
  15. Depression determined by the Beck Depression Inventory.
  16. Failure to use the smartphone app for documentation during a 2-week baseline period.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Tijdgebonden eten
Gedragsmatig: Time-Restricted Eating

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in body weight
Tijdsspanne: Baseline and after 14 weeks

Body weight (kg) as measured in fasted state on a digital scale
Baseline and after 14 weeks
Change in fasting glucose concentration
Tijdsspanne: Baseline and after 14 weeks

Fasting plasma glucose concentration (mg/dl)
Baseline and after 14 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body weight
Tijdsspanne: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Body weight (kg) as measured in fasted state on a digital scale
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Body mass index
Tijdsspanne: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Body mass index (kg/m^2) as calculated from body weight (kg) and height (m)
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Mean glucose
Tijdsspanne: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks

Glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks
Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Fasting glucose
Tijdsspanne: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks

Fasting glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks
Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Lipids
Tijdsspanne: Changes from baseline. Measured in the blood in the fasted state at baseline, after 14 weeks, and after 26 weeks

Fasting blood concentrations of lipids: total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Changes from baseline. Measured in the blood in the fasted state at baseline, after 14 weeks, and after 26 weeks
Fat mass
Tijdsspanne: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Fat mass percentage (%) as measured by body composition analyzer (using bioelectric impendence technology)
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
HbA1c
Tijdsspanne: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

HbA1c (%) assessed from blood samples
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Metabolic and neuroendocrine biomarkers
Tijdsspanne: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

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
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Inflammatory biomarkers
Tijdsspanne: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

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
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Oxidative stress/antioxidant defense biomarkers
Tijdsspanne: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

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
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Waist circumference
Tijdsspanne: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Waist circumference (cm) as measured using tape measure
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Blood pressure
Tijdsspanne: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Systolic and diastolic blood pressure (mmHg) measured under resting and fasting conditions
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Heart rate
Tijdsspanne: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks

Heart rate (bpm) measured under resting conditions during measurements of blood pressure
Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Energy intake
Tijdsspanne: Registered at baseline, after 14 weeks, and after 26 weeks

Energy intake (kcal/day) assessed from diet records
Registered at baseline, after 14 weeks, and after 26 weeks
Timing of dietary intake
Tijdsspanne: Changes from baseline. Registered at baseline, after 14 weeks, and after 26 weeks

Timing of dietary intake (hh:mm) assessed from diet records and from the chrono-nutrition questionnaire
Changes from baseline. Registered at baseline, after 14 weeks, and after 26 weeks
Self-reported sleepiness
Tijdsspanne: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Self-reported sleepiness as assessed from the questionnaire the Epworth Sleepiness Scale
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported sleep quality
Tijdsspanne: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Self-reported sleep quality as assessed from the questionnaire Pittsburgh Sleep Quality Index
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported chronotype
Tijdsspanne: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Self-reported chronotype as assessed from the Munich Chronotype Questionnaire
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported overall health and wellbeing
Tijdsspanne: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Self-reported overall health and wellbeing as assessed from the questionnaire Self-reported health (SF-36 health survey)
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Duration of eating period
Tijdsspanne: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app (mCC app)
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nicolaus Copernicus University

Medewerkers

University of California, San Diego
Salk Institute for Biological Studies

Onderzoekers

  • Hoofdonderzoeker: Iwona Swiatkiewicz, MD, PhD, Nicolaus Copernicus University, Collegium Medicum Bydgoszcz

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 oktober 2019

Primaire voltooiing (Werkelijk)

20 september 2023

Studie voltooiing (Werkelijk)

30 december 2023

Studieregistratiedata

Eerst ingediend

27 maart 2020

Eerst ingediend dat voldeed aan de QC-criteria

27 maart 2020

Eerst geplaatst (Werkelijk)

31 maart 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

28 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCU CM IRB 107/2019

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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