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Indvirkning af tidsbegrænset spisning på metabolisk og neuroendokrin homeostase, inflammation og oxidativ stress i metabolisk syndrom (TREMNIOS)

28. september 2026 opdateret af: Iwona Swiatkiewicz, MD, PhD, FESC, Nicolaus Copernicus University

Indvirkning af tidsbegrænset spisning på metabolisk og neuroendokrin homøostase, inflammation og oxidativ stress hos patienter med metabolisk syndrom: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

27

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tidsbegrænset spisning

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in body weight
Tidsramme: 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
Tidsramme: Baseline and after 14 weeks

Fasting plasma glucose concentration (mg/dl)

Baseline and after 14 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body weight
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. oktober 2019

Primær færdiggørelse (Faktiske)

20. september 2023

Studieafslutning (Faktiske)

30. december 2023

Datoer for studieregistrering

Først indsendt

27. marts 2020

Først indsendt, der opfyldte QC-kriterier

27. marts 2020

Først opslået (Faktiske)

31. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NCU CM IRB 107/2019

Plan for individuelle deltagerdata (IPD)

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