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Einfluss zeitlich begrenzter Nahrungsaufnahme auf die metabolische und neuroendokrine Homöostase, Entzündung und oxidativen Stress beim metabolischen Syndrom (TREMNIOS)

28. September 2026 aktualisiert von: Iwona Swiatkiewicz, MD, PhD, FESC, Nicolaus Copernicus University

Einfluss zeitlich begrenzter Nahrungsaufnahme auf die metabolische und neuroendokrine Homöostase, Entzündung und oxidativen Stress bei Patienten mit metabolischem Syndrom: die klinische Pilotstudie TREMNIOS

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

27

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Zeitlich begrenztes Essen
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in body weight
Zeitfenster: 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
Zeitfenster: Baseline and after 14 weeks

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Body weight
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Nicolaus Copernicus University

Mitarbeiter

University of California, San Diego
Salk Institute for Biological Studies

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

31. Oktober 2019

Primärer Abschluss (Tatsächlich)

20. September 2023

Studienabschluss (Tatsächlich)

30. Dezember 2023

Studienanmeldedaten

Zuerst eingereicht

27. März 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. März 2020

Zuerst gepostet (Tatsächlich)

31. März 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NCU CM IRB 107/2019

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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