Impact de l'alimentation limitée dans le temps sur l'homéostasie métabolique et neuroendocrinienne, l'inflammation et le stress oxydatif dans le syndrome métabolique (TREMNIOS)
Impact de l'alimentation à durée limitée sur l'homéostasie métabolique et neuroendocrinienne, l'inflammation et le stress oxydatif chez les patients atteints du syndrome métabolique : l'essai clinique pilote 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Bydgoszcz, Pologne
- Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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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).
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BMI > 25
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Duration of eating period ≥ 14 hours/day.
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Own a Smartphone with Apple Operating System (OS) or Android OS.
Exclusion Criteria:
- 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.
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Manger limité dans le temps
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in body weight
Délai: Baseline and after 14 weeks
|
Body weight (kg) as measured in fasted state on a digital scale |
Baseline and after 14 weeks
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Change in fasting glucose concentration
Délai: Baseline and after 14 weeks
|
Fasting plasma glucose concentration (mg/dl) |
Baseline and after 14 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body weight
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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Inflammatory biomarkers
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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Timing of dietary intake
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Iwona Swiatkiewicz, MD, PhD, Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
Publications et liens utiles
Publications générales
- Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
- 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.
- Gill 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.
- Pot 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.
- Gill 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.
- Sulli 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Processus pathologiques
- Troubles nutritionnels
- Maladies métaboliques
- Suralimentation
- Poids
- Changements de poids corporel
- Troubles du métabolisme du glucose
- Diabète sucré
- Résistance à l'insuline
- Hyperinsulinisme
- Conditions pathologiques, signes et symptômes
- Comportement
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Comportement alimentaire
- En surpoids
- Obésité
- Perte de poids
- Syndrome métabolique
- Inflammation
- État prédiabétique
- Jeûne
- Jeûne intermittent
Autres numéros d'identification d'étude
- NCU CM IRB 107/2019
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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