Impacto de la Alimentación Restringida en el Tiempo en la Homeostasis Metabólica y Neuroendocrina, la Inflamación y el Estrés Oxidativo en el Síndrome Metabólico (TREMNIOS)
Impacto de la alimentación restringida en el tiempo sobre la homeostasis metabólica y neuroendocrina, la inflamación y el estrés oxidativo en pacientes con síndrome metabólico: el ensayo clínico piloto 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Bydgoszcz, Polonia
- Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Alimentación restringida en el tiempo
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in body weight
Periodo de tiempo: 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
Periodo de tiempo: Baseline and after 14 weeks
|
Fasting plasma glucose concentration (mg/dl) |
Baseline and after 14 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body weight
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Waist circumference
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Self-reported overall health and wellbeing
Periodo de tiempo: 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
|
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Duration of eating period
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Iwona Swiatkiewicz, MD, PhD, Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Cambios en el peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Resistencia a la insulina
- Hiperinsulinismo
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Comportamiento de alimentación
- Exceso de peso
- Obesidad
- Pérdida de peso
- Síndrome metabólico
- Inflamación
- Estado prediabético
- Ayuno
- Ayuno intermitente
Otros números de identificación del estudio
- NCU CM IRB 107/2019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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