Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome

Nicolaus Copernicus University30 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in body weight

Body weight (kg) as measured in fasted state on a digital scale

Time frame: Baseline and after 14 weeks

Change in fasting glucose concentration

Fasting plasma glucose concentration (mg/dl)

Time frame: Baseline and after 14 weeks

Secondary Outcomes

Body weight

Body weight (kg) as measured in fasted state on a digital scale

Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Body mass index

Body mass index (kg/m\^2) as calculated from body weight (kg) and height (m)

Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Mean glucose

Glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks

Time frame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks

Fasting glucose

Fasting glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks

Time frame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks

Lipids

Fasting blood concentrations of lipids: total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)

Time frame: Changes from baseline. Measured in the blood in the fasted state at baseline, after 14 weeks, and after 26 weeks

Fat mass

Fat mass percentage (%) as measured by body composition analyzer (using bioelectric impendence technology)

Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

HbA1c

HbA1c (%) assessed from blood samples

Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Metabolic and neuroendocrine biomarkers

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

Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Inflammatory biomarkers

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

Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Oxidative stress/antioxidant defense biomarkers

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

Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Waist circumference

Waist circumference (cm) as measured using tape measure

Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Blood pressure

Systolic and diastolic blood pressure (mmHg) measured under resting and fasting conditions

Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks

Heart rate

Heart rate (bpm) measured under resting conditions during measurements of blood pressure

Time frame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks

Energy intake

Energy intake (kcal/day) assessed from diet records

Time frame: Registered at baseline, after 14 weeks, and after 26 weeks

Timing of dietary intake

Timing of dietary intake (hh:mm) assessed from diet records and from the chrono-nutrition questionnaire

Time frame: Changes from baseline. Registered at baseline, after 14 weeks, and after 26 weeks

Self-reported sleepiness

Self-reported sleepiness as assessed from the questionnaire the Epworth Sleepiness Scale

Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Self-reported sleep quality

Self-reported sleep quality as assessed from the questionnaire Pittsburgh Sleep Quality Index

Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Self-reported chronotype

Self-reported chronotype as assessed from the Munich Chronotype Questionnaire

Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Self-reported overall health and wellbeing

Self-reported overall health and wellbeing as assessed from the questionnaire Self-reported health (SF-36 health survey)

Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Duration of eating period

Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app (mCC app)

Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks

Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes