Metabolic Syndrome, Overweight or Obesity, PreDiabetes, Quality of Life, Weight Loss
Conditions
Keywords
Time-Restricted Eating, Circadian Rhythm, Glucose Homeostasis, Fasting, Metabolic Syndrome, Overweight, Obesity, PreDiabetes, Weight Loss, Metabolic Homeostasis, Neuroendocrine Biomarkers, Inflammation, Oxidative Stress
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTime-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.
Sponsors
Salk Institute for Biological Studies
University of California, San Diego
Center for Obesity and Metabolic Disorders Treatment Bydgoszcz
Nicolaus Copernicus University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline and after 14 weeks | Body weight (kg) as measured in fasted state on a digital scale |
| Change in fasting glucose concentration | Baseline and after 14 weeks | Fasting plasma glucose concentration (mg/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean glucose | 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 |
| Fasting glucose | 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 |
| Lipids | 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) |
| Fat mass | 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) |
| HbA1c | Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks | HbA1c (%) assessed from blood samples |
| Metabolic and neuroendocrine biomarkers | 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 |
| Inflammatory biomarkers | 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 |
| Oxidative stress/antioxidant defense biomarkers | 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 |
| Waist circumference | Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks | Waist circumference (cm) as measured using tape measure |
| Body weight | 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 |
| Heart rate | 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 |
| Energy intake | Registered at baseline, after 14 weeks, and after 26 weeks | Energy intake (kcal/day) assessed from diet records |
| Timing of dietary intake | 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 |
| Self-reported sleepiness | 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 |
| Self-reported sleep quality | 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 |
| Self-reported chronotype | Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks | Self-reported chronotype as assessed from the Munich Chronotype Questionnaire |
| Self-reported overall health and wellbeing | 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) |
| Duration of eating period | 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) |
| Blood pressure | 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 |
| Body mass index | 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) |
Countries
Poland
Outcome results
None listed