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

Sponsor

Nicolaus Copernicus University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04328233

Collaborator

Salk Institute for Biological Studies (Other), University of California, San Diego (Other), Center for Obesity and Metabolic Disorders Treatment Bydgoszcz (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Overweight or Obesity PreDiabetes Weight Loss Quality of Life	Behavioral: Time-Restricted Eating	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Impact of Time-Restricted Eating on Metabolic and Neuroendocrine Homeostasis, Inflammation and Oxidative Stress in Patients With Metabolic Syndrome: the TREMNIOS Pilot Clinical Trial

Actual Study Start Date :

Oct 31, 2019

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Time-Restricted Eating	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Time-Restricted Eating

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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)
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
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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

BMI > 25
Duration of eating period ≥ 14 hours/day.
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.