Clinical trial NCT04328233: Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Overweight or Obesity
PreDiabetes
Weight Loss
Quality of Life
Keywords: Time-Restricted Eating
Circadian Rhythm
Glucose Homeostasis
Fasting
Metabolic Syndrome
Overweight
Obesity
PreDiabetes
Weight Loss
Metabolic Homeostasis
Neuroendocrine Biomarkers
Inflammation
Oxidative Stress
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
Collaborators: name: Salk Institute for Biological Studies
name: University of California, San Diego
name: Center for Obesity and Metabolic Disorders Treatment Bydgoszcz
First posted: 2020-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline and after 14 weeks
measure: Change in fasting glucose concentration
timeFrame: Baseline and after 14 weeks
Secondary outcomes:
measure: Body weight
timeFrame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
measure: Body mass index
timeFrame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
measure: Mean glucose
timeFrame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
measure: Fasting glucose
timeFrame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
measure: Lipids
timeFrame: Changes from baseline. Measured in the blood in the fasted state at baseline, after 14 weeks, and after 26 weeks
measure: Fat mass
timeFrame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
measure: HbA1c
timeFrame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
measure: Metabolic and neuroendocrine biomarkers
timeFrame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
measure: Inflammatory biomarkers
timeFrame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
measure: Oxidative stress/antioxidant defense biomarkers
timeFrame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
measure: Waist circumference
timeFrame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
measure: Blood pressure
timeFrame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
measure: Heart rate
timeFrame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
measure: Energy intake
timeFrame: Registered at baseline, after 14 weeks, and after 26 weeks
measure: Timing of dietary intake
timeFrame: Changes from baseline. Registered at baseline, after 14 weeks, and after 26 weeks
measure: Self-reported sleepiness
timeFrame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
measure: Self-reported sleep quality
timeFrame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
measure: Self-reported chronotype
timeFrame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
measure: Self-reported overall health and wellbeing
timeFrame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
measure: Duration of eating period
timeFrame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
Study officials:
affiliation: Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
name: Iwona Swiatkiewicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
citation: 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.
citation: 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.
citation: 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.