search
Back to results

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

Primary Purpose

Metabolic Syndrome, Overweight or Obesity, PreDiabetes

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Time-Restricted Eating
Sponsored by
Nicolaus Copernicus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Time-Restricted Eating, Circadian Rhythm, Glucose Homeostasis, Fasting, Metabolic Syndrome, Overweight, Obesity, PreDiabetes, Weight Loss, Metabolic Homeostasis, Neuroendocrine Biomarkers, Inflammation, Oxidative Stress

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nicolaus Copernicus University, Collegium Medicum BydgoszczRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Time-Restricted Eating

Arm Description

Outcomes

Primary Outcome Measures

Change in body weight
Body weight (kg) as measured in fasted state on a digital scale
Change in fasting glucose concentration
Fasting plasma glucose concentration (mg/dl)

Secondary Outcome Measures

Body weight
Body weight (kg) as measured in fasted state on a digital scale
Body mass index
Body mass index (kg/m^2) as calculated from body weight (kg) and height (m)
Mean glucose
Glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days 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
Lipids
Fasting blood concentrations of lipids: total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Fat mass
Fat mass percentage (%) as measured by body composition analyzer (using bioelectric impendence technology)
HbA1c
HbA1c (%) assessed from blood samples
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
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
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
Waist circumference
Waist circumference (cm) as measured using tape measure
Blood pressure
Systolic and diastolic blood pressure (mmHg) measured under resting and fasting conditions
Heart rate
Heart rate (bpm) measured under resting conditions during measurements of blood pressure
Energy intake
Energy intake (kcal/day) assessed from diet records
Timing of dietary intake
Timing of dietary intake (hh:mm) assessed from diet records and from the chrono-nutrition questionnaire
Self-reported sleepiness
Self-reported sleepiness as assessed from the questionnaire the Epworth Sleepiness Scale
Self-reported sleep quality
Self-reported sleep quality as assessed from the questionnaire Pittsburgh Sleep Quality Index
Self-reported chronotype
Self-reported chronotype as assessed from the Munich Chronotype Questionnaire
Self-reported overall health and wellbeing
Self-reported overall health and wellbeing as assessed from the questionnaire Self-reported health (SF-36 health survey)
Duration of eating period
Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app (mCC app)

Full Information

First Posted
March 27, 2020
Last Updated
March 31, 2020
Sponsor
Nicolaus Copernicus University
Collaborators
Salk Institute for Biological Studies, University of California, San Diego, Center for Obesity and Metabolic Disorders Treatment Bydgoszcz
search

1. Study Identification

Unique Protocol Identification Number
NCT04328233
Brief Title
Impact of Time-Restricted Eating on Metabolic and Neuroendocrine Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome
Acronym
TREMNIOS
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nicolaus Copernicus University
Collaborators
Salk Institute for Biological Studies, University of California, San Diego, Center for Obesity and Metabolic Disorders Treatment Bydgoszcz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-Restricted Eating
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Time-Restricted Eating
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight
Description
Body weight (kg) as measured in fasted state on a digital scale
Time Frame
Baseline and after 14 weeks
Title
Change in fasting glucose concentration
Description
Fasting plasma glucose concentration (mg/dl)
Time Frame
Baseline and after 14 weeks
Secondary Outcome Measure Information:
Title
Body weight
Description
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
Title
Body mass index
Description
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
Title
Mean glucose
Description
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
Title
Fasting glucose
Description
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
Title
Lipids
Description
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
Title
Fat mass
Description
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
Title
HbA1c
Description
HbA1c (%) assessed from blood samples
Time Frame
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Title
Metabolic and neuroendocrine biomarkers
Description
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
Title
Inflammatory biomarkers
Description
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
Title
Oxidative stress/antioxidant defense biomarkers
Description
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
Title
Waist circumference
Description
Waist circumference (cm) as measured using tape measure
Time Frame
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Title
Blood pressure
Description
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
Title
Heart rate
Description
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
Title
Energy intake
Description
Energy intake (kcal/day) assessed from diet records
Time Frame
Registered at baseline, after 14 weeks, and after 26 weeks
Title
Timing of dietary intake
Description
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
Title
Self-reported sleepiness
Description
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
Title
Self-reported sleep quality
Description
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
Title
Self-reported chronotype
Description
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
Title
Self-reported overall health and wellbeing
Description
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
Title
Duration of eating period
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celestyna Mila-Kierzenkowska, PhD
Phone
48 601 651 843
Email
celestyna@o2.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Jaroslaw Nuszkiewicz, MSc
Phone
48 507 143 411
Email
jnuszkiewicz@cm.umk.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iwona Swiatkiewicz, MD, PhD
Organizational Affiliation
Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
City
Bydgoszcz
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celestyna Mila-Kierzenkowska, PhD
Phone
48 601 651 843
Email
celestyna@o2.pl
First Name & Middle Initial & Last Name & Degree
Jaroslaw Nuszkiewicz, MSc
Phone
48 507 143 411
Email
jnuszkiewicz@cm.umk.pl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25470547
Citation
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.
Results Reference
background
PubMed Identifier
25766238
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.
Results Reference
background
PubMed Identifier
27885007
Citation
Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
Results Reference
background
PubMed Identifier
27327128
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.
Results Reference
background
PubMed Identifier
26411343
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.
Results Reference
background
PubMed Identifier
30060890
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs