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

NCT04328233 | Unknown

• 1 other identifier: NCU CM IRB 107/2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Change in body weight

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

  Baseline and after 14 weeks

• Change in fasting glucose concentration

  Fasting plasma glucose concentration (mg/dl)

  Baseline and after 14 weeks

Secondary Outcomes (20)

• Body weight

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

• Body mass index

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

• Mean glucose

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

• Fasting glucose

  Changes from baseline. Measured 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

Study Arms (1)

Time-Restricted Eating

EXPERIMENTAL

Behavioral: Time-Restricted Eating

Interventions

Time-Restricted Eating BEHAVIORAL

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.

Time-Restricted Eating

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicolaus Copernicus University: lead
• Salk Institute for Biological Studies: collaborator
• University of California, San Diego: collaborator
• Center for Obesity and Metabolic Disorders Treatment Bydgoszcz: collaborator

Study Sites (1)

Nicolaus Copernicus University, Collegium Medicum Bydgoszcz

Bydgoszcz, Poland

Location

Related Publications (6)

• 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.

  PMID: 25470547 BACKGROUND

• 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.

  PMID: 25766238 BACKGROUND

• Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.

  PMID: 27885007 BACKGROUND

• 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.

  PMID: 27327128 BACKGROUND

• 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.

  PMID: 26411343 BACKGROUND

• 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.

  PMID: 30060890 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Overweight; Obesity; Prediabetic State; Weight Loss; Intermittent Fasting; Fasting; Inflammation

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases; Body Weight Changes; Feeding Behavior; Behavior; Pathologic Processes

Study Officials

• Iwona Swiatkiewicz, MD, PhD

  Nicolaus Copernicus University, Collegium Medicum Bydgoszcz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: October 31, 2019
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)