Status:
ACTIVE_NOT_RECRUITING
Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome
Lead Sponsor:
Nicolaus Copernicus University
Collaborating Sponsors:
Salk Institute for Biological Studies
University of California, San Diego
Conditions:
Metabolic Syndrome
Overweight or Obesity
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 err...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04328233
Start Date
October 31 2019
End Date
December 31 2024
Last Update
January 9 2024
Active Locations (1)
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1
Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
Bydgoszcz, Poland