NCT04328233Completed
Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome
Impact of Time-Restricted Eating on Metabolic and Neuroendocrine Homeostasis, Inflammation and Oxidative Stress in Patients With Metabolic Syndrome: the TREMNIOS Pilot Clinical Trial
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 27 Mar 2020
- Start date
- 31 Oct 2019
- Primary completion date
- 20 Sept 2023
- Lead sponsor
- Nicolaus Copernicus University
- Diseases
- Obesity
- NCT number
- NCT04328233
What you commit to
- Study type: Interventional
- Participants enrolled: 27
- From 31 Oct 2019 to the primary completion date, 20 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with antidepressants, medications affecting appetite, or immunosuppression.
Other illness
- Diagnosis of diabetes.
- Active smoking or illicit drug use or history of treatment for alcohol abuse.
- 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.
- Special or prescribed diet for other reasons (e.g. Celiac disease).
- History of bariatric surgery.
- Failure to use the smartphone app for documentation during a 2-week baseline period.
Other
- Pregnant or lactating women.
- Shift work.
- Caregivers for dependent requiring nocturnal care.
- Planned travel over time zones during the study period.
- Currently enrolled in a weight-loss or weight-management program.
- A score of \> 16 on the Epworth Sleepiness Scale.
- Depression determined by the Beck Depression Inventory.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nicolaus Copernicus University, Collegium Medicum Bydgoszcz Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.