Status:
COMPLETED
Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Trial
Lead Sponsor:
University of Basel
Collaborating Sponsors:
University of Lausanne
Technical University of Munich
Conditions:
Overweight and Obesity
Dyslipidemias
Eligibility:
All Genders
40-60 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the effects of an 8-week supervised high-intensity interval training (HIIT) program (vs. physical activity recommendations according to current guidelines) on a ...
Detailed Description
Cardiometabolic diseases (CMD) account for about half of all deaths from non-communicable diseases and are responsible for about one-third of all deaths worldwide. To combat the growing burden of CMD ...
Eligibility Criteria
Inclusion
- female or male sex,
- aged between 40 and 60 years,
- body mass index between 25.0 and 34.9 kg/m2,
- sedentary lifestyle, defined as not meeting the WHO guidelines on PA, i.e., at least 150 minutes of moderate-intensity aerobic PA per week as well as muscle-strengthening activities on two or more days per week,
- medical clearance for HIIT by a study physician (including vital sign evaluation, clinical examination, resting and exercise ECG),
- informed consent as documented by signature.
Exclusion
- known pregnancy or breastfeeding,
- any current exercise-limiting musculoskeletal conditions of the lower limbs,
- any known current or chronic conditions limiting exhaustive exercise,
- known diabetes mellitus of any type,
- dyslipidaemia, if pharmaceutically treated,
- arterial hypertension ≥160/100 mmHg, pharmaceutically treated or not,
- any other known cardiovascular disease,
- known NASH,
- known macular degeneration, glaucoma, or high intraocular pressure (≥20 mm Hg),
- particular diet (vegetarian, vegan, lactose-free, gluten-free, or FODMAP-low diet (ferment-able oligosaccharides, disaccharides, monosaccharides, and polyols),
- intake of glucagon-like peptide-1 analogues, orlistat or any weight-loss drug,
- inability to follow the procedures of the study, e.g., due to linguistic or cognitive problems,
- concomitant involvement in another interventional trial or participation in another interventional trial in the last four weeks.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06024291
Start Date
September 15 2023
End Date
January 15 2025
Last Update
May 15 2025
Active Locations (1)
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1
Department of Sport, Exercise and Health, University of Basel
Basel, Canton of Basel-City, Switzerland, 4052