The SphingoHIIT Study
Descrizione riassuntiva dello studio
There is increasing scientific evidence that certain sphingolipids, known as ceramides, predict cardiovascular risk better than traditionally used biomarkers. Mechanistically, ceramides promote the formation of foam cells, vascular inflammation, peripheral insulin resistance, and thus atherosclerosis. It is currently unclear whether and to what extent physical activity, a simple and cost-effective means, can reduce sphingolipid levels to optimize cardiometabolic health. The SphingoHIIT study aims to investigate how selected circulating sphingolipids respond to a single high-intensity interval training (HIIT). The hypothesis to be tested is that circulating sphingolipid levels are temporarily elevated after a single HIIT. This risk class A study lasts 11 days and includes 32 healthy participants aged between 20 and 29 years (50% women). Participants will be randomly assigned to the intervention group (n= 16) or the control group (n= 16). Using a cardiopulmonary exercise test, maximum oxygen uptake and maximum heart rate will be determined. Following this, a five-day washout phase will be observed. Participants will then self-collect capillary blood samples to determine the baseline sphingolipid levels. After three days of morning blood draws at home, participants will complete a single HIIT session. The HIIT will then be adjusted to the measured maximum load, ensuring the same intensity for all subjects. Dried blood samples will be taken at five additional specific time points (2 minutes, 15 minutes, 30 minutes, 60 minutes, and 24 hours) after the HIIT. To minimize the influence of diet, participants will be asked to consume only the provided pre-packaged meals starting one day before the first blood draw.
(BASEC)
Intervento studiato
High-intensity interval training on a cycle ergometer (3 min. warm-up, 4x 4 min. at 85-95% of maximum heart rate, with 3 min. of light cycling in between, 2 min. cool-down).
(BASEC)
Malattie studiate
Healthy young female and male participants aged between 20 and 29 years
(BASEC)
- Female or male sex, - Age between 20 and 29 years, - Body Mass Index (BMI) between 18.5 and 24.9 kg/m2, - Adherence to the World Health Organization (WHO) guidelines for physical activity, i.e., at least 150 to 300 minutes of moderate-intensity aerobic physical activity per week as well as muscle-strengthening activities on 2 or more days per week, - Clearance for physical activity according to the PAR-Q+ 2022, - Regular menstrual cycle, - Informed consent documented by signature. (BASEC)
Criteri di esclusione
- Women with known pregnancy, breastfeeding, or polycystic ovary syndrome - Current lower limb diseases that limit physical performance, - Acute or chronic diseases: e.g., active infectious diseases, previous or current malignant tumors, lung diseases, cardiometabolic diseases, gastrointestinal diseases, mental disorders, endocrine diseases, nephrological diseases, neurological diseases, - Current or past smoking, current or past substance use, - Excessive alcohol consumption in the last two weeks, defined as binge drinking (consumption of five or more drinks on a single occasion) or heavy drinking (consumption of 15 or more drinks per week), - Current or regular use of medications, including any form of hormonal contraception, - Diet: vegetarian, vegan, lactose-free and gluten-free, FODMAP-free - Inability to follow the study procedures, e.g., due to language or cognitive problems, - Simultaneous participation in another study or participation in another study in the last 4 weeks. (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
Prof Dr Arno Schmidt-Trucksäss, Departement für Sport, Bewegung und Gesundheit, Universität Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Justin Carrard
+41 61 207 47 57
justin.carrard@clutterunibas.chDepartement für Sport, Bewegung und Gesundheit, Universität Basel
(BASEC)
Informazioni generali
Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
(ICTRP)
Informazioni scientifiche
Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
13.05.2022
(BASEC)
ID di studio ICTRP
NCT05390866 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Investigating the Circulating Sphingolipidome Response to a Single High-intensity Interval Training Session (SphingoHIIT) (BASEC)
Titolo accademico
A Monocentric Randomised Controlled Trial to Investigate Changes in the Circulating Sphingolipidome Composition of Young and Healthy Individuals in Response to a Single Session of High-intensity Interval Training: the SphingoHIIT Study (ICTRP)
Titolo pubblico
Investigating the Circulating Sphingolipidome Response to a Single High-intensity Interval Training Session (ICTRP)
Malattie studiate
Physiological Response of Sphingolipids to a Single HIIT Session (ICTRP)
Intervento studiato
Other: HIIT (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Female or male sex,
- Aged between 20 and 29 years old,
- Body Mass Index (BMI) between 18.5 and 24.9 kg/m2,
- Meeting the World Health Organization (WHO) guidelines on physical activity, i.e. at
least 150-300 minutes of moderate-intensity aerobic physical activity per week as
well as muscle-strengthening activities on 2 or more days per week,
- Clearance for physical activity according to the 2022 Physical Activity Readiness
Questionnaire (PAR-Q+),
- Regular menstrual cycle,
- Informed consent as documented by signature.
Exclusion Criteria:
- Females with known pregnancy or breastfeeding,
- Females with known polycystic ovary syndrome (PCOS),
- Current exercise-limiting conditions of the lower limbs (e.g. tendinopathy,
fractures or other musculoskeletal pathologies),
- Known acute or chronic diseases: e.g. any active infectious diseases, any past or
current malignant tumours, any lung diseases (e.g. bronchial asthma), any
cardiometabolic diseases (e.g. arterial hypertension, diabetes, dyslipidaemia), any
gastrointestinal diseases (e.g. coeliac disease, Crohn's disease, ulcerative
colitis), any psychological disorders (e.g. depression, if medically diagnosed,
anorexia, bulimia), any endocrinological diseases (e.g. all types of diabetes
mellitus, hyper- or hypothyroidism), any nephrological diseases, any neurological
disorders,
- Current or past smoking, current or past psychoactive drug use (alcohol excluded
here, see below),
- Excessive alcohol consumption in the past two weeks, defined as either binge
drinking (consuming five or more drinks during a single occasion) or heavy drinking
(consuming 15 or more drinks per week),
- Any current or regular medication use, including any kind of hormonal contraception,
- Diet: vegetarian, vegan, lactose-free and gluten-free, FODMAP-free (fermentable
oligosaccharides, disaccharides, monosaccharides, and polyols),
- Inability to follow the procedures of the study, e.g. due to linguistic or cognitive
problems,
- Concomitant involvement in another trial or participation in another trial in the
last 4 weeks. (ICTRP)
non disponibile
Endpoint primari e secondari
Concentration of circulating Cer16:0, Cer18:0, Cer24:0 and Cer24:1 (ICTRP)
Concentration of the resting circulating sphingolipid species to be acquired (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Lausanne (ICTRP)
Contatti aggiuntivi
Arno Schmidt-Trucksss, Prof, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland (ICTRP)
ID secondari
EKNZ 2022-00513 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05390866 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile