The SphingoHIIT Study
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
- 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)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
Prof Dr Arno Schmidt-Trucksäss, Departement für Sport, Bewegung und Gesundheit, Universität Basel
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Justin Carrard
+41 61 207 47 57
justin.carrard@clutterunibas.chDepartement für Sport, Bewegung und Gesundheit, Universität Basel
(BASEC)
Informations générales
Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
(ICTRP)
Informations scientifiques
Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
13.05.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT05390866 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Investigating the Circulating Sphingolipidome Response to a Single High-intensity Interval Training Session (SphingoHIIT) (BASEC)
Titre académique
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)
Titre public
Investigating the Circulating Sphingolipidome Response to a Single High-intensity Interval Training Session (ICTRP)
Maladie en cours d'investigation
Physiological Response of Sphingolipids to a Single HIIT Session (ICTRP)
Intervention étudiée
Other: HIIT (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). (ICTRP)
Critères d'inclusion/exclusion
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)
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Critères d'évaluation principaux et secondaires
Concentration of circulating Cer16:0, Cer18:0, Cer24:0 and Cer24:1 (ICTRP)
Concentration of the resting circulating sphingolipid species to be acquired (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
University of Lausanne (ICTRP)
Contacts supplémentaires
Arno Schmidt-Trucksss, Prof, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland (ICTRP)
ID secondaires
EKNZ 2022-00513 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05390866 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible