Investigating the Circulating Sphingolipidome Response to a Single High-intensity Interval Training Session
SphingoHIIT
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
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to examine the response of a comprehensive panel of circulating sphingolipids to a single high-intensity interval training (HIIT) session in healthy individuals in their twenties.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2023
CompletedMay 15, 2025
May 1, 2025
4 months
May 19, 2022
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentration of circulating Cer16:0, Cer18:0, Cer24:0 and Cer24:1
Quantifying the changes in serum level in the four sphingolipid species included in the ceramide-based scores (Cer16:0, Cer18:0, Cer24:0 and Cer24:1) following a single HIIT session.
72 hours
Secondary Outcomes (1)
Concentration of the resting circulating sphingolipid species to be acquired
72 hours
Study Arms (2)
HIIT group
EXPERIMENTALThe HIIT session will be conducted on a bicycle ergometer and consist of a 3-minute warm-up, followed by 4x4-minute intervals performed at 85-95% of the individually determined maximum heart rate, interspersed with 3-minute active recovery phases at a light effort). The HIIT session will be followed by a 2-minute cool-down phase.
Control group
NO INTERVENTIONThe control group will follow the same procedure except for the HIIT session, which will be replaced by a 30-minute physical rest in a sitting position. The participants will be allowed to read a book or work on their computer/phone.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Basellead
- University of Lausannecollaborator
Study Sites (1)
Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel
Basel, Canton of Basel-City, 4052, Switzerland
Related Publications (5)
Choi RH, Tatum SM, Symons JD, Summers SA, Holland WL. Ceramides and other sphingolipids as drivers of cardiovascular disease. Nat Rev Cardiol. 2021 Oct;18(10):701-711. doi: 10.1038/s41569-021-00536-1. Epub 2021 Mar 26.
PMID: 33772258BACKGROUNDLaaksonen R, Ekroos K, Sysi-Aho M, Hilvo M, Vihervaara T, Kauhanen D, Suoniemi M, Hurme R, Marz W, Scharnagl H, Stojakovic T, Vlachopoulou E, Lokki ML, Nieminen MS, Klingenberg R, Matter CM, Hornemann T, Juni P, Rodondi N, Raber L, Windecker S, Gencer B, Pedersen ER, Tell GS, Nygard O, Mach F, Sinisalo J, Luscher TF. Plasma ceramides predict cardiovascular death in patients with stable coronary artery disease and acute coronary syndromes beyond LDL-cholesterol. Eur Heart J. 2016 Jul 1;37(25):1967-76. doi: 10.1093/eurheartj/ehw148. Epub 2016 Apr 28.
PMID: 27125947BACKGROUNDTippetts TS, Holland WL, Summers SA. Cholesterol - the devil you know; ceramide - the devil you don't. Trends Pharmacol Sci. 2021 Dec;42(12):1082-1095. doi: 10.1016/j.tips.2021.10.001. Epub 2021 Nov 5.
PMID: 34750017BACKGROUNDCarrard J, Gallart-Ayala H, Weber N, Colledge F, Streese L, Hanssen H, Schmied C, Ivanisevic J, Schmidt-Trucksass A. How Ceramides Orchestrate Cardiometabolic Health-An Ode to Physically Active Living. Metabolites. 2021 Sep 30;11(10):675. doi: 10.3390/metabo11100675.
PMID: 34677390BACKGROUNDCarrard J, Angst T, Weber N, Bienvenue J, Infanger D, Streese L, Hinrichs T, Croci I, Schmied C, Gallart-Ayala H, Hochsmann C, Koehler K, Hanssen H, Ivanisevic J, Schmidt-Trucksass A. Investigating the circulating sphingolipidome response to a single high-intensity interval training session within healthy females and males in their twenties (SphingoHIIT): Protocol for a randomised controlled trial. F1000Res. 2023 Aug 18;11:1565. doi: 10.12688/f1000research.128978.3. eCollection 2022.
PMID: 37533665DERIVED
Study Officials
- STUDY CHAIR
Arno Schmidt-Trucksäss, Prof
Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants and investigators (except for the principal investigator) will also discover on the day of the HIIT intervention to which group they are allocated (HIIT vs. no exercise intervention). This information will be enclosed in a sealed envelope by the principal investigator.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral researcher, Principal investigator
Study Record Dates
First Submitted
May 19, 2022
First Posted
May 25, 2022
Study Start
September 1, 2022
Primary Completion
January 4, 2023
Study Completion
January 4, 2023
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share