Physiological Response of Sphingolipids to a Single HIIT SessionSphingoHIITNCT05390866
Investigating the Circulating Sphingolipidome Response to a Single High-intensity Interval Training Session
A study testing HIIT in people with Physiological Response of Sphingolipids to a Single HIIT Session, run by University of Basel at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Response of Sphingolipids to a Single HIIT Session
- What is being tested?
- HIIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2022to 4 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel
Basel, Canton of Basel-City, 4052
About this study
Official title: 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
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.
Read the detailed description
Growing scientific evidence shows that specific sphingolipids, known as ceramides, predict cardiovascular risk beyond traditionally used biomarkers such as lipoproteins and triglycerides. Mechanistically, ceramides have been shown to promote foam cell formation, vascular inflammation, peripheral insulin resistance, and ultimately atherosclerosis. Currently, however, it remains unclear if and how physical activity, a simple, low-cost, and patient-empowering mean to optimise cardiometabolic health, can mitigate sphingolipid levels. The SphingoHIIT study aims to assess how certain circulating sphingolipid species respond to a single session of high-intensity interval training (HIIT). We hypothesise that circulating sphingolipid levels will be temporarily increased following a single HIIT session. This risk category A study will last 11 days and include 32 healthy participants aged between 20 and 29 years (50% of females). Participants will be randomly allocated either to the intervention group (n= 16) or the control group (n= 16). Blocked randomisation will be used to reduce bias and achieve balance in the allocation of participants to both groups, as commonly done when the sample size is small. Following an assessment of inclusion and exclusion criteria, a maximal cardiopulmonary exercise testing will be performed to determine peak oxygen uptake and peak heart rate. A washout period of five days will then be carried out before participants start to self-sample fasted dried blood spots to determine baseline levels of sphingolipids. After three days of sampling, participants will undergo a single HIIT session. Dried blood spots will be collected at five additional fixed time points (2min, 15min, 30min, 60min, and 24h) following the HIIT session. To minimise the dietary influence, participants will be asked to solely consume the provided individualised, pre-packaged meals starting one day before the first dried blood sampling.
Additionally, for the duration of the whole study, participants will wear a wrist accelerometer to track their physical activity. The SphingoHIIT study is expected to provide novel knowledge regarding the effect of an acute bout of physical exercise on sphingolipid levels. The results of this study will be published in a peer-reviewed journal and will be presented at scientific conferences.
- Being tested
- HIIT
- Keywords
- Metabolomics, Lipidomics, High-intensity interval training, Ceramides, Sphingolipids, Cardiometabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
A single HIIT on a bicycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| HIIT group | Experimental | The 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. Receives: Other: HIIT |
| Control group | No intervention | The 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (1)
Concentration of the resting circulating sphingolipid species to be acquired
Quantifying the changes in serum level in the resting sphingolipid species which will be acquired.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Sep 2022
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physiological Response of Sphingolipids to a Single HIIT SessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective 2-arm, monocentric randomised controlled trial (a single HIIT session vs. no exercise intervention).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Principal investigator, Justin Carrard, University of Basel
- Investigators
- Arno Schmidt-Trucksäss, Prof, Study chair, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390866
- Sponsor's protocol ID
- EKNZ 2022-00513
- Acronym
- SphingoHIIT
- Status last verified
- May 2025
- First submitted
- 19 May 2022
- Last updated
- 15 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33772258Laaksonen 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.
PubMed 27125947Tippetts 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.
PubMed 34750017Carrard 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.
PubMed 34677390Carrard 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.
PubMed 37533665
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05390866
- Acronym / sponsor ID
- SphingoHIIT / EKNZ 2022-00513
- Keywords
- Metabolomics, Lipidomics, High-intensity interval training, Ceramides, Sphingolipids, Cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- University of Lausanne
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Growing scientific evidence shows that specific sphingolipids, known as ceramides, predict cardiovascular risk beyond traditionally used biomarkers such as lipoproteins and triglycerides. Mechanistically, ceramides have been shown to promote foam cell formation, vascular inflammation, peripheral insulin resistance, and ultimately atherosclerosis. Currently, however, it remains unclear if and how physical activity, a simple, low-cost, and patient-empowering mean to optimise cardiometabolic health, can mitigate sphingolipid levels. The SphingoHIIT study aims to assess how certain circulating sphingolipid species respond to a single session of high-intensity interval training (HIIT). We hypothesise that circulating sphingolipid levels will be temporarily increased following a single HIIT session. This risk category A study will last 11 days and include 32 healthy participants aged between 20 and 29 years (50% of females). Participants will be randomly allocated either to the intervention group (n= 16) or the control group (n= 16). Blocked randomisation will be used to reduce bias and achieve balance in the allocation of participants to both groups, as commonly done when the sample size is small. Following an assessment of inclusion and exclusion criteria, a maximal cardiopulmonary exercise testing will be performed to determine peak oxygen uptake and peak heart rate. A washout period of five days will then be carried out before participants start to self-sample fasted dried blood spots to determine baseline levels of sphingolipids. After three days of sampling, participants will undergo a single HIIT session. Dried blood spots will be collected at five additional fixed time points (2min, 15min, 30min, 60min, and 24h) following the HIIT session. To minimise the dietary influence, participants will be asked to solely consume the provided individualised, pre-packaged meals starting one day before the first dried blood sampling.
Additionally, for the duration of the whole study, participants will wear a wrist accelerometer to track their physical activity. The SphingoHIIT study is expected to provide novel knowledge regarding the effect of an acute bout of physical exercise on sphingolipid levels. The results of this study will be published in a peer-reviewed journal and will be presented at scientific conferences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A prospective 2-arm, monocentric randomised controlled trial (a single HIIT session vs. no exercise intervention).
| Arm | Type | Receives |
|---|---|---|
| HIIT group | Experimental | Other: HIITThe 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 intervention | –The 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. |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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+),
Key exclusion criteria (10 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIITA single HIIT on a bicycle ergometer | Other | HIIT group |
Primary outcome
Concentration of circulating Cer16:0, Cer18:0, Cer24:0 and Cer24:1
Time frame: 72 hours
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.
1 secondary outcome
Concentration of the resting circulating sphingolipid species to be acquired
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Results publication: PubMed 33772258Choi 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.
- Results publication: PubMed 27125947Laaksonen 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.
- Results publication: PubMed 34750017Tippetts 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.
- Results publication: PubMed 34677390Carrard 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.
- Derived from this study: PubMed 37533665Carrard 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arno Schmidt-Trucksäss, Prof study chair
Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT in people with Physiological Response of Sphingolipids to a Single HIIT Session, run by University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of circulating Cer16:0, Cer18:0, Cer24:0 and Cer24:1 (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05390866, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.