Overweight and ObesitySphingoFITNCT06024291
Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Trial
A study testing 8-week HIIT programme and Physical activity recommendation in people with Overweight and Obesity and Dyslipidemias, run by University of Basel at 1 site in Switzerland.
Trial 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 comprehensive panel of circulating sphingolipids in middle-aged females and males at elevated cardiometabolic risk. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Overweight and Obesity, Dyslipidemias, Blood Pressure
- What is being tested?
- 8-week HIIT programme and Physical activity recommendation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2023to 15 Jan 2025
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Sport, Exercise and Health, University of Basel
Basel, Canton of Basel-City, 4052
About this study
Official title: Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Randomised Controlled Exercise Trial
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 comprehensive panel of circulating sphingolipids in middle-aged females and males at elevated cardiometabolic risk.
Read the 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 on health systems, a shift towards more effective prevention and early detection of these diseases is urgently needed.
Blood lipids have been used since the middle of the last century to determine the risk of developing CMD. Although classically used biomarkers such as cholesterol and triglycerides provide acceptable risk assessment, there is increasing evidence that sphingolipids, particularly ceramides, may allow improved risk assessment. Mechanistically, there is growing data that sphingolipid accumulations lead to atherosclerosis and insulin resistance.
To measure circulating sphingolipids in clinical practice, it is essential to provide patients with evidence-based interventions that reduce sphingolipid levels and quantify the reduction expected from such an intervention. Preliminary data suggest that regular physical activity (PA), an effective, low-cost, and patient-empowering means of health optimisation, may reduce sphingolipid levels.
The current research project aims to explore whether and to what extent a fitness-enhancing high-intensity interval training (HIIT) programme can lower circulating sphingolipid levels in middle-aged individuals at elevated cardiometabolic risk (50% females). An 'omic-scale sphingolipid profiling will be applied to capture the circulating sphingolipidome comprehensively.
Participants will be randomly allocated to either the intervention or the control group. The exercise intervention will consist of an 8-week supervised HIIT (two walking- and one indoor cycling-based session weekly). The control group will get PA recommendations based on current guidelines.
Maximal cardiopulmonary exercise testing (CPET) will be conducted on a cycle ergometer to determine the VO2peak, peak heart rate and peak power output. After the 8-week training programme, a second CPET will be performed to verify if the exercise intervention effectively improved CRF. Body composition will be analysed before and after the 8-week intervention by dual-energy x-ray absorptiometry and by bioelectrical impedance analysis.
Trained medical staff will draw blood samples by venepuncture of the cubital fossa following an overnight fast pre- and post-intervention. Planned blood analyses for basic characterisation of risk factor profiles include total cholesterol, low-density lipoprotein cholesterol (LDL) and high-density lipoprotein cholesterol (LDL), triglycerides, and HbA1c. Glucose and insulin will also be measured to estimate insulin resistance using the HOMA-IR. A high-coverage method using reversed-phase liquid chromatography coupled to tandem mass spectrometry (RPLC-MS/MS) will be applied to quantify an extensive panel of circulating sphingolipids (n=61).
Retinal vessel diameters, a novel surrogate of microvascular health that responds positively to exercise interventions, will be assessed pre- and post-intervention, and the brachial artery FMD, which reflects endothelial function as an early marker of atherosclerotic arterial damage.
Each participant will receive individualised, pre-packaged meals for the two days preceding blood sampling to minimise potential confounding. All participants will be fed to energy balance. To monitor diet adherence, participants will be instructed to return all non-consumed foods from the pre-packaged meals to the lab and take photos of additionally consumed foods for later analysis.
- Conditions
- Overweight and Obesity, Dyslipidemias, Blood Pressure, Cardiovascular Diseases, Metabolic Disease
- Being tested
- 8-week HIIT programme, Physical activity recommendation
- Medical subject headings
- Overweight, Obesity, Dyslipidemias, Cardiovascular Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week HIIT programmeOther
See arm description
Physical activity recommendationOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| HIIT group | Experimental | The exercise intervention will consist of a supervised HIIT (two walking- and one indoor cycling-based session weekly), starting with a habituation week at an intensity of 75% of the maximal heart rate (HRmax). In the following seven weeks, the participants will perform a HIIT based on the following protocol and for a total duration of 45 min per session: warm-up for 10 min at 60%-70% HRmax followed by a high-intensity interval consisting of 4×4 min at 80%-95% HRmax with 3 min of active recovery at 60%-70% HRmax and a 10 min cool-down at 60%-70% HRmax. Heart rate will be monitored during training by Garmin HRM-Dual heart rate sensors combined with Garmin Forerunner 45S watches. Exercise scientists motivate the participants during the intervals and will control each participant's heart rate during and after every training session. Receives: Other: 8-week HIIT programme |
| Physical activity recommendation group | Active comparator | Asking physically inactive participants to maintain their inactive habits may not reflect realistic conditions and is no longer considered the best option in a randomised controlled exercise intervention. Indeed, most participants will be aware of the positive effects of PA - or will become aware of them during an exercise intervention study. Further, denying an exercise intervention to participants who would have benefited from it (for instance, participants at risk of cardiometabolic diseases) might be ethically questionable. In accordance with current practices, control group participants will be informed about the World Health Organization physical activity guidelines at the beginning of the study. Receives: Other: Physical activity recommendation |
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 plasma level of the four sphingolipid species included in the ceramide-based scores (Cer16:0, Cer18:0, Cer24:0 and Cer24:1) following the 8-week HIIT programme (vs. physical activity recommendation).
Measured: At baseline and after the 8-week intervention
Secondary outcomes (5)
Concentration of the other circulating sphingolipid species to be targeted
Quantifying the changes in plasma level of the other sphingolipids to be targeted following the 8-week HIIT programme (vs. physical activity recommendation).
Measured: At baseline and after the 8-week intervention
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Quantifying the changes in HOMA-IR following the 8-week HIIT programme (vs. physical activity recommendation).
Measured: At baseline and after the 8-week intervention
Peak oxygen uptake (VO2peak)
Quantifying the changes in VO2peak following the 8-week HIIT programme (vs. physical activity recommendation).
Measured: At baseline and after the 8-week intervention
Retinal microvascular diameters
Quantifying the changes in retinal microvascular diameters following the 8-week HIIT programme (vs. physical activity recommendation).
Measured: At baseline and after the 8-week intervention
Brachial flow-mediated dilatation (FMD)
Quantifying the changes in FMD following the 8-week HIIT programme (vs. physical activity recommendation).
Measured: At baseline and after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start15 Sep 2023
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
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 Overweight and ObesityStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne, Technical University of Munich
- Responsible party
- Principal investigator, Justin Carrard, University of Basel
- Investigators
- Arno Schmidt-Trucksäss, Prof, MD, MA, Study chair, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024291
- Sponsor's protocol ID
- EKNZ 2023-01345
- Acronym
- SphingoFIT
- Status last verified
- May 2025
- First submitted
- 28 Aug 2023
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- 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, 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 37533665Carrard J, Hofer M, Prechtl L, Fleischlin E, Huber M, Gallart-Ayala H, Teav T, Infanger D, Hochsmann C, Koehler K, Hinrichs T, Hanssen H, Ivanisevic J, Schmidt-Trucksass A. Effect of an eight-week high-intensity interval training programme on circulating sphingolipid levels in middle-aged adults at elevated cardiometabolic risk (SphingoFIT)-Protocol for a randomised controlled exercise trial. PLoS One. 2024 May 8;19(5):e0302477. doi: 10.1371/journal.pone.0302477. eCollection 2024.
PubMed 38717997
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
- Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Randomised Controlled Exercise Trial
- ClinicalTrials.gov ID
- NCT06024291
- Acronym / sponsor ID
- SphingoFIT / EKNZ 2023-01345
- Conditions
- Overweight and Obesity, Dyslipidemias, Blood Pressure, Cardiovascular Diseases, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- University of Lausanne, Technical University of Munich
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 6 Sep 2023 (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 assess the effects of an 8-week supervised high-intensity interval training (HIIT) program (vs. physical activity recommendations according to current guidelines) on a comprehensive panel of circulating sphingolipids in middle-aged females and males at elevated cardiometabolic risk.
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 on health systems, a shift towards more effective prevention and early detection of these diseases is urgently needed.
Blood lipids have been used since the middle of the last century to determine the risk of developing CMD. Although classically used biomarkers such as cholesterol and triglycerides provide acceptable risk assessment, there is increasing evidence that sphingolipids, particularly ceramides, may allow improved risk assessment. Mechanistically, there is growing data that sphingolipid accumulations lead to atherosclerosis and insulin resistance.
To measure circulating sphingolipids in clinical practice, it is essential to provide patients with evidence-based interventions that reduce sphingolipid levels and quantify the reduction expected from such an intervention. Preliminary data suggest that regular physical activity (PA), an effective, low-cost, and patient-empowering means of health optimisation, may reduce sphingolipid levels.
The current research project aims to explore whether and to what extent a fitness-enhancing high-intensity interval training (HIIT) programme can lower circulating sphingolipid levels in middle-aged individuals at elevated cardiometabolic risk (50% females). An 'omic-scale sphingolipid profiling will be applied to capture the circulating sphingolipidome comprehensively.
Participants will be randomly allocated to either the intervention or the control group. The exercise intervention will consist of an 8-week supervised HIIT (two walking- and one indoor cycling-based session weekly). The control group will get PA recommendations based on current guidelines.
Maximal cardiopulmonary exercise testing (CPET) will be conducted on a cycle ergometer to determine the VO2peak, peak heart rate and peak power output. After the 8-week training programme, a second CPET will be performed to verify if the exercise intervention effectively improved CRF. Body composition will be analysed before and after the 8-week intervention by dual-energy x-ray absorptiometry and by bioelectrical impedance analysis.
Trained medical staff will draw blood samples by venepuncture of the cubital fossa following an overnight fast pre- and post-intervention. Planned blood analyses for basic characterisation of risk factor profiles include total cholesterol, low-density lipoprotein cholesterol (LDL) and high-density lipoprotein cholesterol (LDL), triglycerides, and HbA1c. Glucose and insulin will also be measured to estimate insulin resistance using the HOMA-IR. A high-coverage method using reversed-phase liquid chromatography coupled to tandem mass spectrometry (RPLC-MS/MS) will be applied to quantify an extensive panel of circulating sphingolipids (n=61).
Retinal vessel diameters, a novel surrogate of microvascular health that responds positively to exercise interventions, will be assessed pre- and post-intervention, and the brachial artery FMD, which reflects endothelial function as an early marker of atherosclerotic arterial damage.
Each participant will receive individualised, pre-packaged meals for the two days preceding blood sampling to minimise potential confounding. All participants will be fed to energy balance. To monitor diet adherence, participants will be instructed to return all non-consumed foods from the pre-packaged meals to the lab and take photos of additionally consumed foods for later analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT group | Experimental | Other: 8-week HIIT programmeThe exercise intervention will consist of a supervised HIIT (two walking- and one indoor cycling-based session weekly), starting with a habituation week at an intensity of 75% of the maximal heart rate (HRmax). In the following seven weeks, the participants will perform a HIIT based on the following protocol and for a total duration of 45 min per session: warm-up for 10 min at 60%-70% HRmax followed by a high-intensity interval consisting of 4×4 min at 80%-95% HRmax with 3 min of active recovery at 60%-70% HRmax and a 10 min cool-down at 60%-70% HRmax. Heart rate will be monitored during training by Garmin HRM-Dual heart rate sensors combined with Garmin Forerunner 45S watches. Exercise scientists motivate the participants during the intervals and will control each participant's heart rate during and after every training session. |
| Physical activity recommendation group | Active comparator | Other: Physical activity recommendationAsking physically inactive participants to maintain their inactive habits may not reflect realistic conditions and is no longer considered the best option in a randomised controlled exercise intervention. Indeed, most participants will be aware of the positive effects of PA - or will become aware of them during an exercise intervention study. Further, denying an exercise intervention to participants who would have benefited from it (for instance, participants at risk of cardiometabolic diseases) might be ethically questionable. In accordance with current practices, control group participants will be informed about the World Health Organization physical activity guidelines at the beginning of the study. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (13 listed)
- 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,
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 |
|---|---|---|
| 8-week HIIT programmeSee arm description | Other | HIIT group |
| Physical activity recommendationSee arm description | Other | Physical activity recommendation group |
Primary outcome
Concentration of circulating Cer16:0, Cer18:0, Cer24:0 and Cer24:1
Time frame: At baseline and after the 8-week intervention
Quantifying the changes in plasma level of the four sphingolipid species included in the ceramide-based scores (Cer16:0, Cer18:0, Cer24:0 and Cer24:1) following the 8-week HIIT programme (vs. physical activity recommendation).
5 secondary outcomes
Concentration of the other circulating sphingolipid species to be targeted
Time frame: At baseline and after the 8-week intervention
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: At baseline and after the 8-week intervention
Peak oxygen uptake (VO2peak)
Time frame: At baseline and after the 8-week intervention
Retinal microvascular diameters
Time frame: At baseline and after the 8-week intervention
Brachial flow-mediated dilatation (FMD)
Time frame: At baseline and after the 8-week intervention
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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Derived from this study: PubMed 38717997Carrard J, Hofer M, Prechtl L, Fleischlin E, Huber M, Gallart-Ayala H, Teav T, Infanger D, Hochsmann C, Koehler K, Hinrichs T, Hanssen H, Ivanisevic J, Schmidt-Trucksass A. Effect of an eight-week high-intensity interval training programme on circulating sphingolipid levels in middle-aged adults at elevated cardiometabolic risk (SphingoFIT)-Protocol for a randomised controlled exercise trial. PLoS One. 2024 May 8;19(5):e0302477. doi: 10.1371/journal.pone.0302477. eCollection 2024.
- Individual participant dataSharing planned: No
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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, MD, MA 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 8-week HIIT programme and Physical activity recommendation in people with Overweight and Obesity and Dyslipidemias, 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 6 inclusion and 13 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: At baseline and after the 8-week intervention). 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 NCT06024291, 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.