Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Trial
SphingoFIT
SphingoFIT
Sponsor study identifier
interventional
88
1 country
1
Study Start
September 15, 2023
Actual (reported)Primary Completion
January 15, 2025
Actual (reported)Study Completion
January 15, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 15, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 28, 2023
Actual (reported)September 6, 2023
Actual (reported)September 15, 2023
Actual (reported)January 15, 2025
Actual (reported)January 15, 2025
Actual (reported)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).
At baseline and after the 8-week intervention
Concentration of the other circulating sphingolipid species to be targeted
At baseline and after the 8-week intervention
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
At baseline and after the 8-week intervention
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.
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.
See arm description
See arm description
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Sport, Exercise and Health, University of Basel
Basel, Canton of Basel-City, 4052, Switzerland
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.
Laaksonen 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.
Arno Schmidt-Trucksäss, Prof, MD, MA
Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
88 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2023
First Posted
September 6, 2023
Study Start
Dose Response Effects of Pecan Consumption
Peak oxygen uptake (VO2peak)
At baseline and after the 8-week intervention
Retinal microvascular diameters
At baseline and after the 8-week intervention
Brachial flow-mediated dilatation (FMD)
At baseline and after the 8-week intervention
Contact the study team to confirm eligibility.
Tippetts 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.
Carrard 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.
Carrard 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.
September 15, 2023
Primary Completion
January 15, 2025
Actual (reported)Study Completion
January 15, 2025
Actual (reported)Last Updated
May 15, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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