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.

Abstract

Introduction: Evidence indicates that sphingolipid accumulation drives complex molecular alterations promoting cardiometabolic diseases. Clinically, it was shown that sphingolipids predict cardiometabolic risk independently of and beyond traditional biomarkers such as low-density lipoprotein cholesterol. To date, little is known about therapeutic modalities to lower sphingolipid levels. Exercise, a powerful means to prevent and treat cardiometabolic diseases, is a promising modality to mitigate sphingolipid levels in a cost-effective, safe, and patient-empowering manner.

Methods: This randomised controlled trial will explore whether and to what extent an 8-week fitness-enhancing training programme can lower serum sphingolipid levels of middle-aged adults at elevated cardiometabolic risk (n = 98, 50% females). The exercise intervention will consist of supervised high-intensity interval training (three sessions weekly), while the control group will receive physical activity counselling based on current guidelines. Blood will be sampled early in the morning in a fasted state before and after the 8-week programme. Participants will be provided with individualised, pre-packaged meals for the two days preceding blood sampling to minimise potential confounding. An 'omic-scale sphingolipid profiling, using high-coverage reversed-phase liquid chromatography coupled to tandem mass spectrometry, will be applied to capture the circulating sphingolipidome. Maximal cardiopulmonary exercise tests will be performed before and after the 8-week programme to assess patient fitness changes. Cholesterol, triglycerides, glycated haemoglobin, the homeostatic model assessment for insulin resistance, static retinal vessel analysis, flow-mediated dilatation, and strain analysis of the heart cavities will also be assessed pre- and post-intervention. This study shall inform whether and to what extent exercise can be used as an evidence-based treatment to lower circulating sphingolipid levels.

Trial registration: The trial was registered on www.clinicaltrials.gov (NCT06024291) on August 28, 2023.

Publication types

  • Research Support, Non-U.S. Gov't
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Biomarkers / blood
  • Cardiometabolic Risk Factors
  • Cardiovascular Diseases / blood
  • Cardiovascular Diseases / prevention & control
  • Exercise / physiology
  • Exercise Therapy / methods
  • Female
  • High-Intensity Interval Training* / methods
  • Humans
  • Male
  • Middle Aged
  • Sphingolipids* / blood

Substances

  • Sphingolipids
  • Biomarkers

Associated data

  • ClinicalTrials.gov/NCT06024291

Grants and funding

This study is supported by the Swiss National Research Foundation (awarded to JD, ID CRSK-3_220309, https://www.snf.ch/en/8EWqXT6CZ7wuAJUq/funding/programmes/spark), by the Research Fund of the University of Basel for Excellent Junior Researchers (awarded to JC, ID U.360.0002, https://www.unibas.ch/en/Research/Individual-Funding/Research-Fund.html) and by the Swiss Life Jubilee Foundation (awarded to JC, no ID, https://www.swisslife.ch/de/ueber-uns/engagement/stiftungen/jubilaeumsstiftung.html). The funders had no role in study design, data collection and analysis, publication decisions, or manuscript preparation. There was no additional external funding received for this study.