NCT05390866

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 19, 2022

Last Update Submit

May 12, 2025

Conditions

Keywords

MetabolomicsLipidomicsHigh-intensity interval trainingCeramidesSphingolipidsCardiometabolic health

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

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.

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.

Interventions

HIITOTHER

A single HIIT on a bicycle ergometer

HIIT group

Eligibility Criteria

Age20 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

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

Location

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: 33772258BACKGROUND
  • 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.

    PMID: 27125947BACKGROUND
  • 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.

    PMID: 34750017BACKGROUND
  • Carrard 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: 34677390BACKGROUND
  • 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.

Study Officials

  • Arno Schmidt-Trucksäss, Prof

    Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland

    STUDY CHAIR

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
Model Details: A prospective 2-arm, monocentric randomised controlled trial (a single HIIT session vs. no exercise intervention).
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

Locations