NCT04753021

Brief Summary

In this study 11 healthy volunteers will perform high intensity exercise training during 4 weeks. The exercise frequency will increase progressively during the first three weeks, followed by a fourth week with lower exercise frequency. 5 skeletal muscle biopsies will be donated throughout the study and 4 oral glucose tolerance tests will be performed after each training period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 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

Study Start

First participant enrolled

February 2, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

February 4, 2021

Last Update Submit

April 11, 2023

Conditions

Mitochondrial FunctionGlucose Intolerance

Outcome Measures

Primary Outcomes (1)

  • Change in mitochondrial respiration

    Measurement of mitochondrial oxygen consumption in isolated mitochondria from Vastus Lateralis. Respiration will be assessed using substrate combinations targeting both complex I and II. Assessment will be performed in an Oroboros oxygraph

    At baseline (before exercise training), after 1 week of training, after 2 weeks of training, after 3 weeks of training, after 4 weeks of training

Secondary Outcomes (2)

  • Change in glucose tolerance

    At baseline (before exercise training), after 1 week of training, after 3 weeks of training, after 4 weeks of training

  • Change in oxidative stress

    At baseline (before exercise training), after 1 week of training, after 2 weeks of training, after 3 weeks of training, after 4 weeks of training

Study Arms (1)

Exercise

EXPERIMENTAL

Progressive exercise training

Other: Exercise

Interventions

ExerciseOTHER

Progressively increasing training load

Exercise

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \* Healthy

You may not qualify if:

  • Endurance training of more than 5 hours a week
  • regularly performing high intensity interval training (HIIT).
  • Chronic medication,
  • chronic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Swedish School of Sport and Health Sciences (GIH)

Stockholm, 114 86, Sweden

Location

Related Publications (2)

  • Flockhart M, Nilsson LC, Ekblom B, Larsen FJ. A Simple Model for Diagnosis of Maladaptations to Exercise Training. Sports Med Open. 2022 Nov 4;8(1):136. doi: 10.1186/s40798-022-00523-x.

    PMID: 36333619DERIVED

  • Flockhart M, Nilsson LC, Tais S, Ekblom B, Apro W, Larsen FJ. Excessive exercise training causes mitochondrial functional impairment and decreases glucose tolerance in healthy volunteers. Cell Metab. 2021 May 4;33(5):957-970.e6. doi: 10.1016/j.cmet.2021.02.017. Epub 2021 Mar 18.

    PMID: 33740420DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Filip J Larsen, PhD

    The Swedish School of Sport and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 12, 2021

Study Start

February 2, 2018

Primary Completion

November 11, 2020

Study Completion

March 23, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)