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CompletedNCT04753021Updated Apr 12, 2023

Dose-response Relationship Between Exercise and Health Outcomes

An interventional study of Exercise in Mitochondrial Function and Glucose Intolerance, sponsored by The Swedish School of Sport and Health Sciences. Completed at 1 site in Sweden. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by The Swedish School of Sport and Health Sciences · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Feb 2018, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

11 healthy and recreational active subjects will be recruited to the study. For inclusion and assessment of baseline physiological characteristics during cycling, a pre-test will be performed on a cycle ergometer and the submaximal and maximal response to exercise will be determined by measurement of respiratory gas exchange. The physiological response to submaximal work rate will be comprised of a series of five minutes long intervals separated with one minutes of rest with assessment of capillary blood lactate and glucose at the end of each workload. All physiological tests and training (HII) sessions will be carefully supervised by trained personnel. The intervention period will include 14 HIIT-sessions in total, all performed at the laboratory under close surveillance and careful monitoring of power output and heart rate. During HIIT sessions, VO2, CO2, blood glucose, lactate and rating of perceived exhaustion (BORG) will be measured.

Energy intake will be standardized for each subject during the day of test sessions. After each HIIT-session a recovery drink containing 1 g · kg-1 bw of carbohydrates and 0.25 g · kg-1 bw of protein will be ingested by the subjects. After HIIT sessions, subjects will be supplied with an evening meal consisting of 74 g carbohydrates, 38 g protein and 26 g fat to be consumed two hours post exercise. Subjects will thereafter remain fasted until the next morning for an oral glucose tolerance test (OGTT) and donation of a muscle biopsy.

All biopsies will be collected in fasted state in early morning following 14 hour of rest after the last HIIT-session. Biopsies will be taken from vastus lateralis in alternating leg in randomized order.

Each subject will complete four OGTTs throughout the study. Resting metabolic rate (RMR) will be measured in supine position by gas exchange measurement using mixing chamber method (Oxycon Pro) attached to a ventilated hood. Thereafter the muscle biopsy will be taken and a catheter will be inserted into the antecubital vein of the forearm. After 10 minutes of passive rest 75 mg glucose dissolved in 300 ml water will be ingested and at 0, 15, 30, 45, 60 75, 90, 105- and 120-minutes after glucose intake a venous blood sample will be taken and instantly analyzed for glucose with enzymatic method in the Biosen C-Line Clinic. Additional RMR measurements will be performed at \~40 and 115 minutes after glucose ingestion.

Mitochondria will be isolated from fresh skeletal muscle biopsies. Mitochondrial respiration and H2O2 emission will be measured using a two-channel high-resolution respirometer with an attached fluorescent probe (Oxygraph-2k, Oroboros Instruments Corporation, Innsbruck, Austria).

02

Conditions studied

  • Mitochondrial Function
  • Glucose Intolerance

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03

In context

Glucose Intolerance

778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.

This study's enrollment of 11 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

The Swedish School of Sport and Health Sciences is the lead sponsor of 12 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

* Healthy

Exclusion criteria

Exclusion Criteria:

  • Endurance training of more than 5 hours a week
  • regularly performing high intensity interval training (HIIT).
  • Chronic medication,
  • chronic diseases.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Exercise

    Progressive exercise training

    Other: Exercise

Interventions

  • OtherExercise

    Progressively increasing training load

06

What researchers measure

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

    Time frame: 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

  1. Change in glucose tolerance

    Measurement of blood glucose response to 75g oral glucose

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

  2. Change in oxidative stress

    Measurement of carboylated proteins in skeletal muscle biopsies using a commercial ELISA kit

    Time frame: 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

07

Study locations

1 site
  • The Swedish School of Sport and Health Sciences (GIH)
    Stockholm, 114 86, Sweden
08

References and documents

Publications

  • 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. PubMed 36333619 ↗
  • 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. PubMed 33740420 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04753021
Lead sponsor
The Swedish School of Sport and Health Sciences
Collaborators
Swedish Research Council for Sport Science
Responsible party
Sponsor
First posted
Feb 12, 2021
Start date
Feb 2, 2018
Primary completion
Nov 11, 2020
Completion
Mar 23, 2023
Last update
Apr 12, 2023

Study contacts

Filip J Larsen, PhD
principal investigator · The Swedish School of Sport and Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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