NCT05709379

Brief Summary

The knowledge gap on sedentary behavior and sedentary breaks includes whether detrimental effects of sedentary behavior can be fully attenuated by 1.) sedentary breaks 2.) physical activity or 3.) both combined. Specifically, when breaking sedentary time which physical activity pattern- and intensity modifies the negative effects of sedentary behavior on glucose- and lipid metabolism? This lack of quantitative evidence calls for prospective experimental studies investigating the physiological and biological impacts of sedentary behavior, as well as the effectiveness of different strategies to reduce sedentary time. Thus, quantifying effects of the intensity, frequency, volume of sedentary breaks and/or physical activity on predefined outcomes is of importance. Aims: Our primary aims are to investigate the effects of breaking up sedentary time on glucose- and lipid metabolism and thus examine whether physical activity intensity breaks during sedentary breaks matter. Specifically, the aims of the PhD-project are to provide knowledge on the following questions: • How does high- or low physical activity intensity sedentary breaks acutely influence glucose- and lipid metabolism under iso-caloric conditions?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

January 6, 2023

Last Update Submit

January 17, 2026

Conditions

Sedentary BehaviorPhysical Activity

Keywords

Sedentary behaviorPhysical ActivityCardiometabolicCardiovascularSitting

Outcome Measures

Primary Outcomes (1)

  • Total (tAUC)- and incremental areas under the curve (iAUC) for glucose

    During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition

    The iAUC for glucose will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

Secondary Outcomes (5)

  • tAUC and iAUC analyses for insulin

    The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

  • tAUC and iAUC analyses for c-peptide

    The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

  • tAUC and iAUC analyses for triglycerides

    The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

  • tAUC and iAUC analyses for lipids

    The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

  • Cognitive function and performance

    The cognitive measures will be performed during the procedure (at approx 400 minutes)

Study Arms (3)

Control trial

EXPERIMENTAL

Sitting from 8 am until 3pm.

Behavioral: Sedentary behavior

High intensity sedentary breaks

EXPERIMENTAL

Physical activity on 80-85% of individual VO2max every hour. Modality: Hill walking/jogging on treadmill.

Behavioral: Sedentary behavior

Low intensity sedentary breaks

EXPERIMENTAL

Physical activity on 25-30% of individual VO2max every hour. Modality: Hill walking on treadmill.

Behavioral: Sedentary behavior

Interventions

Sedentary behaviorBEHAVIORAL

Interrupting sitting with walking/jogging at either high -or low physical activity intensity.

Control trialHigh intensity sedentary breaksLow intensity sedentary breaks

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Predominantly sedentary occupation.
  • Physical activity: equal or less tham 150 minutes /week
  • Nonobese. Central adiposity: Waist circumference equal or less than 102 cm for men and equal or less than \< 88 cm for women. BMI \< 30 km·m2

You may not qualify if:

  • Shift-work
  • Smoking
  • Pregnancy
  • Current use of medication, except from hormonal contraceptives.
  • No presence of any co-morbidity (e.g. diabetes type 2, cardiovascular or cardiorespiratory disease, or other conditions known to affect carbohydrate and lipid metabolism - thyroid-, -liver or kidney).
  • Systolic /diastolic resting blood pressure: \> 140/90 mmHg
  • Fasting blood glucose concentration: \> 6.1 mmol/L
  • Abnormal total cholesterol, LDL, LDL or triglyceride concentrations (\> 50% above recommendations)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sports Sciences

Oslo, Oslo County, 0806, Norway

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jostein Steene-Johennessen, Professor

    Norwegian School of Sports Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This study will be conducted as randomized controlled crossover trials involving 3 different trial conditions in each of the studies. Randomization will be stratified based on sex. The order of trials will be assigned randomly by a third party using a computer software. After pre-testing and familiarization (visit 1), the participants will undergo 3 different trial conditions of 7 hours. The trials are all iso-caloric, but with different intervals of sitting and executing moderate physical activity by treadmill walking/running corresponding to 25-30% or 80-85%, repectively of their individual VO2max values, estimated from the individual's pre-test. Blood samples will be taken and blood pressure measured every 30 minutes. The visits for main testing will be separated by a washout period of minimum 5 days, and women will be tested in the follicular phase.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2023

First Posted

February 2, 2023

Study Start

January 2, 2023

Primary Completion

December 20, 2025

Study Completion

December 20, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)