NCT05622006

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 and investigating the patterns 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 pattern for sedentary bouts and breaks and physical activity intensity during sedentary breaks matter. Specifically, the aims of the PhD-project are to provide knowledge on the following questions: • How does different patterns of accumulation of sedentary bouts and 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 May 2022

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

May 2, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

November 4, 2022

Last Update Submit

January 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • iAUC analyses for insulin, c-peptide, triglycerides and 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 - Trail making test A and B

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

  • Cognitive function - Stroop-test.

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

Study Arms (4)

Control condition

EXPERIMENTAL

Control condition: Sitting from 8 am until 3pm.

Behavioral: Sedentary breaks

Condition 1

EXPERIMENTAL

Condition 1: 35 minutes of treadmill walking followed by sitting until hour 7 is reached

Behavioral: Sedentary breaks

Condition 2

EXPERIMENTAL

Condition 2: 2.5 minutes of treadmill walking for every 30 minutes until hour 7 is reached.

Behavioral: Sedentary breaks

Condition 3

EXPERIMENTAL

Condition 3: 5 minutes of treadmill walking every 60 minutes, until hour 7 is reached.

Behavioral: Sedentary breaks

Interventions

Interrupting sitting with different frequencies of walking/jogging at moderate intensity.

Condition 1Condition 2Condition 3Control condition

Eligibility Criteria

Age20 Years - 40 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 BehaviorMetabolic SyndromeMotor Activity

Condition Hierarchy (Ancestors)

BehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jostein Steene-Johannessen, Professor

    Norwegian School of Sport 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 4 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 4 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 corresponding to 60-65% of their individual VO2max values, estimated from the individual's pre-test. The volume of sedentary- and physical activity time will be identical in each trial condition. 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

November 4, 2022

First Posted

November 18, 2022

Study Start

May 2, 2022

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations