Clinical trial NCT02951624: The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors
Official title: The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Overweight and Obesity
Metabolic Disease
Keywords: Exercise
Breaking prolonged sitting
physical activity
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to investigate the acute effect of the frequency and duration of breaks in sitting time on the metabolic risk factor profile.

Detailed description: Fifteen (n=15) sedentary adult overweight males will be included in the study. All participants will undergo the four interventions in a randomized cross-over design. Wash out between intervention will be minimum four days.

Control (CON): Participants will be sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.), with a target MET below 1.5 (i.e. 1.5 times REE). Participants will only be allowed to stand or walk to go to the toilet.

Breaker: Participants will be breaking up prolonged sitting with 2 min intervals of low intensity walking.

Intermediate: Participants will be breaking up prolonged sitting with 6 min intervals of low intensity walking

Prolonger: Participants will be breaking up prolonged sitting with 12 min intervals of low intensity walking

All interventions will be matched for total physical activity as well as sitting. Thus, we aim for the active interventions to be iso-caloric.

Eligibility criteria: Inclusion Criteria:

* Males, age 20-50 years, waist-to-height ratio ≥ 0.5 and/or waist circumference ≥ 102 cm.

Exclusion Criteria:

* Clinically diagnosed diabetes, uncontrolled hypertension, use of glucose- and/or lipid-lowering medication, smoking, evidence of thyroid, liver, lung, heart or kidney disease, non-sedentary occupation, and VO2max levels above the considered average fitness according to age (Shvartz \& Reibold 1990), contraindications to increased levels of physical activity.

Primary outcomes:
measure: AUC post prandial glucose concentration
timeFrame: 6 hours
Secondary outcomes:
measure: AUC post prandial insulin concentration
timeFrame: 6 hours
measure: AUC post prandial c-peptide concentration
timeFrame: 6 hours
measure: AUC post prandial triglyceride concentration
timeFrame: 6 hours
measure: AUC post prandial total cholesterol concentration
timeFrame: 6 hours
measure: AUC post prandial ldl concentration
timeFrame: 6 hours
measure: AUC post prandial hdl concentration
timeFrame: 6 hours
measure: AUC post prandial glucagon concentration
timeFrame: 6 hours
measure: Mean 24 hour glucose concentration
timeFrame: 24 hours
measure: Variation in 24 hour glucose concentration
timeFrame: 24 hours
measure: Maximum in 24 hour glucose concentration
timeFrame: 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Physical Activity Research, Copenhagen University Hospital
Study officials:
affiliation: Group leader
name: Mathias Ried, PhD
role: PRINCIPAL_INVESTIGATOR
References: