NCT02870088

Brief Summary

The purpose of this project is to investigate the effect of breaking prolonged sitting on acute adipose tissue and metabolic responses.

Trial Health

100
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 Jul 2014

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

July 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

February 9, 2016

Last Update Submit

August 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incremental area under curve (iAUC) for insulin

    330 minutes

Secondary Outcomes (4)

  • Changes in gene expression in the adipose tissue

    Before the 1st meal and 120 min after the 2nd meal (330 minutes).

  • Changes in insulin, glucose, TAG and NEFA in blood

    330 minutes

  • Changes in serum Interleukin-6 (IL-6), leptin and adiponectin

    330 minutes

  • Changes in Interleukin-6 (IL-6), leptin and adiponectin protein secretion from adipose tissue explants

    Before the 1st meal and 120 min after the 2nd meal (330 minutes).

Study Arms (2)

Prolonged Sitting

ACTIVE COMPARATOR

Participants sat on a chair during the trial.

Behavioral: Prolonged Sitting

Breaking Sitting

EXPERIMENTAL

Participants walked regularly during the trial.

Behavioral: Breaking Sitting

Interventions

After consuming 1st meal, participants sat on a chair for 180 min. After 180 min, the 2nd meal was provided. After finishing the 2nd meal, participants sat on a chair for another 120 min.

Prolonged Sitting

After consuming 1st meal, participants walked 2 min on a treadmill every 20 minutes for the following 180 min. For the remainder of the time participants sat on the chair. After 180 min, the 2nd meal was provided. After finishing the 2nd meal, participants continued 2 min of walking every 20 min for the following 120 min.

Breaking Sitting

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and post-menopausal females (post-menopausal diagnosis based on consecutive absence of menstrual cycles for \>12 months).
  • Aged between 35 and 64 years
  • Central overweight (waist circumference greater than 94 cm for males and 80 cm for females)
  • Weight stable for more than 3 months (no change in weight +/- 3%)
  • Non-smoker
  • Able to walk comfortably on a treadmill

You may not qualify if:

  • Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
  • Waist circumference \< 94cm for male and \< 80cm for female
  • Taking medications that may influence lipid or carbohydrate metabolism or immune system function
  • Unable to take part in exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 9, 2016

First Posted

August 17, 2016

Study Start

July 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 17, 2016

Record last verified: 2016-08