NCT02624011

Brief Summary

This study will investigate the influence of increased sedentary time on long-term measures of muscle protein synthesis and metabolic health. The investigators will test the hypothesis that increased time spent in sedentary behaviours will lead to a reduction in long-term measures of muscle protein synthesis and compromised metabolic health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

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

First Submitted

Initial submission to the registry

December 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

December 2, 2015

Last Update Submit

October 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis (FSR %/day)

    Long-term muscle protein synthesis (FSR %/day) will be determined using deuterium oxide (D2O) to compare muscle protein synthesis rates over the first 7 day period and the second 7 day period.

    0-14 days

Secondary Outcomes (7)

  • Rate of fat oxidation at rest (g/min)

    For 20 minutes at day 7 and day 14

  • Rate of fat oxidation during an oral glucose tolerance test (g/min)

    At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14

  • Rate of carbohydrate oxidation at rest (g/min)

    For 20 minutes at day 7 and day 14

  • Rate of carbohydrate oxidation during an oral glucose tolerance test (g/min)

    At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14

  • Blood glucose concentration

    At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14

  • +2 more secondary outcomes

Study Arms (1)

Physical inactivity

EXPERIMENTAL

Study arm consisting of 7 days of habitual physical activity followed by 7 days of step reduction and exercise cessation.

Behavioral: 7 days of habitual physical activity followed by 7 days of reduced physical activity

Interventions

Young, active participants will undergo a 7 day period of habitual physical activity followed by a 7 day period of step reduction and exercise cessation.

Physical inactivity

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (18.5-29.99 kg/m2)
  • Active - defined as: ≥ 7000 steps per day (assessed during screening) and taking part in regular exercise (defined as participation in ≥ 3 sessions of aerobic and/or resistance exercise type sessions a week for ≥ 6 months prior to recruitment)
  • Good general health

You may not qualify if:

  • Lidocaine allergy
  • Hypertension (≥140/90 mmHg)
  • Current participation in another clinical study
  • Previous participation in this study
  • Bleeding disorder/s
  • Current or recent smoker
  • Past history of substance abuse and/or taking prescription or non-prescription medication (e.g., beta-blockers, insulin or thyroxine) or supplements that may influence normal metabolic responses.
  • Participants who have previously (within 5 years of the present study) had 4 or more muscle biopsies obtained from the thigh quadriceps region will be ineligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sport Exercise and Rehabilitation Sciences, University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Brandon J Shad, BSc

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 8, 2015

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Study Completion

February 1, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations