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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02624011
Other study ID # ERN_15-1238
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date February 2018

Study information

Verified date October 2018
Source University of Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Sarcopenia, the loss of muscle mass with age, is thought to be accelerated by an inactive, sedentary lifestyle. Increased sedentary time has consistently been associated with lower muscle mass and compromised metabolic health. However, there is currently a lack of direct evidence to support these associations.

Therefore, this study will investigate whether increased sedentary time (reduced step count and exercise cessation) directly influences long-term measures of muscle protein synthesis and metabolic health in young, active adults. Following a 7 day period of normal habitual physical activity, participants will undertake a 7 day period of step reduction and exercise cessation. It is hypothesised that 7 days of increased sedentary time will result in a reduction in long-term rates of muscle protein synthesis and a worsening of metabolic health.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date February 2018
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom School of Sport Exercise and Rehabilitation Sciences, University of Birmingham Birmingham

Sponsors (2)

Lead Sponsor Collaborator
University of Birmingham Maastricht University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Rate of fat oxidation at rest (g/min) Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of fat oxidation at rest (g/min). For 20 minutes at day 7 and day 14
Secondary Rate of fat oxidation during an oral glucose tolerance test (g/min) Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) following an oral glucose drink will be measured using indirect calorimetry to calculate the 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
Secondary Rate of carbohydrate oxidation at rest (g/min) Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation at rest (g/min). For 20 minutes at day 7 and day 14
Secondary Rate of carbohydrate oxidation during an oral glucose tolerance test (g/min) Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) following an oral glucose drink will be measured using indirect calorimetry to calculate the 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
Secondary Blood glucose concentration Blood glucose concentration will be assessed in blood samples taken during the oral glucose tolerance test. At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Secondary Blood insulin concentration Blood insulin concentration will be assessed in blood samples taken during the oral glucose tolerance test. At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Secondary Blood fatty acid concentration Blood fatty acid concentration will be assessed in blood samples taken during the oral glucose tolerance test. At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
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