CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Energy Balance +2 moredietary
Likely dose
Not stated in record
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Search/NCT05203133
NCT05203133N/ACompleted

Investigating the Combined Effect of Acute Energy Deficit and Aerobic Exercise Training on Muscle Quality in Healthy Adult Males

Liverpool John Moores University·interventional·Posted Jan 24, 2022·Updated Nov 9, 2022

In Brief

A clinical study evaluating Energy Balance, Energy Deficit, and 1 other intervention for Energy Supply; Deficiency and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

10 healthy, male, participants will complete a a 5-day baseline assessment (days -5 to -1) and two consecutive 5-day periods of controlled exercise to increase oxidative capacity (3 days of aerobic exercise per period, 15 kcal/kg FFM/day energy expenditure cycling) and energy intake (15 days in total, with a testing session on morning 16). This will achieve states of energy balance (EB; energy availability - EA - 45 kcal/kg of fat free mass (FFM)/day), required for weight maintenance (days 1 - 5), followed by energy deficit (ED; EA 10 kcal/kg FFM/day), required for weight loss on days 6 - 10. Over the data-collection period, participants will consume deuterium (D2O) tracer to facilitate dynamic proteomic profiling to assess the impact of the intervention on muscle quality (primary outcome measure). Muscle biopsies will therefore be collected on days -5, 1, 6 \& 11, alongside daily saliva samples, and venous blood collection on days -5, 1, 3, 5, 6, 8, 10 \& 11. These samples will be used to assess further, secondary, outcome measures including alterations in intra-muscular lipid profiles (lipid droplet content, morphology and lipid-droplet associated proteins in different subcellular compartments \[intermyofibrillar vs subsarcolemmal\]), alterations in blood metabolites and hormones and skeletal muscle glycogen concentrations. Changes in body mass, body composition and RMR will also be assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 24, 2022
Enrollment StartAug 23, 2021
Primary CompletionDec 15, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.4 years ago

Interventions

Energy Balancedietary

Energy balance phase to elicit weight-maintenance

Energy Deficitdietary

Energy deficit phase to elicit weight-loss

Baseline Assessmentdietary

Free-living assessment of energy status