Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573749
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Effect of 12-week Milk Fat Globule Membrane Supplementation on the Human Muscle Function of Middle-aged Exercisers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of 12-week Bioactive Whey Protein Concentrate Supplementation on the Neuromuscular System of Middle-aged Exercisers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim of this study is to understand if chronic supplementation 12 weeks of a milk fat globule membrane containing supplement called bioactive whey protein concentrate improves human muscle function greater than a placebo supplement within a cohort of healthy middle-aged exercisers We hypothesise that neuromuscular function strength and power will increase from pre to post within the group that consumes bioactive whey protein concentrate but not the placebo group
Detailed Description:
Nutritional strategies including supplementation are widely sought after to improve the function of the neuromuscular system which would be beneficial for ageing exercisers to maintain their ability to complete physical activities Milk fat globule membrane MFGM composed of the membrane that surrounds milk fat droplets has begun to receive increasing attention as a potential supplement to mitigate the age-related decline in muscle strength and size due to a series of promising longitudinal studies 4 weeks of supplementation however the overall findings are still conflicting which is likely due to methodological limitations of previous studies Therefore it is important to thoroughly investigate whether chronic supplementation of a MFGM-containing supplement is effective at improving the function and physiology of the neuromuscular system within middle-aged exercisers and masters athletes
This study aims to compare the effects of chronic 12 weeks bioactive whey protein concentrate BWPC supplementation versus an isocaloric isonitrogenous pea-based protein placebo on the physiology contractile properties coactivation timing of action potentials morphology totalfunctional muscle cross-sectional areavolume and function of the neuromuscular system of middle-aged exercisersmasters athletes
Utilising a randomised double-blind parallel group study design participants will be allocated to one of two groups BWPC or placebo supplement group Once consented participants will complete screening questionnaires to confirm their eligibility Altogether participants will be required to attend 5 laboratory sessions 1 familiarisation 25 hours 4 main measurement sessions each 2 hours at the neuromuscular laboratories situated within the Matthew Arnold building at Loughborough University The familiarisation and first two baseline measurement sessions will be done over a 2-week period after which participants will be asked to consume a supplement daily for 12 weeks 84 daily doses while they maintain their usual lifestyle diet and exercisephysical activity Then they will attend two further post measurement sessions with the first being at exactly 12 weeks of supplementation ie 84th day and the second being 3-4 days later ie 87th or 88th day The supplementation protocol will involve participants mixing 1 pre-packaged sachet with water and consuming the resultant drink alongside their breakfast Participants will be required to fill in a diet record form twice across the supplementation period week 3 and 9 which involves weighing and recording what they eatdrink over 3 consecutive days Physical activity at pre and post will be assessed through the International Physical Activity Questionnaire IPAQ short format
During the familiarisation session participants will get to try all of the types of contractions voluntary and involuntary to be performed in the main measurement sessions but without the recording of electromyography EMG The first measurement session at baselinepost will involve various isometric knee extension contractions within a custom-built isometric dynamometer This will include maximal and explosive voluntary contractions to assess maximal strength and rate of force development respectively Supramaximal femoral nerve stimulation will be utilised to evoke twitch contractions Submaximal transcutaneous muscle stimulation will be performed to assess the force-frequency relationship 1 - 100 Hz of the knee extensors Finally submaximal isometric contractions 10 and 25 of maximal voluntary force will be performed while a concentric needle electrode is inserted into the vastus lateralis to assess the stability of neuromuscular junction transmission Throughout this measurement session surface EMG signals will be collected by placing 2 surface EMG electrodes on each of the 3 superficial quadriceps muscles Rectus Femoris Vastus Lateralis and Medialis
Within the second measurement session at prepost participants will have an 30 T MRI scan of the lower limbs The procedure will be clearly explained to the participant before they sign the MRI agreement form and fill in the MRI safety questionnaire Following the scan participants will complete countermovement jumps on a force plate to assess neuromuscular power
The power analysis was based on detecting a group by time interaction for isometric strength with input parameters of effect size 01 alpha 005 power 095 correlation among repeated measures 095 Altogether 36 participants are needed as a minimum 18 per group However to account for a 30 drop-out rate 48 participants will be recruited for this study
Statistical analysis will involve fitting linear mixed effect models to detect any main effects or interactions with supplement group time pre vs post and their interaction as fixed effects and participant as a random intercept Visual plots histograms and quantile-quantile plots will be used to verify the assumptions of normality linearity and homoscedasticity of residuals
This study aims to compare the effects of chronic 12 weeks bioactive whey protein concentrate BWPC supplementation versus an isocaloric isonitrogenous pea-based protein placebo on the physiology contractile properties coactivation timing of action potentials morphology totalfunctional muscle cross-sectional areavolume and function of the neuromuscular system of middle-aged exercisersmasters athletes
Utilising a randomised double-blind parallel group study design participants will be allocated to one of two groups BWPC or placebo supplement group Once consented participants will complete screening questionnaires to confirm their eligibility Altogether participants will be required to attend 5 laboratory sessions 1 familiarisation 25 hours 4 main measurement sessions each 2 hours at the neuromuscular laboratories situated within the Matthew Arnold building at Loughborough University The familiarisation and first two baseline measurement sessions will be done over a 2-week period after which participants will be asked to consume a supplement daily for 12 weeks 84 daily doses while they maintain their usual lifestyle diet and exercisephysical activity Then they will attend two further post measurement sessions with the first being at exactly 12 weeks of supplementation ie 84th day and the second being 3-4 days later ie 87th or 88th day The supplementation protocol will involve participants mixing 1 pre-packaged sachet with water and consuming the resultant drink alongside their breakfast Participants will be required to fill in a diet record form twice across the supplementation period week 3 and 9 which involves weighing and recording what they eatdrink over 3 consecutive days Physical activity at pre and post will be assessed through the International Physical Activity Questionnaire IPAQ short format
During the familiarisation session participants will get to try all of the types of contractions voluntary and involuntary to be performed in the main measurement sessions but without the recording of electromyography EMG The first measurement session at baselinepost will involve various isometric knee extension contractions within a custom-built isometric dynamometer This will include maximal and explosive voluntary contractions to assess maximal strength and rate of force development respectively Supramaximal femoral nerve stimulation will be utilised to evoke twitch contractions Submaximal transcutaneous muscle stimulation will be performed to assess the force-frequency relationship 1 - 100 Hz of the knee extensors Finally submaximal isometric contractions 10 and 25 of maximal voluntary force will be performed while a concentric needle electrode is inserted into the vastus lateralis to assess the stability of neuromuscular junction transmission Throughout this measurement session surface EMG signals will be collected by placing 2 surface EMG electrodes on each of the 3 superficial quadriceps muscles Rectus Femoris Vastus Lateralis and Medialis
Within the second measurement session at prepost participants will have an 30 T MRI scan of the lower limbs The procedure will be clearly explained to the participant before they sign the MRI agreement form and fill in the MRI safety questionnaire Following the scan participants will complete countermovement jumps on a force plate to assess neuromuscular power
The power analysis was based on detecting a group by time interaction for isometric strength with input parameters of effect size 01 alpha 005 power 095 correlation among repeated measures 095 Altogether 36 participants are needed as a minimum 18 per group However to account for a 30 drop-out rate 48 participants will be recruited for this study
Statistical analysis will involve fitting linear mixed effect models to detect any main effects or interactions with supplement group time pre vs post and their interaction as fixed effects and participant as a random intercept Visual plots histograms and quantile-quantile plots will be used to verify the assumptions of normality linearity and homoscedasticity of residuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None