Effect of 12-week Milk Fat Globule Membrane Supplementation on the Human Muscle Function of Middle-aged Exercisers
NCT Number: NCT06573749
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ageing Well|Age-Related Atrophy|Age-Related Sarcopenia
Interventions: DIETARY_SUPPLEMENT: Bioactive whey protein concentrate|DIETARY_SUPPLEMENT: Pea-based protein supplement
Sponsor: Loughborough University
Collaborators: Volac International Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-14
Completion Date: 2025-07-14
Locations: Loughborough University, Loughborough, Leicestershire, LE11 3TU, United Kingdom

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.

Primary Outcome Measures: Maximal voluntary isometric torque of the knee extensors, Assessed during maximal voluntary contractions (Nm), 12 weeks
Secondary Outcome Measures: Rate of torque development of the knee extensors, Assessed during explosive isometric contractions (Nm/s), 12 weeks|Peak twitch torque (knee extensors), (Nm), 12 weeks|Time to peak twitch torque (knee extensors), (ms), 12 weeks|Half-relaxation time during twitch contractions (knee extensors), (ms), 12 weeks|Neural activation of the agonist (quadriceps) and antagonist (hamstrings), Surface electromyography (root mean square amplitude), 12 weeks|Force-frequency relationship of the knee extensors, Peak torque across the various stimulation frequencies (1 - 100 Hz, Nm), 12 weeks|Neuromuscular junction transmission stability, Extraction of variables (e.g. jitter and jiggle) from the decomposition of intramuscular electromyography signals recorded during submaximal (10 and 25% of maximal voluntary force) isometric knee extension contractions held for 20 seconds, 12 weeks|Cross-sectional area of upper leg muscles, Measured by MRI (cm\^2), 12 weeks|Volume of upper leg muscles, Measured by MRI (cm\^3), 12 weeks|Functional cross-sectional area of upper leg muscles, Measured by MRI (cm\^2), 12 weeks|Functional volume of upper leg muscles, Measured by MRI (cm\^3), 12 weeks|Intramuscular fat infiltration of upper leg muscles, Measured by MRI (% of intramuscular fat), 12 weeks|Neuromuscular power, Measured during countermovement jumps on a force plate (W), 12 weeks|Level of physical activity, International Physical Activity Questionnaire (IPAQ), 12 weeks|Habitual energy intake, Measured by food diary (kcal.day-1), 12 weeks|Habitual protein intake, Measured by food diary (g.day-1), 12 weeks|Habitual carbohydrate intake, Measured by food diary (g.day-1), 12 weeks|Habitual fibre intake, Measured by food diary (g.day-1), 12 weeks|Habitual fat intake, Measured by food diary (g.day-1), 12 weeks|Habitual choline intake, Measured by food diary (mg.day-1), 12 weeks