AzTrials
AzTrials

Ageing WellNCT06573749

Effect of 12-week Milk Fat Globule Membrane Supplementation on the Human Muscle Function of Healthy, Recreationally Active Adults

A study testing Bioactive whey protein concentrate and Whey protein isolate supplement in people with Ageing Well and Neuromuscular Function, run by Loughborough University at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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, recreationally active adults. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Ageing Well, Neuromuscular Function
What is being tested?
Bioactive whey protein concentrate and Whey protein isolate supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteUnited Kingdom
Study dates
28 Mar 2025to Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18-30 or 60-75 years old
  • Male or female
  • Healthy with no contraindications to exercise
  • Classified as recreationally active (meet the government's guidelines for weekly physical activity - 150 minutes of moderate physical activity or 75 minutes of vigorous physical activity)

Who cannot join

  • Any injury, medical condition or symptom precluding the ability to complete strenuous exercise as identified by the health screen questionnaire and physical activity readiness questionnaire
  • Uncontrolled hypertension (blood pressure of 140/90 mmHg or higher) as identified by recording resting blood pressure
  • Neuromuscular or musculoskeletal disease
  • Occurrence of a severe injury to the lower limbs or back within the previous 6 months (time loss of > 21 days of normal activity)
  • Occurrence of a minor injury to the lower limbs or back within the previous month (time loss of >1 day of normal activity)
  • Do not meet the government guidelines of minimum weekly physical activity as revealed by the IPAQ-SF
Show all 13Show fewer
  • Allergic to dairy or pea, or lactose intolerant
  • Complete greater than 6 hours structured exercise per week as revealed by the exercise and physical activity form
  • Consumption of supplements that may confound the results of the present study within the previous 3 months (includes any form of protein supplement, creatine, pre-workout supplements, any form of testosterone supplement, amino acids, beta-alanine, beta- hydroxy-beta-methylbutyrate (HMB), fish or krill oil, collagen supplements, any choline- containing supplement, or any phospholipid-containing supplement) as highlighted by the health screen questionnaire
  • Taking anticoagulants or antiplatelet drugs
  • Use of antidepressant/anti-anxiety medication
  • Having a blood borne virus, or a partner who has a blood-borne virus
  • Extreme diet classified as identified by the food-frequency questionnaire

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Edward Sadula, BSc, MSc contact

07477 866809

e.sadula2@lboro.ac.uk

Jonathan Folland, BSc, PhD contact

01509 226334

J.P.Folland@lboro.ac.uk

United Kingdom1 site, 1 recruiting
  • Loughborough University

    Loughborough, Leicestershire, LE11 3TU

    Jennifer Johnson, 1509 226769, j.j.johnson@lboro.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Effect of 12-week Bioactive Whey Protein Concentrate Supplementation on the Neuromuscular System of Healthy, Recreationally Active Adults

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, recreationally active adults. Furthermore, we aim to investigate whether any potential benefits of milk fat globule membrane are influenced by age through the assessment of 2 distinct age subgroups (young and older). 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, with a greater increase in the older group compared to the young group.

Read the detailed description

Nutritional strategies, including supplementation, are widely sought after to improve the function of the neuromuscular system (muscle strength and power). 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 improve muscle function 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 healthy, recreationally active adults.

This study aims to compare the effects of chronic (12 weeks) bioactive whey protein concentrate (BWPC) supplementation versus an isocaloric, isonitrogenous whey protein isolate placebo on the physiology (contractile properties, coactivation, timing of action potentials), morphology (total/functional muscle cross-sectional area/volume), and function of the neuromuscular system of healthy, recreationally active adults.

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 ~ 1.5 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 exercise/physical activity). Then they will attend two further post measurement sessions, with the first being at exactly 12 weeks of supplementation (i.e. 84th day) and the second being 3-4 days later (i.e. 87th or 88th day). The supplementation protocol will involve participants mixing 1 scoop of supplement 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 eat/drink 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 baseline/post will begin with countermovement jumps on a force plate. The remainder of the session will involve various isometric knee extension or flexion contractions within a custom-built isometric dynamometer. This will include maximal and explosive voluntary contractions to assess maximal strength of the knee extensors and flexors and rate of force development of the knee extensors, respectively. Supramaximal femoral nerve stimulation will be utilised to evoke twitch contractions of the knee extensors. Submaximal transcutaneous muscle stimulation will be performed to assess the force-frequency relationship (1 - 100 Hz) of the knee extensors. Finally, submaximal knee extension 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 surface EMG electrodes on each of the 3 superficial quadriceps muscles (rectus femoris, vastus lateralis and medialis) and on the hamstrings (medial and lateral).

Within the second measurement session at pre/post, participant's will have an 3.0 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.

For this study we want to assess whether any potential benefits of milk fat globule membrane are influenced by age. Therefore, we will be recruiting 2 subgroups (young 18 - 30 years old; older 60 - 75 years old). The power analysis was based on detecting a group by time interaction for isometric strength, with input parameters of: effect size = 0.15, alpha = 0.05, power = 0.8, correlation among repeated measures = 0.8. Altogether, 38 participants are needed as a minimum within each age group (19 per group). However, to account for a 25% drop-out rate, 48 participants will be recruited for each age group. The total number of participants recruited will be 96 (48 young, 48 older).

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.

Being tested
Bioactive whey protein concentrate, Whey protein isolate supplement
Keywords
Nutrition, Neuromuscular, Milk fat globule membrane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioactive whey protein concentrateDietary supplement

    Every day for 12 weeks, participants will mix 1 scoop of supplement with ~350ml of water and consume the resultant drink alongside their breakfast.

  • Whey protein isolate supplementDietary supplement

    Every day for 12 weeks, participants will mix 1 scoop of supplement with ~350ml of water and consume the resultant drink alongside their breakfast.

Study groups in NCT06573749
Study groupRoleWhat they receive
Bioactive whey protein concentrate supplement groupExperimentalThis group will consume a supplement called bioactive whey protein concentrate, a whey protein concentrate that contains milk fat globule membrane.
Receives: Dietary Supplement: Bioactive whey protein concentrate
Placebo groupPlacebo comparatorThis group will consume an isocaloric, isonitrogenous whey protein isolate supplement that does not contain phospholipids or sphingomyelin. Dextrose has been added to the whey protein isolate to ensure the 2 supplements are isocaloric.
Receives: Dietary Supplement: Whey protein isolate supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal voluntary isometric torque of the knee extensors

    Assessed during maximal voluntary contractions (Nm)

    Measured: 12 weeks

Secondary outcomes (21)
  1. Rate of torque development of the knee extensors

    Assessed during explosive isometric contractions (Nm/s)

    Measured: 12 weeks

  2. Peak twitch torque (knee extensors)

    (Nm)

    Measured: 12 weeks

  3. Time to peak twitch torque (knee extensors)

    (ms)

    Measured: 12 weeks

  4. Half-relaxation time during twitch contractions (knee extensors)

    (ms)

    Measured: 12 weeks

  5. Neural activation of the agonist (quadriceps) and antagonist (hamstrings)

    Surface electromyography (root mean square amplitude)

    Measured: 12 weeks

  6. Force-frequency relationship of the knee extensors

    Peak torque across the various stimulation frequencies (1 - 100 Hz, Nm)

    Measured: 12 weeks

  7. 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

    Measured: 12 weeks

  8. Cross-sectional area of upper leg muscles

    Measured by MRI (cm^2)

    Measured: 12 weeks

  9. Volume of upper leg muscles

    Measured by MRI (cm^3)

    Measured: 12 weeks

  10. Functional cross-sectional area of upper leg muscles

    Measured by MRI (cm^2)

    Measured: 12 weeks

  11. Functional volume of upper leg muscles

    Measured by MRI (cm^3)

    Measured: 12 weeks

  12. Intramuscular fat infiltration of upper leg muscles

    Measured by MRI (% of intramuscular fat)

    Measured: 12 weeks

  13. Neuromuscular power

    Measured during countermovement jumps on a force plate (W)

    Measured: 12 weeks

  14. Level of physical activity

    International Physical Activity Questionnaire (IPAQ)

    Measured: 12 weeks

  15. Habitual energy intake

    Measured by food diary (kcal.day-1)

    Measured: 12 weeks

  16. Habitual protein intake

    Measured by food diary (g.day-1)

    Measured: 12 weeks

  17. Habitual carbohydrate intake

    Measured by food diary (g.day-1)

    Measured: 12 weeks

  18. Habitual fibre intake

    Measured by food diary (g.day-1)

    Measured: 12 weeks

  19. Habitual fat intake

    Measured by food diary (g.day-1)

    Measured: 12 weeks

  20. Habitual choline intake

    Measured by food diary (mg.day-1)

    Measured: 12 weeks

  21. Maximum voluntary isometric torque of the knee flexors

    Assessed during maximal voluntary contractions (Nm)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start28 Mar 2025
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be allocated to one of two groups, placebo or bioactive whey protein concentrate supplement. Within each supplement group there will be 2 age subgroups (young and older).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06573749
Sponsor's protocol ID
16406
Status last verified
Mar 2025
First submitted
21 Aug 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bioactive whey protein concentrate and Whey protein isolate supplement in people with Ageing Well and Neuromuscular Function, run by Loughborough University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edward Sadula, BSc, MSc (07477 866809, e.sadula2@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal voluntary isometric torque of the knee extensors (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in