Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID06573749

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

Led by Loughborough University · Updated on 2025-04-02

96

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

L

Loughborough University

Lead Sponsor

V

Volac International Limited

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring whether a 12-week daily supplement containing milk fat globule membrane, called bioactive whey protein concentrate, can improve muscle strength and power more than a placebo in healthy, recreationally active adults. The study also aims to understand if these effects differ between younger adults (18-30 years) and older adults (60-75 years). This trial uses a randomized, double-blind design to assess neuromuscular function, morphology, and physiology in these age groups. Participants will be assigned to consume either the bioactive whey protein concentrate supplement or an isocaloric, isonitrogenous whey protein isolate placebo daily for 12 weeks, mixing one scoop with water and taking it with breakfast. The study includes a 2-week baseline period with familiarization and pre-measurements followed by the 12-week supplementation and then two post-supplementation measurement sessions within days 84 to 88. Both supplements are matched for calories and protein content but differ in milk fat globule membrane content. Participants will attend five laboratory sessions, including familiarization, baseline, and post-supplementation assessments involving various muscle function tests using force plates, dynamometers, nerve stimulation, and electromyography. MRI scans of the lower limbs will measure muscle size and composition. Dietary intake and physical activity will be tracked during the study. The main outcome is maximal voluntary isometric torque of the knee extensors after 12 weeks, with several secondary measures of muscle performance, activation, and morphology also assessed. The total study duration per participant is approximately 14 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 18 and 30 years old or between 60 and 75 years old
  • Be male or female
  • Be healthy with no contraindications to exercise
  • Be recreationally active, meeting government guidelines for weekly physical activity (at least 150 minutes of moderate or 75 minutes of vigorous activity)
Not Eligible

You will not qualify if you...

  • Have any injury, medical condition, or symptom that prevents strenuous exercise
  • Have uncontrolled hypertension with blood pressure 140/90 mmHg or higher
  • Have neuromuscular or musculoskeletal disease
  • Have had a severe lower limb or back injury in the past 6 months causing more than 21 days of activity loss
  • Have had a minor lower limb or back injury in the past month causing more than 1 day of activity loss
  • Do not meet government physical activity guidelines as per IPAQ-SF
  • Be allergic to dairy or pea, or lactose intolerant
  • Complete more than 6 hours of structured exercise per week
  • Have taken supplements that may affect results in the past 3 months, including protein supplements, creatine, testosterone, amino acids, beta-alanine, HMB, fish or krill oil, collagen, choline-containing, or phospholipid-containing supplements
  • Be taking anticoagulants or antiplatelet drugs
  • Use antidepressant or anti-anxiety medication
  • Have a blood-borne virus or a partner with one
  • Follow an extreme diet as identified by the food-frequency questionnaire

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants complete screening questionnaires to confirm eligibility.

Baseline Measurement

Duration - 2 weeks

Participants attend 3 laboratory sessions over 2 weeks to complete familiarisation and baseline neuromuscular assessments including muscle contractions, EMG recordings, and MRI scans.

5 laboratory sessions: 1 familiarisation (~1.5 hours) and 4 measurement sessions (~2 hours each).

Treatment

Duration - 12 weeks

Participants consume a daily supplement (bioactive whey protein concentrate or placebo) for 12 weeks while maintaining their usual lifestyle.

Daily supplement intake; diet record forms completed twice during this period.

Post-treatment Measurement

Duration - 3 to 4 days

Participants attend two post-supplementation laboratory sessions to repeat neuromuscular assessments and MRI scans to evaluate changes after the 12-week supplementation.

2 visits at 12 weeks and 3-4 days later.

Trial Site Locations

Total: 1 location

1

Loughborough University

Loughborough, Leicestershire, United Kingdom, LE11 3TU

Actively Recruiting

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Research Team

E

Edward Sadula, BSc, MSc

J

Jonathan Folland, BSc, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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