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

NCT06573749 | Recruiting

• 1 other identifier: 16406
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Ageing Well; Neuromuscular Function

Keywords

Nutrition; Neuromuscular; Milk fat globule membrane

Outcome Measures

Primary Outcomes (1)

• Maximal voluntary isometric torque of the knee extensors

  Assessed during maximal voluntary contractions (Nm)

  12 weeks

Secondary Outcomes (21)

• Rate of torque development of the knee extensors

  12 weeks

• Peak twitch torque (knee extensors)

  12 weeks

• Time to peak twitch torque (knee extensors)

  12 weeks

• Half-relaxation time during twitch contractions (knee extensors)

  12 weeks

• Neural activation of the agonist (quadriceps) and antagonist (hamstrings)

  12 weeks

Study Arms (2)

Bioactive whey protein concentrate supplement group

EXPERIMENTAL

This group will consume a supplement called bioactive whey protein concentrate, a whey protein concentrate that contains milk fat globule membrane.

Dietary Supplement: Bioactive whey protein concentrate

Placebo group

PLACEBO COMPARATOR

This 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.

Dietary Supplement: Whey protein isolate supplement

Interventions

Bioactive whey protein concentrate DIETARY_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.

Bioactive whey protein concentrate supplement group

Whey protein isolate supplement DIETARY_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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Loughborough University: lead
• Volac International Limited: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

RECRUITING

Study Officials

• Edward Sadula, BSc, MSc

  Loughborough University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The placebo and bioactive whey protein concentrate supplement have been given specific codes by an external investigator to ensure that the participant and investigator are blinded. The external investigator will reveal which code corresponds to which supplement group once the principal investigator has completed statistical analysis.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher

Model Details: 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).

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 27, 2024
• Study Start: March 28, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)