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Search / Trial NCT06573749

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

Launched by LOUGHBOROUGH UNIVERSITY · Aug 23, 2024

Trial Information

Current as of June 28, 2025

Recruiting

Keywords

Nutrition Neuromuscular Milk Fat Globule Membrane

ClinConnect Summary

This clinical trial is investigating whether a supplement made from milk fat, called bioactive whey protein concentrate, can improve muscle function in healthy adults who are active. The study will last for 12 weeks and will compare the effects of this supplement to a placebo, which is a non-active treatment. Researchers are particularly interested in seeing if older adults benefit more from the supplement than younger adults. The goal is to find out if taking the milk fat supplement can help increase strength and power in muscles.

To be eligible for the trial, participants must be between 18 to 30 years old or 60 to 75 years old, and they should be healthy without any serious medical conditions that prevent them from exercising. Participants need to be recreationally active, meaning they should meet the government's guidelines for physical activity. Those who have certain health issues, recent injuries, or who take specific medications will not be able to participate. If you join the study, you can expect to take either the milk fat supplement or the placebo for three months and take part in assessments to measure any changes in your muscle function.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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)
  • Exclusion Criteria:
  • 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

About Loughborough University

Loughborough University is a leading UK higher education institution renowned for its commitment to research excellence and innovation in various fields, including health and sports sciences. As a clinical trial sponsor, the university leverages its extensive expertise and state-of-the-art facilities to design and conduct robust clinical studies aimed at advancing medical knowledge and improving patient outcomes. With a focus on interdisciplinary collaboration, Loughborough University fosters partnerships with industry and healthcare organizations, ensuring that its research initiatives are both impactful and aligned with real-world health challenges.

Locations

Loughborough, Leicestershire, United Kingdom

Patients applied

0 patients applied

Trial Officials

Edward Sadula, BSc, MSc

Principal Investigator

Loughborough University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported