Effects of milk fat globule membrane supplementation on muscle function in active adults
Effect of 12-week Bioactive Whey Protein Concentrate Supplementation on the Neuromuscular System of Healthy, Recreationally Active Adults
NA · Loughborough University · NCT06573749
This study is testing if a special milk protein can help active adults improve their muscle strength and power over 12 weeks compared to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Loughborough University (other) |
| Locations | 1 site (Loughborough, Leicestershire) |
| Trial ID | NCT06573749 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a 12-week supplementation of a milk fat globule membrane-containing product, known as bioactive whey protein concentrate, can enhance muscle function compared to a placebo in healthy, recreationally active adults. Participants will be divided into two groups, one receiving the active supplement and the other receiving a placebo, with assessments of muscle strength and power conducted before and after the intervention. The study also aims to explore potential differences in outcomes between younger and older adults. By utilizing a randomized, double-blind, parallel group design, the research seeks to provide robust evidence regarding the efficacy of this nutritional strategy.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-30 or 60-75 who are recreationally active and meet physical activity guidelines.
Not a fit: Patients with neuromuscular or musculoskeletal diseases, or those with recent injuries that limit exercise, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved muscle function and strength in older adults, enhancing their quality of life and physical performance.
How similar studies have performed: While previous studies on milk fat globule membrane supplementation have shown promise, this specific approach is novel and aims to address methodological limitations of earlier research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Loughborough, Leicestershire
- Loughborough University — Loughborough, Leicestershire, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Edward Sadula, BSc, MSc — Loughborough University
- Study coordinator: Edward Sadula, BSc, MSc
- Email: e.sadula2@lboro.ac.uk
- Phone: 07477 866809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ageing Well, Neuromuscular Function, Nutrition, Neuromuscular, Milk fat globule membrane