Clinical trial NCT05496452: Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis
Official title: Effect of Beta-lactoglobulin Supplementation on the Response of Muscle Protein Synthesis During Limb Immobilisation in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Atrophy
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Nottingham
First posted: 2022-08-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a double-blind, 2-arm, randomised placebo-controlled trial
Primary purpose: PREVENTION

Brief summary: The objectives of this study are to:

1. Establish whether combined β-lactoglobulin supplementation and resistance training for 1 week prior to 5 days of limb immobilisation will attenuate the decrease in integrated free-living rates of MPS during short-term muscle disuse.
2. Establish whether combined β-lactoglobulin supplementation and resistance training for 1 week prior to limb immobilisation will attenuate the decrease in muscle mass and strength during short-term muscle disuse.

Detailed description: The objectives of this study are to:

1. Establish whether combined β-lactoglobulin supplementation and resistance training for 1 week prior to 5 days of limb immobilisation will attenuate the decrease in integrated free-living rates of MPS during short-term muscle disuse.
2. Establish whether combined β-lactoglobulin supplementation and resistance training for 1 week prior to limb immobilisation will attenuate the decrease in muscle mass and strength during short-term muscle disuse.

Hypotheses

1. Combining β-lactoglobulin and resistance training for 1 wk prior to 5 d of limb immobilisation will attenuate the decrease in integrated muscle protein synthesis, muscle fibre CSA, quadriceps muscle strength, and leg lean mass during muscle disuse.
2. Combining β-lactoglobulin and resistance training for 1 wk prior to 5 d of limb immobilisation will attenuate the decrease in muscle fibre CSA, quadriceps muscle strength, and leg lean mass during muscle disuse.

Eligibility criteria: Inclusion Criteria:

* Male and female
* Aged 18-45 years
* Healthy
* Physically active (≥150-300 minutes of moderate-intensity aerobic physical activity per week OR 75-150 minutes of vigorous-intensity aerobic physical activity per week)
* Eumenorrheic and not taking any hormonal birth control (females)

Exclusion Criteria:

* Dairy allergy or intolerance
* Lower limb injury or surgery in the last 6 months,
* Lower limb osteoarthritis or other musculoskeletal disorder
* A musculoskeletal or blood blotting disorder
* An allergy to local anaesthetic
* Currently pregnant
* Current use of blood thinning medications
* Volunteers that take part in structured resistance exercise training
* Taking supplements considered to be anabolic to skeletal muscle (protein supplements, creatine, or omega-3 supplements)
* Consuming more than 1.2 grams of protein per kilogram of body mass per day in their habitual diet.
* Volunteers involved in other studies at the time of enrolment
* Volunteers who have taken part in a tracer study in the past 18 months
* If without an understanding of verbal or written English
* Volunteers with a history of eating disorders

Primary outcomes:
measure: Muscle protein synthesis
timeFrame: 15 days
Secondary outcomes:
measure: Muscle mass
timeFrame: 15 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Oliver Witard, PhD
role: PRINCIPAL_INVESTIGATOR
References: