Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis

Muscle Atrophy Clinical Trial

Official title:

Effect of Beta-lactoglobulin Supplementation on the Response of Muscle Protein Synthesis During Limb Immobilisation in Healthy Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496452
• Other study ID #: BLGIMMPS
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2022
• Source: King's College London
• Contact: Oliver C Witard, PhD
• Phone: 02078484021
• Email: oliver.witard[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Atrophy
• Muscular Atrophy

Intervention

Dietary Supplement:
• Beta-lactoglobulin
Beta-lactoglobulin (BLG) will be administered thrice daily during a 7 day period of prehabilitation and 5 day period of immobilisation when the leg is placed in a brace.
• Carbohydrate
Carbohydrate (dextrose monohydrate) will be administered thrice daily during a 7 day period of prehabilitation and 5 day period of immobilisation when the leg is placed in a brace.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle protein synthesis	The synthesis of amino acids into new muscle protein.	15 days
Secondary	Muscle mass	Lean body mass will be measured using Dual Energy Xray Absorptiometry.	15 days