Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Atrophy
• Intervention / Treatment: Dietary supplement: Beta-lactoglobulin; Dietary supplement: Carbohydrate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oliver C Witard, PhD; Phone Number: 4071 02078484021; Email: oliver.witard@kcl.ac.uk
• Study Contact Backup: Name: Alix Hughes, MSc; Phone Number: 4072 02078484022; Email: alix.hughes@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • Recruiting
    • King's College London
    • Contact: Alix Hughes, MSc; Phone Number: 4072 02078484022; Email: alix.hughes@kcl.ac.uk
    • Contact: Oliver Witard, PhD; Phone Number: 07706587445; Email: oliver.witard@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beta-lactoglobulin; Daily supplementation over 12 day period. A nutritional supplement.	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.
Placebo Comparator: Carbohydrate; Daily supplementation over 12 day period. Energy matched control.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle protein synthesis	The synthesis of amino acids into new muscle protein.	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	Lean body mass will be measured using Dual Energy Xray Absorptiometry.	15 days

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: University of Nottingham
• Investigators: Principal Investigator: Oliver Witard, PhD, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy
• Other Study ID Numbers: BLGIMMPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be presented in form of peer reviewed manuscript. While individual data will be presented, these data will not be identifiable to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No