Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis
Primary Purpose
Muscle Atrophy
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Beta-lactoglobulin
Carbohydrate
Sponsored by
About this trial
This is an interventional prevention trial for Muscle Atrophy
Eligibility Criteria
Inclusion Criteria:
Male and female (equal numbers per group) 18 - 35 years old Recreationally active; taking part in 1 - 3 hours of structured physical activity per week Eumenorrheic females, who have not taken a form of hormonal contraception in at least 1 year
Exclusion Criteria:
Dairy intolerance. Consuming any other nutritional supplement. Participation in another research study.
Sites / Locations
- King's College LondonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Beta-lactoglobulin
Carbohydrate
Arm Description
Daily supplementation over 12 day period. A nutritional supplement.
Daily supplementation over 12 day period. Energy matched control.
Outcomes
Primary Outcome Measures
Muscle protein synthesis
The synthesis of amino acids into new muscle protein.
Secondary Outcome Measures
Muscle mass
Lean body mass will be measured using Dual Energy Xray Absorptiometry.
Full Information
NCT ID
NCT05496452
First Posted
August 9, 2022
Last Updated
April 24, 2023
Sponsor
King's College London
Collaborators
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT05496452
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study are to:
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.
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:
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.
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a double-blind, 2-arm, randomised placebo-controlled trial
Masking
ParticipantInvestigator
Masking Description
Double blinded to supplement (beta-lactoglobulin or carbohydrate)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Beta-lactoglobulin
Arm Type
Experimental
Arm Description
Daily supplementation over 12 day period. A nutritional supplement.
Arm Title
Carbohydrate
Arm Type
Placebo Comparator
Arm Description
Daily supplementation over 12 day period. Energy matched control.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-lactoglobulin
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle protein synthesis
Description
The synthesis of amino acids into new muscle protein.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Muscle mass
Description
Lean body mass will be measured using Dual Energy Xray Absorptiometry.
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver C Witard, PhD
Phone
02078484021
Ext
4071
Email
oliver.witard@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alix Hughes, MSc
Phone
02078484022
Ext
4072
Email
alix.hughes@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Witard, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Witard, PhD
Phone
07706587445
Email
oliver.witard@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Alix Hughes, MSc
Phone
02078484022
Ext
4072
Email
alix.hughes@kcl.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis
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