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Status unknownNCT05496452Updated Apr 26, 2023

Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis

An interventional study of Beta-lactoglobulin and Carbohydrate in Muscle Atrophy, sponsored by King's College London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.

Sponsored by King's College London · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Muscle Atrophy

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03

In context

Muscular Atrophy

494 studies on the registry are indexed under Muscular Atrophy; 94 are open to participants now.

This study's planned enrollment of 24 is below the median of 33 across 335 interventional studies indexed under Muscular Atrophy.

Browse Muscular Atrophy studies →

Lead sponsor

King's College London is the lead sponsor of 507 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Beta-lactoglobulin

    Daily supplementation over 12 day period. A nutritional supplement.

    Dietary Supplement: Beta-lactoglobulin

  • Placebo comparator
    Carbohydrate

    Daily supplementation over 12 day period. Energy matched control.

    Dietary Supplement: Carbohydrate

Interventions

  • Dietary supplementBeta-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.

  • Dietary supplementCarbohydrate

    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.

06

What researchers measure

Primary outcomes

  1. Muscle protein synthesis

    The synthesis of amino acids into new muscle protein.

    Time frame: 15 days

Secondary outcomes

  1. Muscle mass

    Lean body mass will be measured using Dual Energy Xray Absorptiometry.

    Time frame: 15 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05496452
Lead sponsor
King's College London
Collaborators
University of Nottingham
Responsible party
Sponsor
First posted
Aug 11, 2022
Start date
Apr 1, 2023
Primary completion
Mar 1, 2024 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
Apr 26, 2023

Study contacts

Oliver C Witard, PhD
Contact
oliver.witard@kcl.ac.uk
02078484021 ext. 4071
Alix Hughes, MSc
Contact
alix.hughes@kcl.ac.uk
02078484022 ext. 4072
Oliver Witard, PhD
principal investigator · King's College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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