NCT05496452

Brief Summary

The objectives of this study are to:

  1. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

April 26, 2023

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

August 9, 2022

Last Update Submit

April 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis

    The synthesis of amino acids into new muscle protein.

    15 days

Secondary Outcomes (1)

  • Muscle mass

    15 days

Study Arms (2)

Beta-lactoglobulin

EXPERIMENTAL

Daily supplementation over 12 day period. A nutritional supplement.

Dietary Supplement: Beta-lactoglobulin

Carbohydrate

PLACEBO COMPARATOR

Daily supplementation over 12 day period. Energy matched control.

Dietary Supplement: Carbohydrate

Interventions

Beta-lactoglobulinDIETARY_SUPPLEMENT

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.

Beta-lactoglobulin
CarbohydrateDIETARY_SUPPLEMENT

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.

Carbohydrate

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

RECRUITING

Related Publications (1)

  • Hughes A, Francis T, Marjoram L, Rooney JH, Ellison-Hughes G, Pollock R, Curtis MJ, Cape A, Larsen M, Phillips BE, Atherton PJ, Smith K, Witard OC. The effect of combined beta-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trial. Trials. 2023 Jun 13;24(1):401. doi: 10.1186/s13063-023-07329-6.

MeSH Terms

Conditions

Muscular Atrophy

Interventions

LactoglobulinsCarbohydrates

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Whey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Officials

  • Oliver Witard, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver C Witard, PhD

CONTACT

Alix Hughes, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinded to supplement (beta-lactoglobulin or carbohydrate)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a double-blind, 2-arm, randomised placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

April 1, 2023

Primary Completion

March 1, 2024

Study Completion

August 1, 2024

Last Updated

April 26, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

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.

Locations