Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis

NCT ID: NCT05496452

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Muscle Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a double-blind, 2-arm, randomised placebo-controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Double blinded to supplement (beta-lactoglobulin or carbohydrate)

Study Groups

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Beta-lactoglobulin

Daily supplementation over 12 day period. A nutritional supplement.

Group Type EXPERIMENTAL

Beta-lactoglobulin

Intervention Type DIETARY_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.

Carbohydrate

Daily supplementation over 12 day period. Energy matched control.

Group Type PLACEBO_COMPARATOR

Carbohydrate

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Witard, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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King's College London

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Oliver C Witard, PhD

Role: CONTACT

02078484021 ext. 4071

Alix Hughes, MSc

Role: CONTACT

02078484022 ext. 4072

Facility Contacts

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Oliver Witard, PhD

Role: primary

07706587445

Alix Hughes, MSc

Role: backup

02078484022 ext. 4072

References

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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.

Reference Type DERIVED
PMID: 37312095 (View on PubMed)

Other Identifiers

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BLGIMMPS

Identifier Type: -

Identifier Source: org_study_id

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