Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis

Sponsor

King's College London (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05496452

Collaborator

University of Nottingham (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary aims of this study are:

To investigate the impact of β-lactoglobulin supplementation combined with resistance training on integrated rates of muscle protein synthesis, muscle fibre CSA, static markers of muscle protein breakdown, quadriceps muscle strength, and leg lean mass prior to 7-days of limb immobilisation.

To investigate the impact of β-lactoglobulin supplementation on integrated rates of muscle protein synthesis during 2 weeks of resistance training.

Condition or Disease	Intervention/Treatment	Phase
Muscle Atrophy	Dietary Supplement: Beta-lactoglobulin	N/A

Detailed Description

The primary aims of this study are:

To investigate the impact of β-lactoglobulin supplementation on integrated rates of muscle protein synthesis during 2 weeks of resistance training.

The secondary aims of this study are:

To investigate sex comparisons in the impact of β-lactoglobulin supplementation combined with resistance training on integrated rates of muscle protein synthesis, muscle fibre CSA, static markers of muscle protein breakdown, quadriceps muscle strength, and leg lean mass prior to 7-days of limb immobilisation.

Hypotheses

Combining β-lactoglobulin and resistance training for 2 wk prior to- and during 7 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 β-lactoglobulin supplementation will augment the resistance training-induced stimulation of integrated muscle protein synthesis and muscle fibre CSA to a greater extent than maltodextrin supplementation.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is a double-blind, 2-arm, randomised placebo-controlled trialThis study is a double-blind, 2-arm, randomised placebo-controlled trial

Masking:

Double (Participant, Investigator)

Masking Description:

Double blinded to supplement (beta-lactoglobulin or carbohydrate)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Beta-lactoglobulin Daily supplementation over 21 day period. A nutritional supplement.	Dietary Supplement: Beta-lactoglobulin Beta-lactoglobulin (BLG) is a novel milk protein that is rich in essential amino acids and leucine. Essential amino acids and leucine are key regulators of muscle protein synthesis. BLG will be administered thrive daily during a 14 day period of prehabilitation and 7 day period of immobilisation when the leg is placed in a cast.
Placebo Comparator: Carbohydrate Daily supplementation over 21 day period. Energy matched control.	Dietary Supplement: Beta-lactoglobulin Beta-lactoglobulin (BLG) is a novel milk protein that is rich in essential amino acids and leucine. Essential amino acids and leucine are key regulators of muscle protein synthesis. BLG will be administered thrive daily during a 14 day period of prehabilitation and 7 day period of immobilisation when the leg is placed in a cast.

Arm

Intervention/Treatment

Experimental: Beta-lactoglobulin

Daily supplementation over 21 day period. A nutritional supplement.

Dietary Supplement: Beta-lactoglobulin

Beta-lactoglobulin (BLG) is a novel milk protein that is rich in essential amino acids and leucine. Essential amino acids and leucine are key regulators of muscle protein synthesis. BLG will be administered thrive daily during a 14 day period of prehabilitation and 7 day period of immobilisation when the leg is placed in a cast.

Placebo Comparator: Carbohydrate

Daily supplementation over 21 day period. Energy matched control.

Dietary Supplement: Beta-lactoglobulin

Outcome Measures

Primary Outcome Measures

Muscle protein synthesis [24 months]
The synthesis of amino acids into new muscle protein.

Secondary Outcome Measures

Muscle mass [24 months]
Lean body mass will be measured using Dual Energy Xray Absorptiometry.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

King's College London
University of Nottingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

King's College London

ClinicalTrials.gov Identifier:

NCT05496452

Other Study ID Numbers:

BLGIMMPS

First Posted:

Aug 11, 2022

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Muscular Atrophy

Study Results

No Results Posted as of Aug 11, 2022