Muscle AtrophyNCT05496452
Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis
A study testing Beta-lactoglobulin and Carbohydrate in people with Muscle Atrophy, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy
- What is being tested?
- Beta-lactoglobulin and Carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE1 9NH
Oliver Witard, PhD, 07706587445, oliver.witard@kcl.ac.uk
Alix Hughes, MSc, 02078484022 ext. 4072, alix.hughes@kcl.ac.uk
About this study
Official title: Effect of Beta-lactoglobulin Supplementation on the Response of Muscle Protein Synthesis During Limb Immobilisation in Healthy Young Adults
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.
Read the 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.
- Conditions
- Muscle Atrophy
- Being tested
- Beta-lactoglobulin, Carbohydrate
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Beta-lactoglobulin | Experimental | Daily supplementation over 12 day period. A nutritional supplement. Receives: Dietary Supplement: Beta-lactoglobulin |
| Carbohydrate | Placebo comparator | Daily supplementation over 12 day period. Energy matched control. Receives: Dietary Supplement: Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
The synthesis of amino acids into new muscle protein.
Measured: 15 days
Secondary outcomes (1)
Muscle mass
Lean body mass will be measured using Dual Energy Xray Absorptiometry.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Apr 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a double-blind, 2-arm, randomised placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Oliver Witard, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496452
- Sponsor's protocol ID
- BLGIMMPS
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37312095
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beta-lactoglobulin Supplementation on the Response of Muscle Protein Synthesis During Limb Immobilisation in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT05496452
- Acronym / sponsor ID
- BLGIMMPS
- Conditions
- Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is a double-blind, 2-arm, randomised placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Beta-lactoglobulin | Experimental | Dietary Supplement: Beta-lactoglobulinDaily supplementation over 12 day period. A nutritional supplement. |
| Carbohydrate | Placebo comparator | Dietary Supplement: CarbohydrateDaily supplementation over 12 day period. Energy matched control. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-lactoglobulinBeta-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 supplement | Beta-lactoglobulin |
| CarbohydrateCarbohydrate (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. | Dietary supplement | Carbohydrate |
Primary outcome
Muscle protein synthesis
Time frame: 15 days
The synthesis of amino acids into new muscle protein.
1 secondary outcome
Muscle mass
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Derived from this study: PubMed 37312095Hughes 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Witard, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-lactoglobulin and Carbohydrate in people with Muscle Atrophy, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver C Witard, PhD (02078484021 ext. 4071, oliver.witard@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein synthesis (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05496452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.