Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000565943
Ethics application status
Approved
Date submitted
16/04/2020
Date registered
14/05/2020
Date last updated
6/03/2023
Date data sharing statement initially provided
14/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of long-term New Zealand green shell mussel powder consumption on promoting the recovery of muscle function following a bout of exercise-induced muscle damage to the quadriceps in untrained healthy males.
Scientific title
Investigating the effect of New Zealand green shell mussel powder consumption on recovery of musculo-skeletal performance and acute inflammation following exercise-induced muscle damage to the quadriceps in untrained healthy males
Secondary ID [1] 301018 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle damage 317084 0
Condition category
Condition code
Musculoskeletal 315249 315249 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, placebo controlled, parallel cross-over design intervention study that will allow us to evaluate whether long-term supplementation with New Zealand GSM promotes muscle recovery following eccentric exercise-induced muscle damage to the quadriceps. Prospective participants who have passed the study's inclusion/exclusion criteria will be asked to attend a familiarisation session (approximately 1 hr) where they will meet with the study’s principal investigator. During this session, the study’s trial coordinator (Research Associate, approx. 5 years experience in human studies) and principal investigator (Research Scientist, PhD) who will introduced them to the subjective visual analogue scale (VAS) and questionnaire for pain assessment that they will be asked to respond to during the trial days. Each participant’s quadriceps muscle function will be measured using a Biodex isokinetic dynamometer where they will be asked to perform three maximal concentric, eccentric and isometric contractions. Muscle function measures on quadriceps of both legs will be conducted. Participants will be also be familiarised to the bench stepping exercise that they will need to complete during the trial day. Participants will be required to step up (concentric) on a bench set at a height of 110% of their lower leg length then by step down (eccentric) from the bench with the contralateral leg at a speed of 15 cycles per minute for two minutes. During this exercise, participants will wear a weighted vest containing an additional mass corresponding to 15% of their bodyweight.

Participants will be required to undergo a six week washout period prior to starting the first arm of this study which can start one week of their familiarisation session. During these six weeks, they will be given a list of foods (e.g. mussel or mussel-derived food) to abstain from consuming. For the first arm of this study, recruited participants will be evenly randomised into two treatment groups: (1) New Zealand GSM group and (2) Placebo group. At the start of the study arm, the trial co-ordinator will then give participants gelatine capsules containing either the New Zealand GSM powder or the placebo. Participants will be instructed to consume 3 g of their treatment encapsulated intervention once daily for four weeks. The trial coordinator will meet with each participant weekly to track their compliance.

The day after their four-week supplementation period, participants will arrive at the research facility to complete their exercise trial day. They will initially undergo quadriceps muscle function assessments as previously described followed by subjective pain assessments (questionnaire and VAS scale). Following the muscle function assessment, participants will be required to complete their customised bench stepping exercise that they were familiarised to for 30 minutes at a frequency of 15 cycles per minute. The leg assigned to undergo eccentric muscle damage exercise, will be evenly distributed between the left and right leg for the study cohort but individually randomly determined. Immediately after the exercise, assessments of quadriceps muscle function of both legs and subjective pain will be conducted. At 24, 48 and 72 hours post exercise, participants will be required to return to the facility for muscle function and subjective pain assessments.

Similar to the first prior arm, participants will be required to under six weeks of washout during which they will undergo the same dietary restrictions. This can start as early as 1 week after the first trial arm. Following the washout period, participants will return for the second where they will the asked to consume the dietary intervention (placebo or GSM) that they did not receive during the first arm. Furthermore, participants will undergo the same muscle damage and recovery protocols with the contralateral leg to the one that had undergone eccentric muscle damage during the exercise trial day during the first trial arm.
Intervention code [1] 317344 0
Treatment: Other
Comparator / control treatment
A commercially sourced sunflower protein seed powder will be used as the placebo in this study. The placebo powder contains significantly lower protein, lipid and carbohydrates compared to the GSM powder. Given the very small quantities of treatment intervention consumed daily, 3 g of the placebo powder is not expected to significantly affect the daily micro or macro nutrient profile of participants. Both the GSM and placebo powders will be encapsulated in opaque gelatin capsules to blind both participants and trial investigators to which treatment is being administered.
Control group
Placebo

Outcomes
Primary outcome [1] 323498 0
Composite measures of muscle function parameters will include absolute and average peak torque from five maximal isometric, eccentric and concentric quadriceps contractions
Timepoint [1] 323498 0
These assessments will be conducted before and immediately after the bench-stepping exercise on exercise trial days. Muscle function will also be measured 24, 48 and 72 hours post exercise trial days.
Primary outcome [2] 323499 0
Composite biomarkers of inflammation - plasma concentrations of IL-4, IL-2, CXCL10 (IP-10), IL-1ß, TNF-a, CCL2 (MCP-1), IL-17A, IL-6, IL-10, IFN-gamma, IL-12p70, CXCL8 (IL-8), TGF-ß1 and RANTES
Timepoint [2] 323499 0
These biomarkers of muscle damage will be measured from blood samples collected before and immediately after the bench-stepping exercise on exercise trial days and at timepoints corresponding to 24, 48 and 72 hours post exercise. These parameter will be assayed using a bead-based multiplex panel and measured by flow cytometry. RANTES will be quantified using a commercially available kit.
Primary outcome [3] 323500 0
Composite biomarkers of muscle damage (creatine kinase activity and plasma C-reactive protein concentration) will be measured from plasma samples.
Timepoint [3] 323500 0
These biomarkers of muscle damage will be measured from blood samples collected before and immediately after the bench-stepping exercise on exercise trial days and at timepoints corresponding to 24, 48 and 72 hours post exercise. Creatine kinase activity will be measured by a commercial medical testing laboratory. C-reactive protein concentrations will be measured using a commercial assay kit.
Secondary outcome [1] 382060 0
Subjective measures of pain
Timepoint [1] 382060 0
Participants will be asked to complete a short-from McGill pain questionnaire and give a pain score from a visual analogue scale before and immediately after the bench-stepping exercise on exercise trial days. These same assessments for pain will also be measured 24, 48 and 72 hours post exercise prior to muscle function assessments.
Secondary outcome [2] 382061 0
Composite biochemical measures of oxidative stress and recovery (plasma oxidative capacity, malondialdehyde, protein carbonyls and lactate) will be measured from plasma or whole blood samples.
Timepoint [2] 382061 0
All markers of oxidative stress will be measured from blood samples collected before and immediately after the bench-stepping exercise on exercise trial days using commercial assay kits or assays developed in-house. In addition, these measures will also be measured in blood samples collected at 24, 48 and 72 hours post exercise. Lactate will be measured at these timepoints using a "point of care" biosensor from finger prick samples.
Secondary outcome [3] 382062 0
Composite measures of plasma/whole blood antioxidant activity (glutathione peroxidase and superoxide dismutase) will be measured from venous blood.
Timepoint [3] 382062 0
These biomarkers for antioxidant activity will be measured from venous blood collected before and immediately after the bench-stepping exercise on exercise trial days using a commercial assay kit and a validated in-house assay. In addition, these measures will also be measured in blood samples collected at 24, 48 and 72 hours post exercise.
Secondary outcome [4] 382063 0
Composite cell phenotyping of circulating blood leukocytes
Timepoint [4] 382063 0
White blood cells isolated from venous blood before and immediately exercised will be stained with fluorophore-conjugated antibodies and analysed by flow cytometry for white blood cell phenotyping (granulocytes, monocytes and lymphocytes). White blood cells from venous bloods collected at 24, 48 and 72 hours post exercise will also undergo the same analysis.
Secondary outcome [5] 382064 0
Untargeted multiomic analysis of plasma samples - exploratory outcome
Timepoint [5] 382064 0
Blood plasma samples collected before and immediately after the bench-stepping exercise on exercise trial days and at timepoints corresponding to 24, 48 and 72 hours post exercise will undergo untargeted multiomic (metabolomics and lipidomics) analysis using validated LC-MS techniques.

Eligibility
Key inclusion criteria
Healthy males who are not involved in any comprehensive exercise training regime and can complete the physical requirements of the exercises (determined from the familiarisation day) will be selected for this study. Participants will be required to complete a health questionnaire and provide written consent for this study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are unwilling or unable to provide informed written consent or comply with the study procedures. Participants will also be excluded if they (i) have known hypersensitivity or intolerance to GSM, molluscs, crustaceans or food derived from these sources, (ii) have health conditions that impair their ability to perform the exercises or may be aggravated by the exercises in this study (e.g. injury, hernia, back or joint pain, cardiovascular and breathing problems), (iii) have a Sports Index score of 4.5 or greater as assessed by a Baecke habitual physical activity questionnaire and (iv) are unable to perform the exercises to the standard required by the trial coordinator during the familiarisation session.

In addition, participants will also be excluded if they have the following health conditions: (i) blood borne diseases (e.g. hepatitis), (ii) clinically diagnosed high/low blood pressure, (iii) recent bacterial or viral illness or (iv) are taking medication that affects the properties of blood (e.g. blood clotting).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a double-blind, placebo controlled, cross-over design intervention study consisting of two treatment interventions. In the first arm of this study, participants will be randomly allocated evenly to into the two treatment groups (GSM and placebo). The randomisation participants will be undertaken by a fellow scientist not involved in this study using a computer randomisation function. In the second arm of the study, participants will then be assigned the treatment intervention that they did not receive in the first arm. All recruited participants will then be allocated a random participant code (consisting of numerical and alphabetical characters) containing no information on which order of treatment participants were allocated to. To conceal the treatment allocation from the study investigators, those preparing and packaging the treatment interventions for the participants will not be involved in any other component of the study. Further, the treatment interventions will be encapsulated in opaque gelatin capsules to visually conceal the identity of the interventions to the volunteers and study investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a double-blind, placebo controlled, parallel crossover study. Participants will be evenly randomly allocated into two nutrition treatment groups: GSM and placebo. The computerised randomisation of participant treatment allocation for each participant will be undertaken by a fellow scientist not involved in this study using the randomisation function in Microsoft Excel.. Participant treatment allocation is held and concealed until completion of the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be expressed as mean +/- standard error. Interaction between GSM supplementation and muscle function following exercise damage and during recovery will be determined. Likewise, interaction between GSM and their effects on plasma cytokines, biomarkers of muscle damage, oxidative stress, subjective measures of pain and white blood cell counts following muscle damage and during recovery will also be determined. Statistical significance for the comparison between GSM and placebo groups will be assessed using paired t-tests. Multiple comparisons will be assessed by two-way ANOVA. Furthermore, multivariate analysis (like Principal Component Analysis) of multiomic data from plasma samples will be conducted to identify interactions between metabolites with physiological, subjective and biological parameters previously described. Where appropriate, the original data will be transformed to achieve normality and constant variance in the residuals. Statistical significance for all parameters will be set at P < 0.05 with a confidence level of 95%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2020
Actual
26/10/2020
Date of last participant enrolment
Anticipated
1/03/2021
Actual
4/02/2021
Date of last data collection
Anticipated
15/12/2021
Actual
5/08/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 22496 0
New Zealand
State/province [1] 22496 0
Manawatu

Funding & Sponsors
Funding source category [1] 305462 0
Government body
Name [1] 305462 0
Ministry of Business Innovation and Employment
Country [1] 305462 0
New Zealand
Funding source category [2] 305486 0
Commercial sector/Industry
Name [2] 305486 0
Sanford Limited
Country [2] 305486 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jocelyn Eason
Address
The New Zealand Institute for Plant & Food Research
Batchelar Road
Fitzherbert
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 305884 0
None
Name [1] 305884 0
Address [1] 305884 0
Country [1] 305884 0
Other collaborator category [1] 281289 0
Individual
Name [1] 281289 0
Dr Matt Barnes
Address [1] 281289 0
Massey University
School of Sport, Exercise & Nutrition
Tennent Drive
Palmerston North, 4474
Country [1] 281289 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305777 0
Health and Disability Ethics Committees
Ethics committee address [1] 305777 0
Ethics committee country [1] 305777 0
New Zealand
Date submitted for ethics approval [1] 305777 0
11/05/2020
Approval date [1] 305777 0
14/07/2020
Ethics approval number [1] 305777 0
20/STH/75

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101562 0
Dr Dominic Lomiwes
Address 101562 0
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 101562 0
New Zealand
Phone 101562 0
+64 6 355 6113
Fax 101562 0
+64 6 351 7050
Email 101562 0
[email protected]
Contact person for public queries
Name 101563 0
Pramod Gopal
Address 101563 0
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 101563 0
New Zealand
Phone 101563 0
+64 6 953 7678
Fax 101563 0
+64 6 351 7050
Email 101563 0
[email protected]
Contact person for scientific queries
Name 101564 0
Dominic Lomiwes
Address 101564 0
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 101564 0
New Zealand
Phone 101564 0
+64 6 355 6113
Fax 101564 0
+64 6 351 7050
Email 101564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This work is partly industry funded and publicly disclosing individual participant data will violate our confidentiality agreement to protect the intellectual property generated from this study.
Furthermore, ethics guidelines for human clinical studies do not allow us to release data that may risk the disclosure of the identity of participants who took part in this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Efficacy of New Zealand GreenshellTM Mussel Powder Supplementation in Supporting Muscle Recovery Following Eccentric Exercise-Induced Muscle Damage in Healthy, Untrained Adult Males.2023https://dx.doi.org/10.3390/nu15102316
N.B. These documents automatically identified may not have been verified by the study sponsor.