Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000303640p
Ethics application status
Submitted, not yet approved
Date submitted
3/03/2023
Date registered
17/03/2023
Date last updated
17/03/2023
Date data sharing statement initially provided
17/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy of supplementation with a proprietary dairy powder in supporting muscle recovery following exercise-induced muscle damage in healthy individuals
Scientific title
Investigating the effect of supplementing with a dairy powder on improving muscle recovery after exercise in healthy individuals
Secondary ID [1] 309122 0
Nil
Universal Trial Number (UTN)
U1111-1288-9812
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle damage 329214 0
Condition category
Condition code
Musculoskeletal 326174 326174 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 design intervention study that will allow us to evaluate whether long-term supplementation with dairy powder supplement 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.

Recruited participants will be evenly randomised into two treatment groups: (1) Dairy powder is a spray-dried buttermilk powder with a complex blend of lipids comprised of saturated (13%) and unsaturated (mono, poly and trans) fatty acids (5.2%), gangliosides (0.4%) and phospholipids (8%) or (2) Placebo powder. At the start of the study arm, the trial co-ordinator will then give participants sachets, with each sachet containing a dose of either the dairy powder supplement (5 g) or the placebo (4.8 g). Participants will be instructed to reconstitute the contents of a single sachet in 250 mL in water with a provided shaker provided to them once daily for four weeks. The trial coordinator will meet with each participant weekly to track their compliance. During the four-week intervention period, participants will be required to avoid consuming omega-3 supplements.

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, 72 and 96 hours post exercise, participants will be required to return to the facility for muscle function and subjective pain assessments.
Intervention code [1] 325572 0
Treatment: Other
Comparator / control treatment
The trim (1% fat) milk power will be used as the placebo in this study. The placebo powder will be produced and packaged by the study's commercial partner in sachets. Each sachet will contain a serve (4.8 g) of the placebo powder and participants will be required to consume a serve of the intervention daily for four weeks. A serve of the placebo powder will contain the equivalent total protein present in a serve of the dairy powder intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 334049 0
Subjective measures of muscle soreness
Timepoint [1] 334049 0
Participants will be asked to complete a short-from McGill pain questionnaire and give a soreness score before and immediately after the bench-stepping exercise on exercise trial days. These same assessments for pain will also be measured 24, 48, 72 and 96 hours post exercise prior to muscle function assessments.
Primary outcome [2] 334050 0
Composite measures of muscle function parameters will include absolute and average peak torque from five maximal isometric, eccentric and concentric quadriceps contractions
Timepoint [2] 334050 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, 72 and 96 hours post exercise trial days.
Secondary outcome [1] 419193 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 [1] 419193 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, 72 and 96 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.
Secondary outcome [2] 419194 0
Composite biomarkers of tissue damage (creatine kinase activity, myoglobin, plasma cartilage oligomeric matrix protein (COMP) and CTX-II concentrations) will be measured from plasma samples.
Timepoint [2] 419194 0
These biomarkers of muscle damage and cartilage degradation 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, 72 and 96 hours post exercise. Creatine kinase activity will be measured by a commercial medical testing laboratory. COMP and CTX-II will be measured using a commercial assay kits.
Secondary outcome [3] 419195 0
Composite cell phenotyping of circulating blood leukocytes
Timepoint [3] 419195 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, 72 and 96 hours post exercise will also undergo the same analysis.

Eligibility
Key inclusion criteria
Healthy males and females 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
Both males and females
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 dairy, (ii) smokers, (iii) 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), (iv) 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 with hypertension (high/low blood pressure) and history of fainting due to low blood pressure, (iii) recent bacterial or viral illness (2-3 weeks) or (iv) are taking medication that impact on blood clotting: warfarin, hearing and non-steroidal anti-inflammatory drugs (NSAIDS).

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, parallel design intervention study consisting of two treatment interventions. Participants will be evenly randomly allocated evenly to into the two treatment groups (Dairy powder supplement and placebo). The randomisation of participants will be undertaken by a fellow scientist not involved in this study using a computer randomisation function. 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, the preparing and packaging the treatment interventions for the participants will be conducted by individuals who will not be involved in any other component of the study. Further, the treatment interventions will be packaged in visually identical sachets to 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 study. Participants will be evenly randomly allocated into two nutrition treatment groups: dairy powder supplement 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
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be expressed as mean +/- standard error. Interaction between dairy powder supplementation and muscle soreness following exercise damage and during recovery will be determined. Likewise, interaction between dairy powder and their effects on muscle function, plasma cytokines, biomarkers of muscle damage and white blood cell counts following muscle damage and during recovery will also be determined. Statistical significance for the comparison between dairy powder and placebo groups will be assessed using paired t-tests. Multiple comparisons will be assessed by two-way ANOVA. 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
Not yet recruiting
Date of first participant enrolment
Anticipated
22/05/2023
Actual
Date of last participant enrolment
Anticipated
29/09/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 25307 0
New Zealand
State/province [1] 25307 0
MANAWATU

Funding & Sponsors
Funding source category [1] 313320 0
Commercial sector/Industry
Name [1] 313320 0
Fonterra Co-operative Group Limited
Country [1] 313320 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] 315069 0
None
Name [1] 315069 0
Address [1] 315069 0
Country [1] 315069 0
Other collaborator category [1] 282578 0
Individual
Name [1] 282578 0
Mr Simon Gilmour
Address [1] 282578 0
Fonterra Research and Development Centre
Dairy Farm Road, Fitzherbert,
Palmerston North 4472
Country [1] 282578 0
New Zealand
Other collaborator category [2] 282579 0
Individual
Name [2] 282579 0
Dr Matt Barnes
Address [2] 282579 0
Massey University
School of Sport, Exercise & Nutrition
Tennent Drive
Palmerston North, 4474
Country [2] 282579 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312548 0
Health and Disability Ethics Committees
Ethics committee address [1] 312548 0
Ethics committee country [1] 312548 0
New Zealand
Date submitted for ethics approval [1] 312548 0
06/03/2023
Approval date [1] 312548 0
Ethics approval number [1] 312548 0

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

Contacts
Principal investigator
Name 125046 0
Dr Dominic Lomiwes
Address 125046 0
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 125046 0
New Zealand
Phone 125046 0
+64 6 355 6113
Fax 125046 0
+64 6 351 7050
Email 125046 0
[email protected]
Contact person for public queries
Name 125047 0
Pramod Gopal
Address 125047 0
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 125047 0
New Zealand
Phone 125047 0
+64 6 953 7678
Fax 125047 0
+64 6 351 7050
Email 125047 0
[email protected]
Contact person for scientific queries
Name 125048 0
Dominic Lomiwes
Address 125048 0
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 125048 0
New Zealand
Phone 125048 0
+64 6 355 6113
Fax 125048 0
+64 6 351 7050
Email 125048 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 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18488Ethical approvalLetter confirming ethical approval from HDEC will be provided upon receipt.  



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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