Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001664831
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
3/12/2021
Date last updated
3/12/2021
Date data sharing statement initially provided
3/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of dietary tryptophan manipulation on serotonin and parameters of motor control on healthy adults
Scientific title
The effects of dietary tryptophan manipulation on serotonin and parameters of motor control on healthy adults
Secondary ID [1] 305014 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurotransmitter level imbalance 323185 0
Protein supplementation 324316 0
Condition category
Condition code
Neurological 320769 320769 0 0
Studies of the normal brain and nervous system
Musculoskeletal 321808 321808 0 0
Normal musculoskeletal and cartilage development and function
Mental Health 321809 321809 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this project, we will study the effects of protein-based supplements ( 40 g of Alpha-lactalbumin and zein, mixed with 500 ml of vegetable juice) on sleepiness, mood, cognition, fatigue and parameters of motor function. Participants will be asked to come to the laboratory in QUT Kelvin Grove for three visits of ~4 hours each (three testing sessions: 1 placebo and 2 intervention supplement sessions) where they will be given a supplement and neuromuscular, psychological and dietary assessments will be performed. Sessions will be separated by at least 1 week wash-out period. This will be a randomised double-blind cross over study. The results of this research will contribute to the understanding of the effects of serotonin on sleepiness, mood, cognition, motor function and fatigue. Most importantly, this study will test the feasibility of using food as a strategy for modifying neurotransmitter levels and its influence on psychological parameters, muscle fatigue and strength development.
The supplement protocol is based on a previous research study by Fernstrom 2013 (https://doi.org/10.1016/j.clnu.2012.11.027).
All sessions will be delivered by a PhD student with background in Nutrition and exercise testing and supervisor briefing in neuromuscular assessments.
Intervention code [1] 321413 0
Behaviour
Intervention code [2] 322201 0
Treatment: Other
Comparator / control treatment
The control condition will perform the same interventions with the exception of a placebo (control) supplement (consume 40g of corn flour/corn starch).
Control group
Placebo

Outcomes
Primary outcome [1] 328581 0
Changes in maximal voluntary isometric contraction (MVC): Assessed using a leg dynamometer and handgrip transducer.
Timepoint [1] 328581 0
Baseline and 90 min after consuming the supplement (on each visit)
Primary outcome [2] 328582 0
Time to fatigue (TTF): Assessed using a leg dynamometer.
Timepoint [2] 328582 0
Baseline and 2 h after supplement consumption (on each visit)
Primary outcome [3] 328583 0
Changes in estimates of persistent inward currents (PICs): Assessed using high density electromyography (EMG) placed on their triceps surae (gastrocnemius and soleus muscle), while sitting on the leg dynanometer.
Timepoint [3] 328583 0
Baseline and 90 min after consumption of the supplement (on each visit).
Secondary outcome [1] 403024 0
Primary outcome: Rate of force development (RFD). Assessed using a leg dynamometer.
Timepoint [1] 403024 0
Baseline and 90 min after consuming the supplement (on each visit)
Secondary outcome [2] 403026 0
Primary outcome: - Changes in the brief assessment of mood (BAM),
Timepoint [2] 403026 0
Baseline, 90 min and 120 min after consuming the supplement (on each visit).
Secondary outcome [3] 403027 0
Primary outcome: Cognition: The Trail Maker Test (TMT),
Timepoint [3] 403027 0
Baseline, 90 min and 120 min after consuming the supplement (on each visit).
Secondary outcome [4] 403028 0
Primary outcome: Perception of fatigue (BORG scale),
Timepoint [4] 403028 0
Baseline and 2 h after consuming the supplement (on each visit)
Secondary outcome [5] 403029 0
Primary outcome: Sleepiness (Stanford sleepiness scale).
Timepoint [5] 403029 0
Baseline, 90 min and 120 min after consuming the supplement (on each visit).

Eligibility
Key inclusion criteria
non-smokers, BMI <30 kg/m2.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Musculoskeletal disorders that limit performance in the assessed limb; diagnosed neurological disorders (e.g. amyotrophic lateral sclerosis or ALS); diagnosed serotonergic disorders (e.g. depression); consumption of drugs that affect serotonin and noradrenaline release (e.g. recreational drugs, SRRIs or antidepressants); diagnosed Vitamin D or B6 deficiency; diagnosed with high cholesterol; diagnosed with iron anaemia deficiency. Women must not be pregnant, breast feeding or menopausal.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/08/2020
Date of last participant enrolment
Anticipated
Actual
22/12/2020
Date of last data collection
Anticipated
Actual
22/12/2020
Sample size
Target
15
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 309403 0
University
Name [1] 309403 0
Queensland University of Technology
Country [1] 309403 0
Australia
Primary sponsor type
Individual
Name
Karen Mackay
Address
Queensland University of Technology
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 310372 0
Individual
Name [1] 310372 0
Gabriel Trajano
Address [1] 310372 0
Queensland University of Technology
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country [1] 310372 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309209 0
QUT Human Research Ethics Committee
Ethics committee address [1] 309209 0
OREI - Office of Research Ethics and Integrity
GPO Box 2434 QLD 4000
Ethics committee country [1] 309209 0
Australia
Date submitted for ethics approval [1] 309209 0
29/10/2019
Approval date [1] 309209 0
18/05/2020
Ethics approval number [1] 309209 0
1900001100

Summary
Brief summary
The purpose of this research is to examine the effects of protein supplements on serotonin levels, mood, cognition, fatigue, sleepiness and parameters of muscle strength. Your participation will involve: 3 morning testing sessions of ~ 3 hours each to the Exercise Physiology Research Laboratory at QUT, Kelvin Grove campus. Each visit will consist of questionnaires of sleepiness, mood, cognition, neuromuscular testing on your calf muscles, the consumption of a supplement and repeating all testing plus performing a muscle fatigue protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113350 0
Miss Karen Mackay
Address 113350 0
Queensland University of Technology
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country 113350 0
Australia
Phone 113350 0
+61478761076
Fax 113350 0
Email 113350 0
[email protected]
Contact person for public queries
Name 113351 0
Karen Mackay
Address 113351 0
Queensland University of Technology
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country 113351 0
Australia
Phone 113351 0
+61478761076
Fax 113351 0
Email 113351 0
[email protected]
Contact person for scientific queries
Name 113352 0
Karen Mackay
Address 113352 0
Queensland University of Technology
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country 113352 0
Australia
Phone 113352 0
+61 478761076
Fax 113352 0
Email 113352 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12825Study protocol  [email protected]
14104Informed consent form  [email protected]
14105Ethical approval  [email protected]



Results publications and other study-related documents

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