Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000587505
Ethics application status
Approved
Date submitted
22/03/2024
Date registered
8/05/2024
Date last updated
8/05/2024
Date data sharing statement initially provided
8/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study: Response to Stress and Relaxation in Healthy Adults
Scientific title
Pilot Study Investigating Relationship between Habitual Diet and Response to Acute Stress or Relaxation in Healthy Adults
Secondary ID [1] 311802 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 333321 0
Anxiety 333322 0
Condition category
Condition code
Mental Health 330007 330007 0 0
Anxiety
Metabolic and Endocrine 330008 330008 0 0
Normal metabolism and endocrine development and function
Mental Health 330009 330009 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will answer questionaires on habitual diet (food frequency questionaire) and potentially confounding variables sleep, exercise, personality, and trait anxiety. They will then be exposed to a stress intervention (trier social stress test) and a relaxation intervention (progressive muscle relaxaion). Self-reported stress and anxiety, salivary cortisol, and heart rate variability will be measured throughout the two interventions.
The trier social stress test is 20 minutes long, and will be administred in groups of four. It involves participants playing the role of a job applicant and giving a 2 minute speech followed by a maths task, in front of a video camera and researchers who are posing as interviewers. The progressive muscle relaxation will be 20 minutes long and involves participants sitting with their eyes closed and listening to a recording which instructs participants to create tension in a certain muscle group (e.g. forehead) and then relax, progressing through several muscle groups in the body. The stress and relaxation intervention will be done on the same day, seperated by 1 hour. Both interventions will be done in person with supervison by research staff.
Intervention code [1] 328249 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337759 0
Cortisol
Timepoint [1] 337759 0
Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions
Primary outcome [2] 337760 0
Self-reported stress
Timepoint [2] 337760 0
Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions
Primary outcome [3] 337761 0
Self-reported anxiety
Timepoint [3] 337761 0
Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions
Secondary outcome [1] 433193 0
Cytokines (interferon-gamma (IFN-gamma), cytokine-induced neutrophil chemoattractant type-1 (CINC-1), monocyte chemoattractant protein-1 (MCP-1), tumour necrosis factor-alpha (TNF-a), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-18, IL-12p70, IL-1ß, IL-17A, IL-33, IL-1a, and IL-6) will be measured in combined samples. This is an exploratory outcome.
Timepoint [1] 433193 0
Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions
Secondary outcome [2] 434601 0
Heart Rate Variability
Timepoint [2] 434601 0
Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions

Eligibility
Key inclusion criteria
Healthy males and females
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include any serious ongoing medical conditions, low or high blood pressure (systolic less than 90 or higher than 120 or diastolic less than 60 or higher than 80), body mass index outside 19-26 kg/m2, and medication which can affect stress response including but not limited to antidepressant medication, blood pressure medication and asthma medication. Sex hormones can affect response to acute stress so women who are pregnant, lactating or using hormonal contraceptives will be excluded, and sessions will be run only during women’s luteal phase. People who work night shifts or have previously completed the Trier Social Stress Test procedure will also be excluded, as well as those with a current or prior diagnosis of Major Axis I DSM-IV disorders (American Psychiatric Association, 1994) including drug abuse or dependence, or high levels of anxiety or depression (The Hospital Anxiety and Depression Scale score above 15).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 26213 0
New Zealand
State/province [1] 26213 0
Manawatu

Funding & Sponsors
Funding source category [1] 316138 0
Other Collaborative groups
Name [1] 316138 0
The New Zealand Institute for Plant & Food Research
Country [1] 316138 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
The New Zealand Institute for Plant & Food Research
Address
Country
New Zealand
Secondary sponsor category [1] 318313 0
None
Name [1] 318313 0
Address [1] 318313 0
Country [1] 318313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314963 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314963 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 314963 0
New Zealand
Date submitted for ethics approval [1] 314963 0
08/12/2023
Approval date [1] 314963 0
12/02/2024
Ethics approval number [1] 314963 0
2024 EXP 18588

Summary
Brief summary
The overall aim of this research is to test whether habitual dietary components or patterns are associated with differences in an individual’s response to acute psychosocial stress, or a de-stress (relaxation) intervention. The hypothesis is that a healthy diet will be associated with better recovery from acute stress, and a better response to a relaxation intervention. The ultimate outcome is to identify dietary interventions and mechanisms which have the potential to reduce stress, increase response to mental health treatment, and increase stress-resilience, and can be investigated further. The objective of this proposed pilot study is to ensure efficacy of the acute stress and relaxation methods (and biological response) before running a larger study, and to determine participant numbers needed for a sufficiently powered larger study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133270 0
Dr Tracey Bear
Address 133270 0
Plant & Food Research Food Industry Science Centre, Fitzherbert Science Centre, 23 Batchelar Road, Palmerston North 4410, New Zealand
Country 133270 0
New Zealand
Phone 133270 0
+64 211702101
Fax 133270 0
Email 133270 0
tracey.bear@plantandfood.co.nz
Contact person for public queries
Name 133271 0
Tracey Bear
Address 133271 0
Plant & Food Research Food Industry Science Centre, Fitzherbert Science Centre, 23 Batchelar Road, Palmerston North 4410, New Zealand
Country 133271 0
New Zealand
Phone 133271 0
+64 211702101
Fax 133271 0
Email 133271 0
tracey.bear@plantandfood.co.nz
Contact person for scientific queries
Name 133272 0
Tracey Bear
Address 133272 0
Plant & Food Research Food Industry Science Centre, Fitzherbert Science Centre, 23 Batchelar Road, Palmerston North 4410, New Zealand
Country 133272 0
New Zealand
Phone 133272 0
+64 211702101
Fax 133272 0
Email 133272 0
tracey.bear@plantandfood.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be shared for confidentiality and intellectual property purposes.


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
No additional documents have been identified.