Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000476437p
Ethics application status
Submitted, not yet approved
Date submitted
16/04/2025
Date registered
19/05/2025
Date last updated
19/05/2025
Date data sharing statement initially provided
19/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Can social support change the impact of stress on gastric functioning?
Scientific title
The Effects of Social Support on Stress and Gastric Motility during the Maastricht Acute Stress Test in Healthy Adults
Secondary ID [1] 314214 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disorders of Gut-Brain Interaction 337111 0
Condition category
Condition code
Oral and Gastrointestinal 333533 333533 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a two-arm randomised controlled trial with a single intervention group. Participants will attend a single 120-minute laboratory session during which they will undergo a stressful task, as explained below. Participants will not be told that there are two different groups. They will be told that we are looking at their general levels of social support at baseline and how that correlates with outcomes.

All participants in both groups will arrive at the laboratory and physiological measures of stress and gastric activity will be set-up. These include a non-invasive Body Surface Gastric Mapping device designed by Alimetry Ltd, and non-invasive sensors that detect changes in heart rate, heart rate variability, blood pressure, electrodermal activity, and hand temperature. The Gastric Alimetry device will be used to measure gastric activity continuously throughout the study, for a period of approximately 110 minutes. The device will be applied to participants using a standardised procedure in which the skin is prepped with NuPrep gel before the adhesive electrode array is placed. Participants will fill in questionnaires about their experiences of social support in adulthood and childhood and then consume a standardised meal. The standardised meal includes a nutritional shake and protein bar, collectively consisting of approximately 482 kCal. Participants will then complete the 10-minute Maastricht Acute Stress Test to induce a stress response, and then remaining seated in a recliner during a post-stressor observation period.

Participants who were randomly assigned to the intervention group will receive a supportive behaviour intervention administered by the experimenter. Throughout the procedure, the experimenter will engage in evidence-based supportive behaviours. These behaviours will be standardised across participants in accordance with a script. The intervention consists of verbal behavioural manipulations of experimenter warmth, competence, and provision of information to the participant. These manipulations are designed to produce high levels of emotional and informational support. The extent of participant engagement with the intervention will be directly observed. The experimenter is a postgraduate student in health psychology who has received training in the provision of supportive behaviours. Study-specific training will be administered by the project supervisor and an additional advisor 3-weeks prior to the first participant enrolment, and will occur face-to-face over 3 hours.
Intervention code [1] 330822 0
Behaviour
Comparator / control treatment
Participants who are allocated to the control group will receive standard administration of the stressor without supportive behaviours from the experimenter. The experimenter will enact scripted behaviours that convey standard levels of warmth and competence towards participants, and provide standard required information about the procedures. The control group will be exposed to identical stress induction procedures to that of the intervention group, without the supportive behaviour intervention.
Control group
Active

Outcomes
Primary outcome [1] 341114 0
Gastric myoelectrical activity
Timepoint [1] 341114 0
This will be continually measured throughout a single experiment session. Data will be analysed for timepoints at baseline, postprandial, during the stressor, and post-stressor.
Secondary outcome [1] 446332 0
Heart rate
Timepoint [1] 446332 0
This will be continually measured throughout a single experiment session. Data will be analysed for timepoints at baseline, postprandial, during the stressor, and post-stressor.
Secondary outcome [2] 446333 0
Participant perceptions of experimenter behaviour
Timepoint [2] 446333 0
Measurements will be taken at the end of the experiment after completion of all procedures.
Secondary outcome [3] 446368 0
Self-reported stress
Timepoint [3] 446368 0
Measured at baseline, postprandial, immediately post-stressor, and 10-minutes post-pressor.
Secondary outcome [4] 446370 0
Subjective levels of pain
Timepoint [4] 446370 0
Measured immediately post-stressor
Secondary outcome [5] 446941 0
Blood Pressure
Timepoint [5] 446941 0
Measurements will be taken at baseline, postprandial, immediately post-stressor, and 10 minutes post-stressor
Secondary outcome [6] 446942 0
Heart rate variability
Timepoint [6] 446942 0
This will be continually measured throughout a single experiment session. Data will be analysed for timepoints at baseline, postprandial, during the stressor, and post-stressor.
Secondary outcome [7] 446943 0
Electrodermal activity
Timepoint [7] 446943 0
This will be continually measured throughout a single experiment session. Data will be analysed for timepoints at baseline, postprandial, during the stressor, and post-stressor.
Secondary outcome [8] 446944 0
Hand temperature
Timepoint [8] 446944 0
This will be continually measured throughout a single experiment session. Data will be analysed for timepoints at baseline, postprandial, during the stressor, and post-stressor.

Eligibility
Key inclusion criteria
The study sample will include healthy adults aged 18-65 who are fluent in English and are capable of providing informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) history of gastrointestinal conditions or surgeries
(2) pregnant or lactating
(3) unable to sit comfortably in a reclined, supine position
(4) known allergies or sensitivities to adhesives and cosmetic lotions
(5) current abdominal skin damage
(6) regular cannabis use
(7) history of any cardiovascular condition
(8) history of Raynaud’s syndrome
(9) current injury on the limb to be immersed in water
(10) presence of any metabolic, endocrine, neurogenic, or serious illness.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
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
2/06/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
17/10/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 26979 0
New Zealand
State/province [1] 26979 0

Funding & Sponsors
Funding source category [1] 318730 0
University
Name [1] 318730 0
University of Auckland
Country [1] 318730 0
New Zealand
Funding source category [2] 318731 0
Commercial sector/Industry
Name [2] 318731 0
Alimetry Ltd
Country [2] 318731 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321166 0
Commercial sector/Industry
Name [1] 321166 0
Alimetry Ltd
Address [1] 321166 0
Country [1] 321166 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317344 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 317344 0
Ethics committee country [1] 317344 0
New Zealand
Date submitted for ethics approval [1] 317344 0
01/05/2025
Approval date [1] 317344 0
Ethics approval number [1] 317344 0

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

Contacts
Principal investigator
Name 140746 0
Prof Elizabeth Broadbent
Address 140746 0
The University of Auckland, 22-30 Park Avenue, Grafton, Auckland 1023
Country 140746 0
New Zealand
Phone 140746 0
+64 93737599
Fax 140746 0
Email 140746 0
[email protected]
Contact person for public queries
Name 140747 0
Elizabeth Broadbent
Address 140747 0
The University of Auckland, 22-30 Park Avenue, Grafton, Auckland 1023
Country 140747 0
New Zealand
Phone 140747 0
+64 93737599
Fax 140747 0
Email 140747 0
[email protected]
Contact person for scientific queries
Name 140748 0
Elizabeth Broadbent
Address 140748 0
The University of Auckland, 22-30 Park Avenue, Grafton, Auckland 1023
Country 140748 0
New Zealand
Phone 140748 0
+64 93737599
Fax 140748 0
Email 140748 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.