Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000490673
Ethics application status
Approved
Date submitted
2/05/2023
Date registered
12/05/2023
Date last updated
12/05/2023
Date data sharing statement initially provided
12/05/2023
Date results information initially provided
12/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a high-salt meal on cortisol production in young adults
Scientific title
The effect of a high-salt meal on cortisol production in young adults
Secondary ID [1] 309558 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Salt intake 329866 0
Cortisol production 329952 0
Condition category
Condition code
Diet and Nutrition 326772 326772 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 326773 326773 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants consumed one high salt meal (3.82 g; 1529 mg sodium) and one low salt meal (0.02 g; 9 mg sodium) in a randomized cross-over design. The high and low salt meals consisted of tomato soup formulations administered by researchers. There were 6 – 21 days of wash-out between the meals. The trial took place at the Clinical Research Facility at the School of Exercise and Nutrition Sciences, Deakin University and participants visited the facility individually for the trial. Participants attended the research facility from 1200h - 1700h on each day of meal administration. The same treatments were administered to all participants. Adherence was confirmed by observation by researchers who were present during the trial.
Intervention code [1] 325989 0
Treatment: Other
Comparator / control treatment
Low salt meal (0.02 g; 9 mg sodium).
Control group
Dose comparison

Outcomes
Primary outcome [1] 334625 0
Change in urinary cortisol concentrations measured by Enzyme-linked immunosorbent assay.
Timepoint [1] 334625 0
Urine samples were collected immediately before (Time = 0 minutes) and 20, 40, 60, 80, 100, 120, 140, 160, 180 minutes after each test meal.
Primary outcome [2] 334626 0
Change in salivary cortisol concentrations measured by Enzyme-linked immunosorbent assay.
Timepoint [2] 334626 0
Saliva samples were collected immediately before (Time = 0 minutes) and 10, 20, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180 minutes after each test meal.
Primary outcome [3] 334627 0
Change in plasma adrenocorticotropic hormone concentrations measured by Enzyme-linked immunosorbent assay.
Timepoint [3] 334627 0
Plasma samples were collected immediately before (Time = 0 minutes) and 10, 20, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180 minutes after each test meal.
Secondary outcome [1] 421452 0
Change in urinary sodium concentrations measured by indirect ion-selective electrode potentiometry.
Timepoint [1] 421452 0
Urine samples were collected immediately before (Time = 0 minutes) and 20, 40, 60, 80, 100, 120, 140, 160, 180 minutes after each test meal.
Secondary outcome [2] 421453 0
Change in heart rate measured using an automated clinical sphygmomanometer.
Timepoint [2] 421453 0
Heart rate was measured immediately before (Time = 0 minutes) and 10, 20, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180 minutes after each test meal.
Secondary outcome [3] 421454 0
Change in systolic blood pressure measured using an automated clinical sphygmomanometer.
Timepoint [3] 421454 0
Systolic blood pressure was measured immediately before (Time = 0 minutes) and 10, 20, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180 minutes after each test meal.
Secondary outcome [4] 421455 0
Change in diastolic blood pressure measured using an automated clinical sphygmomanometer.
Timepoint [4] 421455 0
Diastolic blood pressure was measured immediately before (Time = 0 minutes) and 10, 20, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180 minutes after each test meal.
Secondary outcome [5] 421456 0
Change in blood glucose concentrations measured using a blood glucose meter.
Timepoint [5] 421456 0
Blood samples were collected immediately before (Time = 0 minutes) and 10, 20, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180 minutes after each test meal.

Eligibility
Key inclusion criteria
Eligible participants were male or female (18-50 years of age) and not taking medication for blood pressure or diabetes.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recruits were excluded if they reported any diagnosis with Cushing’s syndrome, any stress or anxiety disorder, depression, any diseases of the adrenal gland, Type 2 diabetes, heart disease, high cholesterol, stroke or cancer or use of medication known to affect cortisol levels. Pregnant or breast-feeding females were excluded, as were participants who recorded resting blood pressure greater than 160/90 mmHg or body mass index (BMI) greater than or equal to 30 kg/m2.

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)
The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which order of treatments (i.e. high salt first or high salt second) the subject would be allocated. The allocation of treatment order occurred at a later date.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2019
Date of last participant enrolment
Anticipated
Actual
14/08/2019
Date of last data collection
Anticipated
Actual
26/09/2019
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313762 0
University
Name [1] 313762 0
Deakin University
Country [1] 313762 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway,
Burwood VIC 3125,

Country
Australia
Secondary sponsor category [1] 315591 0
None
Name [1] 315591 0
Address [1] 315591 0
Country [1] 315591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312920 0
Human Research Ethics Committee of Deakin University
Ethics committee address [1] 312920 0
Deakin University,
221 Burwood Highway,
Burwood VIC 3125,

Ethics committee country [1] 312920 0
Australia
Date submitted for ethics approval [1] 312920 0
Approval date [1] 312920 0
11/01/2019
Ethics approval number [1] 312920 0
2018-384

Summary
Brief summary
The current study aimed to demonstrate an acute cortisol response following a single high salt meal. While studies to date show an association between high dietary salt-intake over several days and 24-h urinary cortisol, no studies have investigated the acute relationship between salt-intake and cortisol production. The primary aim of our study was to demonstrate salt-induced cortisol production in an acute setting. Our secondary aim was to demonstrate this cortisol production in the absence of an adrenocorticotropic hormone (ACTH) response. We hypothesized that urinary cortisol but not plasma ACTH will increase following a single high-salt meal. To further characterize the role of high salt intake, we measured salivary cortisol, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and blood glucose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126338 0
Dr Anne Turner
Address 126338 0
Institute for Physical Activity and Nutrition (IPAN),
School of Exercise and Nutrition Sciences
Deakin University,
Melbourne Burwood Campus,
221 Burwood Highway,
Burwood VIC 3125,
Australia
Country 126338 0
Australia
Phone 126338 0
+61 3 9244 6950
Fax 126338 0
Email 126338 0
anne.turner@deakin.edu.au
Contact person for public queries
Name 126339 0
Dr Anne Turner
Address 126339 0
Institute for Physical Activity and Nutrition (IPAN),
School of Exercise and Nutrition Sciences
Deakin University,
Melbourne Burwood Campus,
221 Burwood Highway,
Burwood VIC 3125,
Australia
Country 126339 0
Australia
Phone 126339 0
+61 3 9244 6950
Fax 126339 0
Email 126339 0
anne.turner@deakin.edu.au
Contact person for scientific queries
Name 126340 0
Dr Anne Turner
Address 126340 0
Institute for Physical Activity and Nutrition (IPAN),
School of Exercise and Nutrition Sciences
Deakin University,
Melbourne Burwood Campus,
221 Burwood Highway,
Burwood VIC 3125,
Australia
Country 126340 0
Australia
Phone 126340 0
+61 3 9244 6950
Fax 126340 0
Email 126340 0
anne.turner@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data presented in this study are not publicly available due to ethical and privacy reasons. The results will be published in a journal article. Due to confidentiality we will not be providing individual data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19059Ethical approval    385820-(Uploaded-02-05-2023-14-32-46)-Study-related document.pdf



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.