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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Salt intake

Cortisol production

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Metabolic and Endocrine

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]

Treatment: Other

Comparator / control treatment

Low salt meal (0.02 g; 9 mg sodium).

Control group

Dose comparison

Outcomes

Primary outcome [1]

Change in urinary cortisol concentrations measured by Enzyme-linked immunosorbent assay.

Timepoint [1]

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]

Change in salivary cortisol concentrations measured by Enzyme-linked immunosorbent assay.

Timepoint [2]

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]

Change in plasma adrenocorticotropic hormone concentrations measured by Enzyme-linked immunosorbent assay.

Timepoint [3]

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]

Change in urinary sodium concentrations measured by indirect ion-selective electrode potentiometry.

Timepoint [1]

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]

Change in heart rate measured using an automated clinical sphygmomanometer.

Timepoint [2]

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]

Change in systolic blood pressure measured using an automated clinical sphygmomanometer.

Timepoint [3]

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]

Change in diastolic blood pressure measured using an automated clinical sphygmomanometer.

Timepoint [4]

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]

Change in blood glucose concentrations measured using a blood glucose meter.

Timepoint [5]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

221 Burwood Highway,
Burwood VIC 3125

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University

Address

221 Burwood Highway,
Burwood VIC 3125,

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee of Deakin University

Ethics committee address [1]

Deakin University,
221 Burwood Highway, 
Burwood VIC 3125,

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/01/2019

Ethics approval number [1]

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

Dr Anne Turner

Address

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

Australia

Phone

+61 3 9244 6950

Fax

[email protected]

Contact person for public queries

Name

Anne Turner

Address

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

Australia

Phone

+61 3 9244 6950

Fax

[email protected]

Contact person for scientific queries

Name

Anne Turner

Address

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

Australia

Phone

+61 3 9244 6950

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
19059	Ethical 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.

Trial Review

Documents added manually

Documents added automatically