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Trial registered on ANZCTR


Registration number
ACTRN12615001050549
Ethics application status
Approved
Date submitted
27/08/2015
Date registered
7/10/2015
Date last updated
20/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
In healthy adults, is provision of nutritional support effective for following low dietary sodium intake?
Scientific title
A pilot study examining the effect of nutritional support and dietary support aids for healthy adults following a low sodium diet (aiming for <2000mg/day) on compliance barriers and dietary changes.
Secondary ID [1] 287311 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dietary intake
295945 0
Blood pressure 296191 0
Cardiovascular disease 296192 0
Condition category
Condition code
Diet and Nutrition 296217 296217 0 0
Other diet and nutrition disorders
Public Health 296220 296220 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive verbal and written nutrition education from a student dietitian, focusing on how to select and prepare low sodium foods. This includes an information booklet compiled by the student dietitian which includes recipes, tips on food label reading and dietary practice. Participants will attend weekly one-on-one consultation clinics (30 min) for four weeks. Dietary sodium intake is measured at baseline using 2 day weighed diet record, 24 hour diet recall and 24 hour urine. Participants will then attempt to undertake a low sodium diet for four weeks(target <2000 mg/day) from the second weekly consultation visit(once baseline measures have been taken), consuming food and beverages of their own choice. Participants will then receive tailored advice and support for maintaining a low sodium diet from a student dietitian.

Over the period there will be a log of attendance. At four weeks participants will provide a 2 day weighed diet record, a 24h diet recall and a 24-hour urine collection to assess nutrient intakes and monitor adherence to the intervention. In addition, participants will attend a semi-structured interview at the end of the low sodium diet to evaluate effectiveness of the dietary support aids.
Intervention code [1] 292631 0
Prevention
Intervention code [2] 292632 0
Treatment: Other
Intervention code [3] 292633 0
Lifestyle
Comparator / control treatment
No control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295885 0
Barriers and supports towards following a low sodium diet as assessed by semi-structured interview with the participants
Timepoint [1] 295885 0
At the end of the four-week low sodium diet period
Primary outcome [2] 295886 0
Dietary sodium intake associated with following a low sodium diet as assessed by 24-hour urine collections, 24-hour diet recalls and 2-day weighed diet records.
Timepoint [2] 295886 0
At baseline and at the end of the low sodium diet period (week 4).
Secondary outcome [1] 316828 0
Free sugars will be assessed through 2 day diet weighed diet records
Timepoint [1] 316828 0
At baseline and at the end of week 4.
Secondary outcome [2] 317656 0
Potassium intake will be assessed through 24 hour urine collection
Timepoint [2] 317656 0
At baseline and at the end of week 4.

Eligibility
Key inclusion criteria
Healthy males and females aged 18-65 years, and residing in Dunedin for the duration of the study.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those that are currently on a diet or already restricting their sodium intake, or who are taking diuretics

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Descriptive analysis of dietary data.
Thematic analysis of interview (qualitative) data

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7107 0
New Zealand
State/province [1] 7107 0
Otago

Funding & Sponsors
Funding source category [1] 291877 0
University
Name [1] 291877 0
University of Otago
Address [1] 291877 0
Department of Human Nutrition
PO Box 56
University of Otago
Dunedin 9054
New Zealand
Country [1] 291877 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
PO Box 56
University of Otago
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 290543 0
None
Name [1] 290543 0
Address [1] 290543 0
Country [1] 290543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293384 0
University of Otago Human Ethics Committee
Ethics committee address [1] 293384 0
University of Otago
P.O. Box 56
Dunedin 9054
New Zealand
Ethics committee country [1] 293384 0
New Zealand
Date submitted for ethics approval [1] 293384 0
Approval date [1] 293384 0
21/07/2015
Ethics approval number [1] 293384 0
15/096

Summary
Brief summary
This project is a pilot for a larger study examining the effects of diets that are consistent with WHO recommendations on sodium, and draft recommendations on sugar on blood pressure and other cardiovascular disease risk markers.

To reduce the global burden of high blood pressure on cardiovascular disease and morbidity, the WHO recommends adults consume <2000 mg sodium/day. Currently, New Zealand adults have a mean intake of around 3300mg/day. Previous studies have indicated it may be difficult for people to adhere to the WHO sodium target intake, and barriers and supports to adherence are not known. It is also unknown whether adhering to a low sodium diet is associated with other dietary changes that can affect health (It is likely that such changes will be beneficial to health but this has not been tested). Therefore, more research is needed to investigate the effectiveness of dietary support aids, and to explore whether low sodium diets are associated with other dietary changes that may influence cardiovascular disease risk markers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59650 0
Dr Rachael McLean
Address 59650 0
Departments of Preventative & Social Medicine/Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 59650 0
New Zealand
Phone 59650 0
+64 3 479 7943
Fax 59650 0
Email 59650 0
rachael.mclean@otago.ac.nz
Contact person for public queries
Name 59651 0
Dr Rachael McLean
Address 59651 0
Departments Preventative & Social Medicine/Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 59651 0
New Zealand
Phone 59651 0
+64 3 479 7943
Fax 59651 0
Email 59651 0
rachael.mclean@otago.ac.nz
Contact person for scientific queries
Name 59652 0
Dr Rachael McLean
Address 59652 0
Departments Preventative & Social Medicine/Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 59652 0
New Zealand
Phone 59652 0
+64 3 479 7943
Fax 59652 0
Email 59652 0
rachael.mclean@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary