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Trial registered on ANZCTR


Registration number
ACTRN12617001039370
Ethics application status
Approved
Date submitted
14/07/2017
Date registered
17/07/2017
Date last updated
12/03/2019
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can seaweed supplementation reduce cardiovascular disease risk?
Scientific title
The impact of 12-weeks supplementation with a polyphenol-rich seaweed extract on cholesterol levels in adults with elevated fasting LDL-cholesterol
Secondary ID [1] 292039 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 303435 0
hypercholesterolaemia 303436 0
type 2 diabetes 303437 0
Condition category
Condition code
Diet and Nutrition 302846 302846 0 0
Other diet and nutrition disorders
Cardiovascular 302847 302847 0 0
Other cardiovascular diseases
Metabolic and Endocrine 303376 303376 0 0
Diabetes
Alternative and Complementary Medicine 303377 303377 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of 12 weeks supplementation with a commercially available polyphenol-rich seaweed extract, called Maritech Synergy.
The extract will be consumed in the form of oral tablets, in a dose of 2000 mg extract (containing 600 mg polyphenols) taken daily, over the course of 12 weeks.
Adherence will be assessed by collecting used tablet boxes from participants and counting the leftover tablets, as well as through the use of a check off chart.
Intervention code [1] 298167 0
Treatment: Other
Comparator / control treatment
The comparator consists of 12 weeks supplementation with a placebo.
The placebo will be taken in identical oral tablets, but will contain rice flour in a dose of 2000 mg. Also to be consumed daily over the course of 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 302241 0
Change in fasting LDL cholesterol level as assessed by automated analyser (Indiko).
Timepoint [1] 302241 0
Comparing baseline and 12 weeks post commencement of the intervention
Secondary outcome [1] 335259 0
Changes in fasting lipid profile (total cholesterol, HDL cholesterol, triglycerides) as assessed by automated analyser (Indiko).
Timepoint [1] 335259 0
Comparing baseline and 12 weeks post commencement of the intervention
Secondary outcome [2] 335260 0
Changes in fasting glucose, as assessed by automated analyser (Indiko), and insulin, as assessed by ELISA.
Timepoint [2] 335260 0
Comparing baseline and 12 weeks post commencement of the intervention
Secondary outcome [3] 335261 0
Changes in inflammatory markers (including CRP and TNF-alpha) as assessed by plasma assay
Timepoint [3] 335261 0
Comparing baseline and 12 weeks post commencement of the intervention
Secondary outcome [4] 335870 0
Changes in mood and markers of cognitive function as measured by a cognitive array comprising a series of tasks from the Computerised Mental Performance Assessment System (COMPASS) (optional add-on for participants)
Timepoint [4] 335870 0
Comparing baseline and 12 weeks post commencement of the intervention
Secondary outcome [5] 336832 0
Assessment of participant compliance to the intervention as measured by check-off sheets and collection and counting of left-over capsules.
Timepoint [5] 336832 0
6 weeks and 12 weeks post commencement of the intervention
Secondary outcome [6] 336934 0
Investigation of early changes in fasting cholesterol levels as measured by automated analyser (Indiko)
Timepoint [6] 336934 0
6 weeks post commencement of the intervention
Secondary outcome [7] 336935 0
Investigation of early changes in fasting glucose levels as measured by automated analyser (Indiko)
Timepoint [7] 336935 0
6 weeks post commencement of the intervention
Secondary outcome [8] 336936 0
Investigation of early changes in mood and markers of cognitive function as measured by a cognitive array comprising a series of tasks from the Computerised Mental Performance Assessment System (COMPASS) (optional add-on for participants)
Timepoint [8] 336936 0
6 weeks post commencement of the intervention

Eligibility
Key inclusion criteria
Body mass index from 27 to 35 kg/m2 (25 to 35 kg/m2 for people of Asian background)
Fasting LDL cholesterol level above 2.0 mmol/L
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gastrointestinal issues that may affect the absorption and intestinal actions of the polyphenols,
Taking medication for cholesterol or blood pressure control or any other medications that may influence results.
Taking other natural health products known to impact on polyphenols e.g. fish oil,
Women who are breastfeeding or pregnant,
Individuals with liver/thyroid issues,
Having undergone major surgery in the past 6 months,
Consuming more than 4 standard drinks per day, or 14 standard drinks per week,
Cigarette smoking.
Having an implanted cardiac defibrillator.
Individuals with depression, anxiety or dementia (cognitive aspect only)

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)
Allocation will be concealed by using letter codes on all tablet containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed using computerized sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analyses were performed to identify the required sample size to detect a difference between the intervention and placebo groups for change in fasting LDL cholesterol, at a power of 80%. Based on data from the literature a total of 52 individuals is required, with 26 per treatment group. Fifty-eight individuals will be recruited to allow for a dropout rate of approximately 10%.

All results will be assessed for normality. Where possible, skewed distributions will be log transformed before analysis. The level of significance is accepted at p= <0.05. Data will be expressed as mean ± SD (parametric) or median ± interquartile range (non-parametric) unless otherwise stated. Analyses will be performed using Statistical Package for Social Sciences (SPSS) version 21.0 (SPSS Inc., Chicago, IL). Independent samples t-tests, or Mann-Whitney U tests for non-parametric variables, will be used to determine differences between the groups in the changes in outcomes from baseline to week 12 (primary outcome). A mixed between-within subjects analysis of variance will be used to assess the secondary outcome of differences between the groups across the three time points (baseline, week 6 and week 12).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/08/2017
Actual
23/08/2017
Date of last participant enrolment
Anticipated
Actual
4/09/2018
Date of last data collection
Anticipated
Actual
4/12/2018
Sample size
Target
58
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296571 0
Commercial sector/Industry
Name [1] 296571 0
Marinova Pty Ltd
Country [1] 296571 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 295529 0
None
Name [1] 295529 0
Address [1] 295529 0
Country [1] 295529 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297788 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 297788 0
Monash University Clayton Campus, Wellington Road, Clayton VIC 3800
Ethics committee country [1] 297788 0
Australia
Date submitted for ethics approval [1] 297788 0
05/05/2017
Approval date [1] 297788 0
08/05/2017
Ethics approval number [1] 297788 0
2017-8689-10379

Summary
Brief summary
The primary purpose of this research is to determine whether consuming a polyphenol-rich seaweed supplement for 12 weeks will reduce LDL cholesterol levels in adults with elevated LDL cholesterol at baseline. It is hypothesised that the group who receive the seaweed extract supplement will have a greater reduction in LDL cholesterol levels than the group who receive the rice flour supplement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75114 0
A/Prof Maxine Bonham
Address 75114 0
Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 75114 0
Australia
Phone 75114 0
+61 3 9902 4272
Fax 75114 0
Email 75114 0
[email protected]
Contact person for public queries
Name 75115 0
Margaret Murray
Address 75115 0
Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 75115 0
Australia
Phone 75115 0
+61 (3) 9905 1415
Fax 75115 0
Email 75115 0
[email protected]
Contact person for scientific queries
Name 75116 0
Margaret Murray
Address 75116 0
Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 75116 0
Australia
Phone 75116 0
+61 (3) 9905 1415
Fax 75116 0
Email 75116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As described in the ethics application, only grouped de-identified data will be made available to the public.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1595Study protocol    https://bmjopen.bmj.com/content/8/12/e022195



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for a double-blind randomised controlled trial investigating the impact of 12 weeks supplementation with a Fucus vesiculosus extract on cholesterol levels in adults with elevated fasting LDL cholesterol who are overweight or have obesity.2018https://dx.doi.org/10.1136/bmjopen-2018-022195
EmbaseTwelve weeks' treatment with a polyphenol-rich seaweed extract increased HDL cholesterol with no change in other biomarkers of chronic disease risk in overweight adults: A placebo-controlled randomized trial.2021https://dx.doi.org/10.1016/j.jnutbio.2021.108777
N.B. These documents automatically identified may not have been verified by the study sponsor.