ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

cardiovascular disease

hypercholesterolaemia

type 2 diabetes

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Cardiovascular

Other cardiovascular diseases

Metabolic and Endocrine

Diabetes

Alternative and Complementary Medicine

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]

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]

Change in fasting LDL cholesterol level as assessed by automated analyser (Indiko).

Timepoint [1]

Comparing baseline and 12 weeks post commencement of the intervention

Secondary outcome [1]

Changes in fasting lipid profile (total cholesterol, HDL cholesterol, triglycerides) as assessed by automated analyser (Indiko).

Timepoint [1]

Comparing baseline and 12 weeks post commencement of the intervention

Secondary outcome [2]

Changes in fasting glucose, as assessed by automated analyser (Indiko), and insulin, as assessed by ELISA.

Timepoint [2]

Comparing baseline and 12 weeks post commencement of the intervention

Secondary outcome [3]

Changes in inflammatory markers (including CRP and TNF-alpha) as assessed by plasma assay

Timepoint [3]

Comparing baseline and 12 weeks post commencement of the intervention

Secondary outcome [4]

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]

Comparing baseline and 12 weeks post commencement of the intervention

Secondary outcome [5]

Assessment of participant compliance to the intervention as measured by check-off sheets and collection and counting of left-over capsules.

Timepoint [5]

6 weeks and 12 weeks post commencement of the intervention

Secondary outcome [6]

Investigation of early changes in fasting cholesterol levels as measured by automated analyser (Indiko)

Timepoint [6]

6 weeks post commencement of the intervention

Secondary outcome [7]

Investigation of early changes in fasting glucose levels as measured by automated analyser (Indiko)

Timepoint [7]

6 weeks post commencement of the intervention

Secondary outcome [8]

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]

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]

Commercial sector/Industry

Name [1]

Marinova Pty Ltd

Address [1]

249 Kennedy Drive, Cambridge TAS 7170

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University Clayton Campus, Wellington Road, Clayton VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/05/2017

Approval date [1]

08/05/2017

Ethics approval number [1]

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

A/Prof Maxine Bonham

Address

Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168

Country

Australia

Phone

+61 3 9902 4272

Fax

Email

maxine.bonham@monash.edu

Contact person for public queries

Name

Margaret Murray

Address

Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168

Country

Australia

Phone

+61 (3) 9905 1415

Fax

Email

margaret.murray@monash.edu

Contact person for scientific queries

Name

Margaret Murray

Address

Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168

Country

Australia

Phone

+61 (3) 9905 1415

Fax

Email

margaret.murray@monash.edu

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.	Type	Citation	Link	Email	Other Details	Attachment
1595	Study 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

Source	Title	Year of Publication	DOI
Embase	Study 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.	2018	https://dx.doi.org/10.1136/bmjopen-2018-022195
Embase	Twelve 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.	2021	https://dx.doi.org/10.1016/j.jnutbio.2021.108777

N.B. These documents automatically identified may not have been verified by the study sponsor.