Can seaweed supplementation reduce cardiovascular disease risk?

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12617001039370
• Date of registration: 17/07/2017
• Prospective Registration: Yes
• Primary sponsor: Monash University
• 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
• Date of first enrolment: 23/08/2017
• Target sample size: 58
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617001039370.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Margaret Murray

• Name: Dr Margaret Murray

Key inclusion & exclusion criteria

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
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)

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Alternative and Complementary Medicine - Other alternative and complementary medicine

Diet and Nutrition - Other diet and nutrition disorders

cardiovascular disease;hypercholesterolaemia;type 2 diabetes;
cardiovascular disease
hypercholesterolaemia
type 2 diabetes

Cardiovascular - Other cardiovascular diseases

Metabolic and Endocrine - Diabetes

Intervention(s)

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.

Primary Outcome(s)

Change in fasting LDL cholesterol level as assessed by automated analyser (Indiko).[Comparing baseline and 12 weeks post commencement of the intervention]

Secondary Outcome(s)

Assessment of participant compliance to the intervention as measured by check-off sheets and collection and counting of left-over capsules.[6 weeks and 12 weeks post commencement of the intervention]

Changes in fasting lipid profile (total cholesterol, HDL cholesterol, triglycerides) as assessed by automated analyser (Indiko).[Comparing baseline and 12 weeks post commencement of the intervention]

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)[6 weeks post commencement of the intervention]

Changes in inflammatory markers (including CRP and TNF-alpha) as assessed by plasma assay[Comparing baseline and 12 weeks post commencement of the intervention]

Changes in fasting glucose, as assessed by automated analyser (Indiko), and insulin, as assessed by ELISA.[Comparing baseline and 12 weeks post commencement of the intervention]

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)[Comparing baseline and 12 weeks post commencement of the intervention]

Investigation of early changes in fasting cholesterol levels as measured by automated analyser (Indiko)[6 weeks post commencement of the intervention]

Investigation of early changes in fasting glucose levels as measured by automated analyser (Indiko)[6 weeks post commencement of the intervention]

Secondary ID(s)

None

Source(s) of Monetary Support

Marinova Pty Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Monash University Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 12/03/2019
• Date Completed: 04/12/2018