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Trial registered on ANZCTR


Registration number
ACTRN12614000495628
Ethics application status
Approved
Date submitted
5/05/2014
Date registered
12/05/2014
Date last updated
28/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Fucoidan on glucose control and markers of cardiometabolic health after chronic dosing
Scientific title
In an obese, non-diabetic population, does twice daily dosing of a commercially available fucoidan extract over three months, when compared to placebo, lead to changes in glucose control and other markers of cardiometabolic health?
Secondary ID [1] 284488 0
Nil
Universal Trial Number (UTN)
U1111-1156-5012
Trial acronym
Linked study record

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



291730 0
Hyperlipidaemia 291731 0
Hypercholesterolaemia 291732 0
Insulin Resistance/sensitivity 291733 0
Glucose tolerance 291736 0
Obesity 291821 0
Condition category
Condition code
Metabolic and Endocrine 292103 292103 0 0
Diabetes
Metabolic and Endocrine 292104 292104 0 0
Metabolic disorders
Cardiovascular 292105 292105 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm One: Participants will be asked to take ONE capsule twice daily, for 3 months, of a commercially available seaweed extract (Maritech Synergy) equivalent to 500mg of fucoidan per capsule. This product is classified as a dietary supplement. Participants will attend one screening appointment to assess eligibility. If eligible, participants will be asked to attend another appointment (called study appointment one) to provide written and informed consent, be randomly allocated to arm 1 or arm 2 of the study and take baseline measurements: blood pressure, height, weight, waist circumference, fasting blood glucose, HBA1c, insulin, lipid profile, liver, kidney and blood system function tests. At this point participants will also be asked to provide information on current medical conditions and medications. Participants will be provided with a 75g in 125mL sucrose (sugar) drink and measurements taken at set time points over two hours following the drink. Adherence will be encouraged through fortnightly phone calls (as far as practicable). A follow up appointment will be made at the end of the 3 month course of capsules, with the procedure identical to study appointment one, barring written and informed consent which will have already been obtained. Participants will be asked to inform researchers of any changes to medical conditions, medications, exercise habits, diet and alcohol intake over the previous three months, during this appointment. Adherence to treatment will be checked through capsule counting and patient self-report ("How many times have you missed a dose in the past week?") at the conclusion of the trial.
Intervention code [1] 289245 0
Treatment: Other
Comparator / control treatment
Arm 2: Procedures are identical to arm 1 except that participants will be provided with placebo capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 291981 0
Insulin sensitivity - calculated through the HOMA (primary measure) and quantitative insulin sensitivity check index (QUICKI) scores.
Timepoint [1] 291981 0
After three months of dosing.
Secondary outcome [1] 307955 0
Fasting blood glucose and HBA1c (a measure of glucose control, generally over the preceding 3 months). Both tests assessed through fasting venous blood sample.
Timepoint [1] 307955 0
After three months of dosing.
Secondary outcome [2] 307956 0
Glucose tolerance. Assessed through repeated blood glucose measurements (with a handheld glucometer) following participants drinking a sucrose (sugar) drink.
Timepoint [2] 307956 0
After three months of dosing.
Secondary outcome [3] 307957 0
Lipid profile - including total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides. Assessed through a fasting venous blood sample (total cholesterol level, HDL, LDL and triglyceride asssay).
Timepoint [3] 307957 0
After three months dosing.
Secondary outcome [4] 307958 0
Liver, kidney and blood system function. Assessed through a urea, electrolyte and creatinine (UEC) test, a liver function test and a full blood picture (from a fasting venous blood sample).

Timepoint [4] 307958 0
After three months of dosing.
Secondary outcome [5] 307959 0
Weight, waist circumference and body mass index (BMI)
Timepoint [5] 307959 0
After three months of dosing.

Eligibility
Key inclusion criteria
Body mass index >= 30 mg/m^2
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diabetes or family history of diabetes (parents or siblings)
- Current smokers (participants that have smoked previously may be included, though not if they have had any cigarettes in the past 30 days or if they smoke during the study period of 3 months).
- Random blood glucose level above 7.8mM (during screening appointment).
- Fasting blood glucose level above 7mM at either study appointment.
- Taking more than 5 regular medicines.
- Taking any anticoagulant medication.
- Having any contraindication to anticoagulant medication (e.g. increased risk of bleeding due to a medical condition).

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)
Participant will be pre-screened over the phone, attend a formal screening appointment followed by two study appointments; one at the beginning and another at the end of the trial.

Allocation is concealed via central randomisation.

Participants will not be aware of whether they have been allocated to arm 1 or arm 2 of the trial. The investigators will also be unaware of participants treatment allocation when the decision to enrol participants is made and will be blinded to allocation (arm 1 or arm 2) when participants are randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size estimated based on literature data for insulin sensitivity (using HOMA score) that: the mean HOMA index for normal healthy individuals (without diabetes or impaired glucose tolerance) is 2.0 (standard deviation = 0.8), and that fucoidan reduces this figure by at least a mean of 20%.

Based on these assumptions, 34 patients are needed (at a power of 80% and P = 0.05) to show statistical significance. Therefore 40 participants per arm will be recruited (N = 80 in total) to allow for a 15% drop-out rate during the trial.

Data will be analysed using a statistical program such as SPSS and data will be input into a database during the trial to allow comparison between study appointment one and two and/or between participants in arm 1 and arm 2.

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 8027 0
7005 - University Of Tasmania

Funding & Sponsors
Funding source category [1] 289133 0
Commercial sector/Industry
Name [1] 289133 0
Marinova Pty Ltd.
Address [1] 289133 0
249 Kennedy Drive
Cambridge TAS 7170
Australia
Country [1] 289133 0
Australia
Primary sponsor type
University
Name
University of Tasmania.
Address
Private Bag 26, Hobart TAS 7001
Country
Australia
Secondary sponsor category [1] 287878 0
None
Name [1] 287878 0
Address [1] 287878 0
Country [1] 287878 0
Other collaborator category [1] 277924 0
Commercial sector/Industry
Name [1] 277924 0
Marinova Pty Ltd.
Address [1] 277924 0
249 Kennedy Drive
Cambridge TAS 7170
Australia
Country [1] 277924 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290911 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 290911 0
Private Bag 1, Hobart TAS 7001
Ethics committee country [1] 290911 0
Australia
Date submitted for ethics approval [1] 290911 0
Approval date [1] 290911 0
01/04/2014
Ethics approval number [1] 290911 0
H0013608

Summary
Brief summary
This study is looking to assess if a commercially available seawead extract (fucoidan) has an effect on blood sugar and insulin levels, as well as other markers of cardio (heart) and metabolic health, when taken over three months. To allow us to assess its impact, one half (approx 40) of the enrolled participants will take a placebo capsule which does not contain fucoidan or any other active ingredient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47934 0
Prof Gregory Peterson
Address 47934 0
Division of Pharmacy, School of Medicine
University of Tasmania
Private Bag 26, Hobart TAS 7001
Country 47934 0
Australia
Phone 47934 0
+613 6226 2197
Fax 47934 0
+613 6226 2870
Email 47934 0
gregory.peterson@utas.edu.au
Contact person for public queries
Name 47935 0
Prof Gregory Peterson
Address 47935 0
Division of Pharmacy, School of Medicine
University of Tasmania
Private Bag 26, Hobart TAS 7001
Country 47935 0
Australia
Phone 47935 0
+613 6226 2197
Fax 47935 0
+613 6226 2870
Email 47935 0
gregory.peterson@utas.edu.au
Contact person for scientific queries
Name 47936 0
Prof Gregory Peterson
Address 47936 0
Division of Pharmacy, School of Medicine
University of Tasmania
Private Bag 26, Hobart TAS 7001
Country 47936 0
Australia
Phone 47936 0
+613 6226 2197
Fax 47936 0
+613 6226 2870
Email 47936 0
gregory.peterson@utas.edu.au

No information has been provided regarding IPD availability
Summary results
No Results