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Trial registered on ANZCTR


Registration number
ACTRN12616000126415
Ethics application status
Approved
Date submitted
27/01/2016
Date registered
4/02/2016
Date last updated
20/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a seaweed supplement reduce your risk of diabetes?
Scientific title
Investigation of the impact of a polyphenol-rich seaweed extract on postprandial glycaemic control in healthy adults.
Secondary ID [1] 288420 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial glycaemic response 297436 0
Diabetes 297464 0
Condition category
Condition code
Metabolic and Endocrine 297622 297622 0 0
Diabetes
Alternative and Complementary Medicine 297653 297653 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The test product is Maritech (Registered Trademark) Synergy, an extract from the macroagla Fucus vesiculosus that contains 30% polyphenols and 60% fucoidan (a complex carbohydrate). The product will be encapsulated for ease of consumption and dosing. Doses of 500 mg (150 mg polyphenols) and 2000 mg (600 mg polyphenols) will be administered on a single occasion prior to an oral glucose tolerance test.

Participants will be provided with a standardised commercially available frozen meal to consume between 7 - 9 pm the night before each testing day, then will be asked to fast until testing is complete, drinking only water. Participants are also asked to avoid foods high in polyphenols and strenuous exercise for 24 hours prior to testing. Participants will be asked to come in to the lab at 7 am in the morning following an overnight fast. They will have two initial finger prick tests done to provide fasting levels of blood glucose and insulin (at -45 and -30 minutes), then be given either a low (500 mg) or high (2000 mg) dose of marine polyhpenol supplement. At 0 minutes they will be provided with a 50 g available carbohydrates from bread, which must be consumed within 5 minutes.

Following completion of the three morning cross overs (high dose, low dose, placebo), all participants will have the option to continue to partake in the evening arm of the study. Participants who choose to complete the evening protocol as well will have a wash out period between the two arms of at least 3 days. Participants will be randomized as to the order they will consume the placebo and 2000 mg dose of the test product, in a 2-way cross-over. The same protocol as for the mornings will be carried out for evening testing, but with participants consuming a standardised commercially available frozen meal between 7 and 8 am and arriving at the testing facility at 6 pm after fasting throughout the day.

Participants will consume the test doses and placebo in a cross-over fashion with at least three days washout in between each treatment. All treatment doses will be administered and supervised on site.
Intervention code [1] 293734 0
Prevention
Intervention code [2] 293735 0
Treatment: Other
Comparator / control treatment
The product acting as the placebo is Medisca (Registered Trademark) Cellulose, NF (Microcrystalline). It will be administered in a dose of 2000 mg to match the high dose intervention product and will also be encapsulated.
Control group
Placebo

Outcomes
Primary outcome [1] 297166 0
Postprandial blood glucose incremental area under the curve
Timepoint [1] 297166 0
Blood samples taken at -45, -30, 15, 30, 45, 60, 90 and 120 minutes after test drink.
Primary outcome [2] 297167 0
Postprandial blood insulin incremental area under the curve
Timepoint [2] 297167 0
Blood samples taken at -30, 30, 60, 90 and 120 minutes after test drink.
Secondary outcome [1] 320212 0
Postprandial blood glucose 'time to peak'
Timepoint [1] 320212 0
Blood samples taken at -45, -30, 15, 30, 45, 60, 90 and 120 minutes after test drink.
Secondary outcome [2] 320213 0
Postprandial blood insulin 'time to peak'
Timepoint [2] 320213 0
Blood samples taken at -30, 30, 60, 90 and 120 minutes after test drink.
Secondary outcome [3] 320214 0
How timing of supplementation, whether administered in the morning (~7 am) or evening (~6 pm), affects polyphenol impact on postprandial blood glucose and insulin incremental area under the curve and 'time to peak'.
Timepoint [3] 320214 0
Blood samples taken at -45, -30, 15, 30, 45, 60, 90 and 120 minutes after test drink for glucose.
Blood samples taken at -30, 30, 60, 90 and 120 minutes after test drink for insulin.
Secondary outcome [4] 320215 0
Intolerance symptoms - assessed by participant completion of a questionnaire designed specifically for this study.
Timepoint [4] 320215 0
24 hours from supplement ingestion

Eligibility
Key inclusion criteria
Body mass index from 18.5 to less than 28 kg/m2, a fasting blood glucose level below 5.5 mmol/L and blood pressure within the normal range.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Gastrointestinal issues that may affect the absorption and intestinal actions of the polyphenols,
2. Taking medication for blood sugar control,
3. Taking other natural health products known to impact on polyphenols e.g. fish oil,
4. Breastfeeding or pregnant,
5. Have any of the following serious health conditions:
i. liver/thyroid issues,
ii. hypertension,
iii. recent major surgery,
6. Consume more than 4 standard drinks per day, or 9 standard drinks per week,
7. Smoker,
8. Have an implanted cardiac defibrillator.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The researcher conducting participant allocation will be separate from the researcher conducting participant screening and allocation will remain hidden from the researcher doing the screening in a secure computer database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation will be used to determine the order in which participants receive each treatment.
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Forty individuals will be recruited with the expectation that at least 36 will complete the whole protocol, which allows for a dropout rate of 10%. Sample size calculations were performed, assuming 2-sided 0.80 power, with 0.05 significance level, to detect a change of 40 units in postprandial blood glucose iAUC and a change of 2500 units in postprandial plasma insulin iAUC,. Sample size calculations were based on data from similar studies that also examined these outcomes.

All results will be assessed for normality. Paired t-tests will be used to compare the difference between intervention and placebo groups for blood glucose and insulin iAUC and blood glucose and insulin time to peak. Descriptive statistics (number and percentages) will be used to interpret intolerance symptoms.

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 in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292768 0
Commercial sector/Industry
Name [1] 292768 0
Marinova Biotechnology Company
Address [1] 292768 0
249 Kennedy Drive,
Cambridge 7170
TAS
Country [1] 292768 0
Australia
Primary sponsor type
University
Name
Monash University, Department of Nutrition and Dietetics
Address
Level 1, 264 Ferntree Gully Rd,
Notting Hill 3168, VIC
Country
Australia
Secondary sponsor category [1] 291534 0
None
Name [1] 291534 0
None
Address [1] 291534 0
None
Country [1] 291534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294259 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 294259 0
Monash University
Room 111, Chancellery Building E
24 Sports Walk
Clayton Campus
Wellington Rd
Clayton VIC 3800
Ethics committee country [1] 294259 0
Australia
Date submitted for ethics approval [1] 294259 0
06/01/2016
Approval date [1] 294259 0
16/02/2016
Ethics approval number [1] 294259 0
CF16/53 - 2016000019

Summary
Brief summary
Type 2 diabetes is increasing worldwide and can cause serious health complications if left uncontrolled. In 2014 it was estimated that 9% of the global adult population suffered from diabetes, of which 90% could be attributed to type 2 diabetes. Optimal blood glucose control reduces the risk of diabetes-related complications. There are currently a number of drugs on the market to control blood sugar levels; however they produce unpleasant side effects. Marine polyphenols have shown potential to improve blood glucose control without producing side effects.

While polyphenols are found in both terrestrial plants and marine algae, this study will focus solely on those commercially available from marine sources. Marine polyphenols, or phlorotannins, are most commonly found in brown algae. There are a number of advantages to cultivating marine algae compared with terrestrial plants, and marine-derived compounds are rapidly growing in popularity in the food industry, especially with the current consumer preference for natural health products over synthetic ones.

There is promising research regarding the antidiabetic effects of marine polyphenols in animal and in vitro studies. However, it is yet to be determined if the same health effects are consistently true in a human population. If so, marine polyphenols may be useful for controlling blood sugar levels, resulting in fewer side effects and a reduced risk of complications for people with type 2 diabetes. Marine polyphenols may also be useful for people with prediabetes to lower blood sugar levels and prevent progression to type 2 diabetes.

This study aims to:
1. Determine the effect of commercially available doses of marine polyphenols in supplement form on postprandial blood glucose and insulin following a glucose load, compared to placebo in a human population.

2. Determine how well different doses of polyphenols are accepted through completion of an intolerance symptoms questionnaire.

3. Examine the effects of commercially available doses (Marinova) of marine polyphenols in supplement form on changes in blood glucose and insulin following a glucose load, in the evening. Blood glucose rises higher and stays high for longer following consumption of carbohydrates in the evening, compared to the morning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63078 0
A/Prof Maxine Bonham
Address 63078 0
Monash University
Be Active Sleep Eat Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 63078 0
Australia
Phone 63078 0
+61 3 9902 4272
Fax 63078 0
Email 63078 0
maxine.bonham@monash.edu
Contact person for public queries
Name 63079 0
A/Prof Maxine Bonham
Address 63079 0
Monash University
Be Active Sleep Eat Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 63079 0
Australia
Phone 63079 0
+61 3 9902 4272
Fax 63079 0
Email 63079 0
maxine.bonham@monash.edu
Contact person for scientific queries
Name 63080 0
A/Prof Maxine Bonham
Address 63080 0
Monash University
Be Active Sleep Eat Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 63080 0
Australia
Phone 63080 0
+61 3 9902 4272
Fax 63080 0
Email 63080 0
maxine.bonham@monash.edu

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