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Trial registered on ANZCTR


Registration number
ACTRN12615001057572
Ethics application status
Approved
Date submitted
22/09/2015
Date registered
12/10/2015
Date last updated
12/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of a soluble seaweed dietary fibre on wellness, gut flora and metabolism.
Scientific title
In a population with a typical western diet and high BMI, does the addition of soluble seaweed dietary fibres to the diet change the overall gut function and microbiome structure?
Secondary ID [1] 287518 0
TGA CTN CT2015CTN021221 v1
Universal Trial Number (UTN)
U1111-1174-7727
Trial acronym
BIOBELLY

Biological Investigation Of Bowel Effects and Lowering Lipids for Your health from Seaweed.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Digestive health 296279 0
Oxidative stress 296280 0
Inflammatory status 296281 0
glucose tolerance 296282 0
Condition category
Condition code
Oral and Gastrointestinal 296557 296557 0 0
Normal oral and gastrointestinal development and function
Metabolic and Endocrine 296558 296558 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a first human pilot study for the intervention of soluble dietary fibre from seaweed. Participants will be recruited and randomly assigned to a 4g, 2g or placebo control group for soluble extract from seaweed. This is to be ingested daily for 6 weeks and blood, urine and faeces samples will be tested before and after the intervention.
Participants are provided a magnetic fridge tick list to record daily adherence and will return supplement containers that had been stocked with recorded random numbers of capsules prior to intervention.
Intervention code [1] 292917 0
Prevention
Comparator / control treatment
The comparator is a lack of complex soluble dietary fibres in a normal western diet. The Placebo comparator used is milled white rice flour. White rice being very low in both soluble and insoluble dietary fibres (Prosky, L., N. G. Asp, T. F. Schweizer, J. W. DeVries and I. Furda (1988). "Determination of insoluble, soluble, and total dietary fiber in foods and food products: interlaboratory study." Journal - Association of Official Analytical Chemists 71(5): 1017-1023.)
Control group
Placebo

Outcomes
Primary outcome [1] 296182 0
Percentage of participants on active treatments that display improved glucose tolerance test as well as insulin and C-peptides in blood serum as a composite primary outcome of pre-diabetic status.
Timepoint [1] 296182 0
Baseline and at 6 weeks post-intervention
Primary outcome [2] 296183 0
Changes to composite microbial function from a combination of microflora profile using Next Gen Sequencing of faecal swabs.
Timepoint [2] 296183 0
Baseline and at 6 weeks post-intervention
Primary outcome [3] 296184 0
Changes to oxidative stress markers using f2-isoprostane analysis of 24 hour urine samples.
Timepoint [3] 296184 0
Baseline and at 6 weeks post-intervention
Secondary outcome [1] 317728 0
Changes to blood endotoxin levels in plasma using colorimetric methods.
Timepoint [1] 317728 0
Baseline and at 6 weeks post-intervention
Secondary outcome [2] 317729 0
Changes to cholesterol profile will be tested in blood plasma for HDL, Total Cholesterol and Triglycerides.
Timepoint [2] 317729 0
Baseline and at 6 weeks post-intervention
Secondary outcome [3] 317963 0
Changes to inflammatory marker CRP in blood serum.
Timepoint [3] 317963 0
Baseline and at 6 weeks post-intervention
Secondary outcome [4] 317964 0
Changes to Ghrelin content in blood plasma as an indicator of reduced eating trigger as well as a new indicator of reduced endotoxin presence and/or reduced inflammatory status. This is a colourimetric assay.
Timepoint [4] 317964 0
Baseline and at 6 weeks post-intervention
Secondary outcome [5] 317966 0
Changes to wellness questionaire scores from Questionnaire SF-36 Australian version 31Aug2009.
Timepoint [5] 317966 0
Baseline and at 6 weeks post-intervention

Eligibility
Key inclusion criteria
Overweight (BMI>24) individuals consuming an average western diet (as identified by K:Na ratio in 24hr urine and the initial record of 3 random 24hr dietary intakes). Presence of mild gut health concerns are allowed but not a requirement.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI<24
Concerning indications of very high blood pressure (as measured during recruitment or self diagnosed)
Very high glucose sensitivity
Medication of antibiotics (participants may finish with a shorter intervention if antibiotics are required)
Any other severe digestive conditions such as IBS or Chrons disease.
Coronary Heart Disease

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)
Subjects are recruited with a personal identifier following an invitation brochure and/or seminar about the study.
The three blinded treatments are allocated a code A, B or C in 3 boxes.
Numers 1-60 are randomised using a statistical randomisation software as advised by the University School of Mathematics.
The random numbers are allocated to treatments A, B and C and labelled on jars as 1-60, by an independent University Researcher.
The Excel spreadsheet with the treatment key is printed and locked in 3 independent files at the University of Wollongong.
The jars are sorted in numerical order and provided to the participants as they sign up to the project.
An additional 20 subjects taking seaweed food products will not be blinded bringing the total number of participants to 80.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This project uses a simple randomisation to generate a sequence of numbers 1-60 which will be allocated to three treatments. The software used is http://www.randomization.com/
There are no blocks or strata in this Phase I trial.
An additional 20 participants will be recruited but not blinded and will consume whole seaweed food products as a comparison to the extract.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Multivariate Permanova - non-parametric for multiple variables
1-way Analysis of Variance - parametric for specific variables

Recruitment
Recruitment status
Not yet 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)
NSW
Recruitment postcode(s) [1] 10602 0
2540 - Mundamia

Funding & Sponsors
Funding source category [1] 292094 0
Commercial sector/Industry
Name [1] 292094 0
Venus Shell Systems Pty Ltd
Address [1] 292094 0
c/o University of Wollongong Shoalhaven Campus
George Evans Rd
Mundamia
NSW 2540
Country [1] 292094 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave
North Wollongong
NSW 2522
Country
Australia
Secondary sponsor category [1] 290773 0
None
Name [1] 290773 0
Address [1] 290773 0
Country [1] 290773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293581 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 293581 0
c/o University of Wollongong
Research Services Office
Northfields Ave
North Wollongong
NSW 2522
Ethics committee country [1] 293581 0
Australia
Date submitted for ethics approval [1] 293581 0
08/04/2014
Approval date [1] 293581 0
22/09/2015
Ethics approval number [1] 293581 0
EC00150

Summary
Brief summary
We are undertaking one of the first seaweed dietary fibre and food ingredient studies on people with gut health concerns. The onset of chronic health disorders such as Type II Diabetes Mellitus are potentially related to reduced gut health. If seaweed dietary fibres can help improve the gut condition then it may be one option for preventing diabetic and other growing health concerns related to the gut.
Previous research in other laboratory studies and in animal trials with seaweed dietary fibres, have shown significant reductions in inflammation, glucose & insulin stress, as well as positive shifts in gut flora composition. Despite the well-established evidence for the safety of consumption of the identified seaweeds and their dietary fibre extracts, very few studies have investigated the health outcomes in human trials. We will test if an Australian species seaweed, dietary-fibre extract and food ingredient can help the gut health condition, as well as assess changes to blood health indices and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60514 0
A/Prof Barbara Meyer
Address 60514 0
School of Medicine
University of Wollongong
Northfields Ave
North Wollongong NSW 2522
Country 60514 0
Australia
Phone 60514 0
+61242213459
Fax 60514 0
Email 60514 0
bmeyer@uow.edu.au
Contact person for public queries
Name 60515 0
Dr Pia Winberg
Address 60515 0
c/o UOW Shoalhaven Campus
George Evans Rd
Mundamia
NSW 2540
Country 60515 0
Australia
Phone 60515 0
+61429338846
Fax 60515 0
Email 60515 0
pia@uow.edu.au
Contact person for scientific queries
Name 60516 0
Dr Pia C Winberg
Address 60516 0
c/o UOW Shoalhaven Campus
George Evans Rd
Mundamia
NSW 2540
Country 60516 0
Australia
Phone 60516 0
+61429338846
Fax 60516 0
Email 60516 0
pia@uow.edu.au

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