Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001010381
Ethics application status
Approved
Date submitted
7/07/2017
Date registered
13/07/2017
Date last updated
26/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of a soluble seaweed dietary fibre on gut, metabolic and skin health.
Scientific title
In an overweight population, does the addition of soluble seaweed dietary fibres to the diet change the overall gut function and microbiome, metabolic and inflammatory skin conditions?
Secondary ID [1] 292167 0
CT-2017-CTN-02425-1 v1
Universal Trial Number (UTN)
U1111-1197-7084
Trial acronym
BIOBELLY 2
Linked study record
ACTRN12615001057572

Health condition
Health condition(s) or problem(s) studied:
Poor gut health 303609 0
Increased Chronic Inflammation 303610 0
Impaired Glucose Tolerance and Insulin resistance 303611 0
Dyslipidaemia 303612 0
Keratoderma/psoriatic skin condition 303971 0
Condition category
Condition code
Oral and Gastrointestinal 303021 303021 0 0
Normal oral and gastrointestinal development and function
Metabolic and Endocrine 303022 303022 0 0
Normal metabolism and endocrine development and function
Inflammatory and Immune System 303023 303023 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a phase 2 clinical trial building upon Biobelly, the phase 1 pilot trial (ACTRN 12615001057572). This is the second human study for the intervention of soluble dietary fibre from seaweed. Participants will be recruited and randomly assigned in a cross over design to 2g or placebo controlled group for soluble extract from seaweed . This is to be ingested daily for 6 weeks and blood and faecel samples will be tested before and after the intervention. Then participants will be crossed to the other treatment arm for a further 6 week intervention, with blood and faecal samples tested again after the second 6 week intervention. Therefore each study participant will be giving blood and faecal samples at 3 time points 6 weeks apart. There is no washout period between the 2 interventions as this is unnecessary. Participants are provided with a calendar sheet to provide daily adherence. Participants will receive more than the requisite amounts of supplements, this will vary accross participants and any unused supplements will be returned at the end of each 6 week intervention period. The record of intake (calendar) and the left over supplements will be monitored as a measure of compliance.
Intervention code [1] 298321 0
Prevention
Intervention code [2] 298573 0
Treatment: Other
Comparator / control treatment
The comparator is milled brown rice flour.
Control group
Placebo

Outcomes
Primary outcome [1] 302392 0
Changes in participants lipid profile, measured using plasma total cholesterol, non-HDL cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.
Timepoint [1] 302392 0
Baseline and 6 weeks post intervention, and week 12 post second treatment arm intervention.
Primary outcome [2] 302393 0
Changes in inflammatory markers, measured in plasma and including markers such as C-reactive protein, Interleukin 6, Interleukin 8 and Tumor necrosis factor alpha.
Timepoint [2] 302393 0
Baseline and 6 weeks post intervention, and week 12 post second treatment arm intervention.
Secondary outcome [1] 335823 0
Changes in carbohydrate metabolism. This is measured by assessing plasma levels of: fasting glucose, insulin and insulin like growth factor 1, and the 2 hour glucose and insulin response to the oral glucose tolerance test using assays.
Timepoint [1] 335823 0
Baseline and 6 weeks post intervention, and week 12 post second treatment arm intervention.
Secondary outcome [2] 335824 0
Changes in gut micobiome composition and diversity as determined by 16S rRNA sequencing and whole genome sequencing, both measured using stool sample swabs.
Timepoint [2] 335824 0
Baseline and 6 weeks post intervention, and week 12 post second treatment arm intervention.
Secondary outcome [3] 335825 0
To confirm the safety of supplementation. This is measured by assessing levels of interleukin 6 and tumor necrosis factor alpha in plasma, as a measure of liver and kidney function, using assays.
Timepoint [3] 335825 0
Baseline and 6 weeks post intervention, and week 12 post second treatment arm intervention.
Secondary outcome [4] 335828 0
Changes in palmoplantar keratoderma associated quality of life, as assessed by the Palmoplantar Quality of Life Instrument and the Dermatology Life Quality Index.
Timepoint [4] 335828 0
Baseline and 6 weeks post intervention, and week 12 post second treatment arm intervention.
Secondary outcome [5] 336796 0
Changes in psoriatic associated quality of life, as assessed by the Dermatology Life Quality Index.
Timepoint [5] 336796 0
Baseline and 6 weeks post intervention, and week 12 post second treatment arm intervention.
Secondary outcome [6] 336855 0
Changes in palmoplantar keratoderma symptom severity as assessed by the Visual Analogue Scale and the Psoriasis Area Severity Index. Photographs of the condition will be taken for visual comparison.
Timepoint [6] 336855 0
Baseline and 6 weeks post intervention, and week 12 post second treatment arm intervention.
Secondary outcome [7] 336856 0
Changes in psoriatic symptom severity as assessed by The Visual Analogue Scale and the Psoriasis Area Severity Index. Photographs of the condition will be taken for visual comparison.
Timepoint [7] 336856 0
Baseline and 6 weeks post intervention, and week 12 post second treatment arm intervention.

Eligibility
Key inclusion criteria
People with an overweight BMI (25-<30)
and/or people with a keratoderma or psoriatic skin condition
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People without an overweight BMI (<25 or >/= 30) or no keratoderma or psoriatic skin condition.
People who have recently been treated with antibiotics (last month) or who are currently on antibiotics.
People with very high blood pressure, very high glucose sensitivity, severe digestive conditions such as IBS and Chron's disease. People with 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)
The two boxed treatments are allocated a code A or B by an independent person.
Numbers 1-80 are randomised using statistical randomisation software and allocated to treatment A or B, treatment jars are then labelled with the same numbers by the independent person.
The excel spread sheet 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.
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 1-80 which will be allocated to two treatments. The software used is http://www.randomization.com/ as advised by the University of Wollongong Statistical Consultancy Service.
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
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size calculation was completed using the data from Biobelly our pilot trial. Using a two sided test, with 80% power and an alpha level of 0.05 we calculated that 30 people per group would be sufficient to obtain significant results for our plasma lipid measures. However, because we may encounter participants dropping out during the study period we will recruit up to a maximum of 80 participants to ensure the study is adequately powered.

The statistical methods used for our study data include t tests to determine the difference between our two treatment groups and the difference in the change of study outcomes between the two groups.
Gut microbiome data will be analysed using multivariate permanova.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2017
Actual
3/08/2017
Date of last participant enrolment
Anticipated
4/08/2017
Actual
5/09/2017
Date of last data collection
Anticipated
24/11/2017
Actual
7/12/2017
Sample size
Target
80
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 16403 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 296703 0
Commercial sector/Industry
Name [1] 296703 0
Venus Shell Systems Pty Ltd
Country [1] 296703 0
Australia
Funding source category [2] 296704 0
University
Name [2] 296704 0
University of Wollongong
Country [2] 296704 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave
North Wollongong
NSW 2500
Country
Australia
Secondary sponsor category [1] 295661 0
None
Name [1] 295661 0
Address [1] 295661 0
Country [1] 295661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297932 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 297932 0
Research Services Office
Building 20, Level 1
University of Wollongong,
Northfields Ave
Wollongong NSW 2522
Ethics committee country [1] 297932 0
Australia
Date submitted for ethics approval [1] 297932 0
13/03/2017
Approval date [1] 297932 0
04/07/2017
Ethics approval number [1] 297932 0
2017/101

Summary
Brief summary
The aim of this project is to test the effectiveness of a seaweed dietary fibre extract on gut and metabolic health and, consequential effects on inflammatory related Palmoplantar / psoriatic Keratoderma symptoms. This study will follow the initial Bio-Belly Study 1, where we have already found significant outcomes in an overweight population. Improvements were seen in plasma cholesterol, inflammation and insulin, as well as a case study, anecdotal improvement to a psoriatic skin disorder. Therefore, we aim to demonstrate repeated efficacy of the seaweed extract in an independent sample population, and to increase the power by restricting it to overweight participants only, and not obese, as there was a larger effect size in the overweight population. In addition, we would like to recruit to test the anecdotal effect of improvement to psoriatic skin disorders found in the initial trial. We propose to undertake a randomised placebo controlled crossover trial, with two six week treatment arms. Therefore the trial in its entirety will last 12 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75494 0
Prof Barbara Meyer
Address 75494 0
School of Medicine
University of Wollongong
Northfields Ave
North Wollongong NSW 2522
Country 75494 0
Australia
Phone 75494 0
+61242213459
Fax 75494 0
Email 75494 0
[email protected]
Contact person for public queries
Name 75495 0
Lauren Roach
Address 75495 0
School of Medicine
University of Wollongong
Northfields Ave
North Wollongong NSW 2522
Country 75495 0
Australia
Phone 75495 0
+61437303722
Fax 75495 0
Email 75495 0
[email protected]
Contact person for scientific queries
Name 75496 0
Pia Winberg
Address 75496 0
220 Bolong Rd
Bomaderry NSW 2541
Country 75496 0
Australia
Phone 75496 0
+61429338846
Fax 75496 0
Email 75496 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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