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Trial registered on ANZCTR


Registration number
ACTRN12619001149156
Ethics application status
Approved
Date submitted
5/08/2019
Date registered
16/08/2019
Date last updated
11/02/2020
Date data sharing statement initially provided
16/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Vegetable Soup on the Gut Microbiome
Scientific title
Double-Blind, Randomised, Placebo-Controlled Trial to Determine the Effects of a Vegetable Soup on the Gut Microbiome of Healthy Volunteers with Low Dietary Fibre Consumption
Secondary ID [1] 298700 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low dietary fibre consumption 313664 0
Condition category
Condition code
Diet and Nutrition 312080 312080 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 312081 312081 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised into one of two treatment arms to consume either two different placebo (Arm 1) or two different test soups (Arm 2) daily for two weeks. The serving size of each soup is 330 mL. Soups will be consumed orally in the participant’s location of preference e.g. at home or at work.

Soups are manufactured in convenient single-serve packaging and sourced primarily from natural, wholefood plant-based ingredients. No preservatives, additives, flavours or colours are added to the soups. The soups are heat-treated during production and sealed in pouches to maintain food safety and quality for the life of the product.

Being made from a variety of vegetables and herbs, the soups represent healthy dietary choices. The product recipes have been assessed by a qualified Dietitian (Dietitian Association of Australia accredited, DAA) for suitability for twice daily consumption for the duration of the two week study.

The soup production facility is a standard commercial food production facility that is SQF Certified for HACCP-based food safety. All ingredients are standard food grade ingredients. Food safety and quality checks are conducted in accordance with requirements for product destined for retail sale. Good Manufacturing Processes (GMP) are used, in accordance with the site quality and food safety systems. After cooking and packaging in hermetically sealed containers, the products are then subjected to standard food safety and quality analysis (pH, moisture, microbiological assessment) as appropriate to the product. All quality and safety parameters need to be met for the product to be used in the trial.

Packaging will be unbranded to minimise bias and include minimal information as is necessary for safety (product code, product storage instructions, allergen labelling etc). Prior to distribution to intervention subjects, the product will be stored in a manner that will ensure the product integrity and safety is maintained. The soups will be essentially suitable and legally fit for retail sale (with the addition of all mandatory retail labelling information).

Soup consumption will be monitored using a secure, online management platform ("Freedcamp"), in which participants will be required to acknowledge soup consumption during the study.
Intervention code [1] 315002 0
Treatment: Other
Intervention code [2] 315003 0
Lifestyle
Comparator / control treatment
The placebo group will consume unbranded soups which have identical packaging. The placebo treatment differs primarily in its decreased levels of dietary fiber, but still contains a variety of healthy, wholesome vegetable-based ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 320725 0
The primary outcome is changes in the gut microbiome using metagenomic DNA sequencing. This is a composite primary outcome, including the analysis of Shannon diversity (microbial diversity), relative abundance of specific microbial species and functional gene abundances.
Timepoint [1] 320725 0
0 weeks, 2 weeks.
Secondary outcome [1] 372617 0
Changes in blood biomarkers for metabolic health (lipids, glucose, HbA1c, fructosamine) using pathology laboratory blood analyses. This is a composite secondary outcome.
Timepoint [1] 372617 0
0 weeks, 2 weeks.
Secondary outcome [2] 372618 0
Changes in diet using Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. This is a composite outcome which will encompass changes in macronutrients, micronutrients and calories.
Timepoint [2] 372618 0
0 weeks, 2 weeks.

Eligibility
Key inclusion criteria
Adults of 18 to 65 years of age who consume low levels of dietary fibre.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a. Females who report pregnancy or lactating;
b. Gut-associated morbidities including irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), swallowing disorders and/or cancers;
c. Gut-associated medications in last 12 weeks: antibiotics, dietary fiber, prebiotics, probiotics and/or antacids;
d. Drugs that alter gut motility e.g. opiates, monoamine oxidase inhibitors, phenothiazines;
e. Surgery in last 12 weeks;
f. Food allergies and/or intolerances to soup ingredients e.g. FODMAPs.

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)
Third-party randomisation using encrypted online service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/08/2019
Actual
28/08/2019
Date of last participant enrolment
Anticipated
Actual
4/02/2020
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
48
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303294 0
Commercial sector/Industry
Name [1] 303294 0
Australian Health & Nutrition Association Limited
Country [1] 303294 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Australian Health & Nutrition Association Limited
Address
1 Sanitarium Road, Berkeley Vale, NSW 2261
Country
Australia
Secondary sponsor category [1] 303315 0
None
Name [1] 303315 0
Address [1] 303315 0
Country [1] 303315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303793 0
Bellberry Limited
Ethics committee address [1] 303793 0
Ethics committee country [1] 303793 0
Australia
Date submitted for ethics approval [1] 303793 0
05/07/2019
Approval date [1] 303793 0
28/08/2019
Ethics approval number [1] 303793 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94826 0
Dr Kylie Ellis
Address 94826 0
Microba Life Sciences, 12/388 Queen Street, Brisbane, QLD 4000
Country 94826 0
Australia
Phone 94826 0
+61 1300 974 621
Fax 94826 0
Email 94826 0
kylie.ellis@microba.com
Contact person for public queries
Name 94827 0
Kylie Ellis
Address 94827 0
Microba Life Sciences, 12/388 Queen Street, Brisbane, QLD 4000
Country 94827 0
Australia
Phone 94827 0
+61 1300 974 621
Fax 94827 0
Email 94827 0
kylie.ellis@microba.com
Contact person for scientific queries
Name 94828 0
Sherman Leung
Address 94828 0
Microba Life Sciences, 12/388 Queen Street, Brisbane, QLD 4000
Country 94828 0
Australia
Phone 94828 0
+61 1300 974 621
Fax 94828 0
Email 94828 0
sherman.leung@microba.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.