Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000451606
Ethics application status
Approved
Date submitted
11/04/2023
Date registered
2/05/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
2/05/2023
Date results information initially provided
16/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Acute Effect of Inulin and Non-Inulin based Fibres on Gut Transit Time and Metabolic Biochemistry on Healthy Adults: A Pilot Study on Fibres
Scientific title
The Acute Effect of Inulin and Non-Inulin based Fibres on Gut Transit Time and Metabolic Biochemistry on Healthy Adult: A Pilot Study on Fibres
Secondary ID [1] 309427 0
None
Universal Trial Number (UTN)
Trial acronym
The Fibres Study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Obesity
 329681 0
Cardiometabolic disorder 329682 0
Condition category
Condition code
Diet and Nutrition 326579 326579 0 0
Obesity
Cardiovascular 326580 326580 0 0
Other cardiovascular diseases
Metabolic and Endocrine 326634 326634 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot study aims to assess the acute effect of consuming inulin and non-inulin based dietary fibres. Inulin-based fibres including yacon, Jerusalem artichoke, globe artichoke, and Elephant garlic will be investigated alongside non-inulin-based fibres including apple, watermelon, orange and tomato. Throughout this study, both inulin and non-inulin fibres are referred as “test’ fibres.

This study involves two clinic visits, each lasting 8 hours. The first visit is the screening visit, and the second visit is the study clinic visit. During both clinic visits volunteers will be provided with a standardise meal plan that provides approximately one-third of their daily caloric intake from carbohydrates, protein, and fat. Volunteers will need to attend both clinic visits fasted for 8 hours. During the fasting period, the volunteers may take sip of water or continue to take their regular medications.

Diet: Volunteers may choose from either a vegetarian or meat-based standardised diet plan. For example , a standardised meat-based diet plan include toast with butter for breakfast, a chicken sandwich for lunch, roast chicken with potatoes for dinner, and crackers and cheddar cheese for snacks. In addition to the volunteers chosen standardize meal, volunteers will be provided up to three portions of the test fibres along with their breakfast. A portion of fibre is equivalent to the size of an average apple or a large globe artichoke. Volunteers may choose more than one test fibre but must have a gap of at least one week between each study clinic visit.

Screening visit: The researcher will explain the study protocol and answer any questions that the volunteers may have about the study. On the day before the volunteers attend the screening visit, volunteers will be asked to avoid high-fibre diets. At the screening visit, the researcher will check the volunteer’s eligibility. The researcher will provide a standardise diet plan along with 10g of inulin at breakfast.

A hydrogen breath test will be performed at baseline (i.e. before consuming 10g of inulin with breakfast) and then hourly for up to 8 hours. Individuals that show a sustained increase of exhaled hydrogen of > 20 ppm than baseline will be considered eligible to participate in the study.

If the volunteers are eligible, they will be given the option to choose which test fibres they would like to participate in and will be invited to attend a study clinic visit, at least one week later.

24hr before the study clinic visit: The volunteers will start following the standardised diet plan provided at home. They will also be asked to complete a food diary that includes information about any non-study foods that they have consumed, the number of caffeinated and alcoholic beverages that they have consumed, their physical activity, and any intake of medication. Volunteers will also need to provide their age, and gender in this food diary. They can complete this diary in the comfort of their own home.

Study Clinic Visit: At the clinic, the researchers will provide the standardise breakfast along with the volunteer’s test fibres.

The researcher will perform the following assay and specimen collections at baseline (i.e. before consumption of fibres) and then hourly for 8 hours.
1. A serial urine collection at designated times, ideally including before consumption of the fibres of interest (U1), within 2hrs after breakfast (U2); before lunch (U3); within 2hrs after lunch (U4), and at the end of the 8 hr (U5). If volunteers do not need to urinate so frequently, they can collect a urine specimen every time they urinate and document the time.
2. An hourly hydrogen breath test.
3. An hourly blood collection via peripheral cannulation, with about 1 tablespoon (3mL) of blood taken every hour until the end of the study period.
4. A one-off collection of faeces samples (the size of a walnut). It is entirely up to the volunteer to decide if they would like to provide faeces samples on the day of the study clinic visit. If they provide a faeces sample, it will be analysed to evaluate the diversity of the gut bacteria.

For female participants, urine and faeces collection should not be carried out during menstruation.

The collected biological specimens will be analysed for various small molecules e.g. short-chain fatty acids, tricyclic cycles, amino acids, etc using both nuclear magnetic resonance spectroscopy and mass spectrometry-based metabolomics approaches.

Adherence: Volunteers will consume the fibres on-site, and any uneaten fibres will be recorded by the researcher.
Intervention code [1] 325853 0
Treatment: Other
Comparator / control treatment
Control: non-inulin-based fibres.
Comparator: Inulin-based fibres with different sizes
Control group
Active

Outcomes
Primary outcome [1] 334436 0
Changes in the exhaled hydrogen breath using portable hydrogen breath test (exhaled hydrogen breath as a proxy to gut transit time).
Timepoint [1] 334436 0
t= 60, 120, 180, 240, 300, 360, 420 and 480 mins, when t = 0 is when the volunteers are provided the fibres
Secondary outcome [1] 420612 0
-changes in short-chain fatty acids in blood samples as measured using mass spectrometry method.
Timepoint [1] 420612 0
t= 60, 120, 180, 240, 300, 360, 420 and 480 mins, when t = 0 is when the volunteers are provided the fibres
Secondary outcome [2] 420910 0
Exploratory outcome: Changes in small molecules in blood and urine samples using untargeted global profiling methods by nuclear magnetic resonance spectroscopy and mass spectrometry.
Untargeted global profiling methods will detect a range of molecules such as amino acids, sugar, tricyclic cycles, etc.
Timepoint [2] 420910 0
t= 60, 120, 180, 240, 300, 360, 420 and 480 mins, when t = 0 is when the volunteers are provided the fibres
Secondary outcome [3] 420911 0
Microbiome composition in the faeces using Amplicon sequencing.
Timepoint [3] 420911 0
one off on the day of the study clinic visit.

Eligibility
Key inclusion criteria
• An adult over the age of 18
• Body mass index is between 20 -35 kg/m2
• A positive hydrogen breath test using a positive control substance (in this case e.g. 10 g of inulin).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Prescribed a course of antibiotics or undergone colonoscopy procedures four weeks before your take part in this study
• Consuming concentrated probiotics e.g. IBS Support Probiotics, Inner Health Plus, or VSL#3 two weeks before taking part in this study.
• Use of enemas for two weeks before taking part in this study.
• Unable to read or understand English, or follow study protocol
• Allergic/intolerant to any of the ingredients provided as part of the standardise meals, and the test food

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed - volunteers have the choice of which fibres they would consume as part of the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Volunteers have the choice of which fibres they would consume as part of the study. Volunteers may choose more than one fibre as long as there is a gap of one week between fibres.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A range of multivariate and univariate statistics will be used to compare t=0 to subsequent time points.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2023
Actual
29/03/2024
Date of last participant enrolment
Anticipated
21/05/2025
Actual
29/03/2024
Date of last data collection
Anticipated
28/05/2025
Actual
29/03/2024
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313621 0
Commercial sector/Industry
Name [1] 313621 0
Mt Lindesay - Future Food System Cooperative Research Centre
Country [1] 313621 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 315414 0
None
Name [1] 315414 0
Address [1] 315414 0
Country [1] 315414 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312794 0
Murdoch University Human Research Ethics Comittee
Ethics committee address [1] 312794 0
90 South Street
Murdoch WA 6150
Ethics committee country [1] 312794 0
Australia
Date submitted for ethics approval [1] 312794 0
03/02/2023
Approval date [1] 312794 0
30/05/2023
Ethics approval number [1] 312794 0

Summary
Brief summary
Inulin is a type of dietary fibres commonly found in plants such as Jerusalem artichoke and garlic. Compared to dietary fibres that are non-inulin based such as apple and watermelon, inulin-based fibres have been shown to improve sugar control and digestive health, aid weight loss and improve lipid profiles. From animal studies, we also known that the size of inulin also affects how quickly it gets to the lower gut and is being broken down into various compounds that can produce a positive health impact. However, little research has been done on humans using actual dietary fibres. This study is designed to investigate how quickly different types of inulin and non-inulin based fibres are being digested. We will also test how these different types of fibres alter the biochemical changes in the body.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125946 0
A/Prof Ruey Leng Loo
Address 125946 0
Australian National Phenome Centre/Centre for Computational and Systems Medicine,
Murdoch University,
5 Robin Warren Drive,
Murdoch WA 6150
Country 125946 0
Australia
Phone 125946 0
+61 893601371
Fax 125946 0
Email 125946 0
rueyleng.loo@murdoch.edu.au
Contact person for public queries
Name 125947 0
A/Prof Ruey Leng Loo
Address 125947 0
Australian National Phenome Centre/Centre for Computational and Systems Medicine,
Murdoch University,
5 Robin Warren Drive,
Murdoch WA 6150
Country 125947 0
Australia
Phone 125947 0
+61 893601371
Fax 125947 0
Email 125947 0
rueyleng.loo@murdoch.edu.au
Contact person for scientific queries
Name 125948 0
A/Prof Ruey Leng Loo
Address 125948 0
Australian National Phenome Centre/Centre for Computational and Systems Medicine,
Murdoch University,
5 Robin Warren Drive,
Murdoch WA 6150
Country 125948 0
Australia
Phone 125948 0
+61 893601371
Fax 125948 0
Email 125948 0
rueyleng.loo@murdoch.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The ethical statement and informed consent do not allow for free data availability.


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.