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Trial registered on ANZCTR


Registration number
ACTRN12617001454369
Ethics application status
Approved
Date submitted
9/10/2017
Date registered
13/10/2017
Date last updated
30/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Soluble fibre metabolites in healthy adults
Scientific title
A randomised crossover trial investigating the plasma short chain fatty acid (SCFA) yield of four different soluble fibre supplements in healthy adult males and females.
Secondary ID [1] 293078 0
None
Universal Trial Number (UTN)
U1111-1203-3092
Trial acronym
OLI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 305010 0
Condition category
Condition code
Inflammatory and Immune System 304331 304331 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blinded, randomised, 4-way crossover trial. Participants are required to attend 4 clinic visits. At each clinic visit participants will be randomly allocated to consume one of 4 treatments (4 different soluble fibre formulations, containing 12g of different types of oligosaccharides in various combinations ), plus 2 slices of white bread and 250ml water (room temperature). Study meals will be consumed in random order, with a minimum one-week washout period between clinic visits.

In the 2 days prior to the scheduled appointments, participants will consume a fibre-controlled background diet. This will include consumption of no more than 3 serves of fruits and vegetables combined per day, and avoidance of other high soluble fibre content foods including oats, legumes (kidney, navy, lima, baked beans), wholegrain bread and cereal products. Participants will be provided with a standardised non-fermentable evening meal (lasagna), which they will be asked to consume the night before each of their scheduled appointments. They will also be asked to fast for 12-hours prior to the clinic visit.
Intervention code [1] 299322 0
Treatment: Other
Comparator / control treatment
Control treatment: 12g soluble fibre (inulin), consumed with 2 slices of white bread + 250ml water
Comparator treatments: 3 different soluble fibre formulations, containing 12g of different types of oligosaccharides in various combinations, consumed with 2 slices of white bread + 250ml water
Control group
Active

Outcomes
Primary outcome [1] 303595 0
Incremental area under the curve (iAUC) for plasma short chain fatty acids (SCFA) (total of acetate, butyrate and propionate)
Timepoint [1] 303595 0
4ml of blood will be collected at 0, 3, 5, 7 and 10 hours after the consumption of the study meals to measure plasma short-chain fatty acid levels.
Secondary outcome [1] 339533 0
Gastrointestinal symptoms as assessed by the Gastrointestinal Symptom Rating Scale (GSRS)(modified)
Timepoint [1] 339533 0
Gastrointestinal symptoms will be assessed using the modified GSRS at 0,3, 5, 7 and 10 hours after consumption of the study meals.

Eligibility
Key inclusion criteria
Males and Females
Aged 18+ years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Body Mass Index (BMI)>= 30 kg/m2; nutritional, fibre or probiotic supplement use within the previous 4 weeks; current smokers; pregnancy or breastfeeding; chronic or excessive alcohol consumption; unexplained weight loss (>5% body weight) in the past 6 months; diagnosis of chronic disease, including gastrointestinal, metabolic, liver, cardiovascular and respiratory diseases; current use of anti-inflammatory medications (e.g. corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDS); terminal illness; participation in a research study within previous 4 weeks.

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)
After eligibility is confirmed through a screening visit, participants will be given a unique study number and randomisation number which will determine the order in which they consume the four study meals.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be determined by an independent statistician using computer generated codes.
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
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Bio-availability
Statistical methods / analysis
The incremental area under the curve (iAUC) for plasma SCFA (total, acetate, propionate, butyrate) will be determined using the trapezoidal rule and peak plasma SCFA concentrations will be identified. Differences between meals will be compared using ANOVA or Kruskal-Wallis testing with posthoc analysis, as appropriate. Differences between peak SCFA and baseline will be compared using paired t-test or Wilcoxon rank sum test. In addition, two-way repeated measures ANOVA will be used to test the effect of meal and time on plasma SCFA concentrations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2017
Actual
16/11/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
18/01/2018
Date of last data collection
Anticipated
29/01/2018
Actual
12/02/2018
Sample size
Target
12
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9173 0
Hunter Medical Research Institute - New Lambton Heights
Recruitment postcode(s) [1] 17678 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 297700 0
Commercial sector/Industry
Name [1] 297700 0
Australian Health and Nutrition Association Limited trading as Sanitarium Health & Wellbeing Company
Country [1] 297700 0
Australia
Primary sponsor type
Individual
Name
Professor Lisa Wood
Address
School of Biomedical Science and Pharmacy
University of Newcastle
and
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit
NEW LAMBTON HEIGHTS NSW 2305
Country
Australia
Secondary sponsor category [1] 296731 0
None
Name [1] 296731 0
Address [1] 296731 0
Country [1] 296731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298771 0
Hunter New England Health Research Ethics Committee
Ethics committee address [1] 298771 0
Ethics committee country [1] 298771 0
Australia
Date submitted for ethics approval [1] 298771 0
29/09/2017
Approval date [1] 298771 0
10/11/2017
Ethics approval number [1] 298771 0
17/10/18/4.03

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

Contacts
Principal investigator
Name 78182 0
Prof Lisa Wood
Address 78182 0
School of Biomedical Science and Pharmacy
University of Newcastle
and
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit
NEW LAMBTON HEIGHTS NSW 2305
Country 78182 0
Australia
Phone 78182 0
+61 2 4042 0147
Fax 78182 0
+61 2 4042 0046
Email 78182 0
lisa.wood@newcastle.edu.au
Contact person for public queries
Name 78183 0
Netsi Negewo
Address 78183 0
Priority Research Centre for Healthy Lungs
University of Newcastle
and
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit
NEW LAMBTON HEIGHTS NSW 2305
Country 78183 0
Australia
Phone 78183 0
+61 2 4042 0762
Fax 78183 0
+61 2 4042 0046
Email 78183 0
netsanet.negewo@newcastle.edu.au
Contact person for scientific queries
Name 78184 0
Lisa Wood
Address 78184 0
School of Biomedical Science and Pharmacy
University of Newcastle
and
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit
NEW LAMBTON HEIGHTS NSW 2305
Country 78184 0
Australia
Phone 78184 0
+61 2 4042 0147
Fax 78184 0
+61 2 4042 0046
Email 78184 0
lisa.wood@newcastle.edu.au

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

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

Documents added automatically
No additional documents have been identified.