Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000708257
Ethics application status
Approved
Date submitted
27/04/2018
Date registered
1/05/2018
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Soluble fibre metabolites in healthy adults- Part B
Scientific title
A randomised crossover trial investigating the plasma short chain fatty acid (SCFA) yield of two different soluble fibre supplements in healthy adult males and females
Secondary ID [1] 294358 0
None
Universal Trial Number (UTN)
U1111-1211-0368
Trial acronym
OLI- Part B
Linked study record
This study follows on from previous trial: ACTRN12617001454369

Health condition
Health condition(s) or problem(s) studied:
Inflammation 307079 0
Condition category
Condition code
Inflammatory and Immune System 306189 306189 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blinded, randomised, 2-way crossover trial. Participants are required to attend 2 clinic visits. At each clinic visit participants will be randomly allocated to consume one of 2 treatments (2 different soluble fibre formulations, containing 12g of different types of oligosaccharides), 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. Adherence to the intervention will be monitored by direct observation by study personnel.

In the two days prior to the scheduled appointments, participants will consume 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] 300659 0
Treatment: Other
Comparator / control treatment
Control treatment: 12g oligosaccharide blend (dairy origin), consumed with 2 slices of white bread +250ml water.

Comparator treatment: 12g oligosaccharide blend (plant origin), consumed with 2 slices of white bread + 250ml water.
Control group
Active

Outcomes
Primary outcome [1] 305197 0
Incremental area under the curve (iAUC) for plasma short chain fatty acids (SCFA) (total of acetate, butyrate and propionate)
Timepoint [1] 305197 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] 344479 0
Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS) (modified).
Timepoint [1] 344479 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)>= 3okg/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 two 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
Peak plasma SCFA concentrations will be identified and the incremental area under the curve (iAUC) for plasma SCFA (total, acetate, propionate, butyrate) will be determined using the trapezoidal rule. Differences between peak SCFA and baseline will be compared using paired t-test or Wilcoxon rank sum test. Differences between meals will be compared using ANOVA or Kruskal-Wallis testing with posthoc analysis, as appropriate. 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
14/05/2018
Actual
10/05/2018
Date of last participant enrolment
Anticipated
15/06/2018
Actual
18/06/2018
Date of last data collection
Anticipated
29/06/2018
Actual
25/06/2018
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10402 0
Hunter Medical Research Institute - New Lambton Heights
Recruitment postcode(s) [1] 22087 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 299000 0
Commercial sector/Industry
Name [1] 299000 0
Australian Health and Nutrition Association Limited trading as Sanitarium Health & Wellbeing Company
Country [1] 299000 0
Australia
Primary sponsor type
Individual
Name
Professor Lisa Wood
Address
School of Biomedical Sciences 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] 298224 0
None
Name [1] 298224 0
Address [1] 298224 0
Country [1] 298224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299933 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 299933 0
Lookout Road
New Lambton NSW 2305
Postal address:
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 299933 0
Australia
Date submitted for ethics approval [1] 299933 0
20/03/2018
Approval date [1] 299933 0
01/05/2018
Ethics approval number [1] 299933 0

Summary
Brief summary
Soluble fibre is a source of plasma short chain fatty acids (SCFA), which are known to have antiinflammatory properties. This study will investigate the plasma short chain fatty acid (SCFA) yield over 10 hours following consumption of two different oligosaccharide blends in healthy adult males and females. This information will be used in the design of future clinical intervention trials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82018 0
Prof Lisa Wood
Address 82018 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 82018 0
Australia
Phone 82018 0
+61 2 4042 0147
Fax 82018 0
+61 2 4042 0046
Email 82018 0
lisa.wood@newcastle.edu.au
Contact person for public queries
Name 82019 0
Dr Netsi Negewo
Address 82019 0
School of Medicine and Public Health/School of Biomedical Science and Pharmacy
University of Newcastle
and
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit
NEW LAMBTON HEIGHTS NSW 2305
Country 82019 0
Australia
Phone 82019 0
+61 2 4042 0762
Fax 82019 0
+61 2 4042 0046
Email 82019 0
netsanet.negewo@newcastle.edu.au
Contact person for scientific queries
Name 82020 0
Prof Lisa Wood
Address 82020 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 82020 0
Australia
Phone 82020 0
+61 2 4042 0147
Fax 82020 0
+61 2 4042 0046
Email 82020 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

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