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Trial registered on ANZCTR


Registration number
ACTRN12621001149853
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
26/08/2021
Date last updated
31/08/2023
Date data sharing statement initially provided
26/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of increased fibre intake on HbA1c and peripheral immune cells in diabetes
Scientific title
The effect of increased fibre intake on HbA1c and peripheral immune cells in diabetes
Secondary ID [1] 298412 0
None
Universal Trial Number (UTN)
U1111-1267-4663
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 313119 0
Condition category
Condition code
Metabolic and Endocrine 320262 320262 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an intervention study of a fibre supplement (Metamucil, psyllium husk) 6.8g twice daily (total dose 13.6g) for 12 weeks. This is given as a powder and dissolved in 200ml cold water. Packaging will be returned to determine compliance.
Intervention code [1] 314660 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320303 0
HbA1c from blood sample
Timepoint [1] 320303 0
Baseline, 12 weeks after the start of the intervention
Secondary outcome [1] 371121 0
fasting glucose from blood sample
Timepoint [1] 371121 0
Baseline, 12 weeks after the start of the intervention
Secondary outcome [2] 397701 0
fasting blood lipids from blood sample
Timepoint [2] 397701 0
Baseline, 12 weeks after the start of the intervention
Secondary outcome [3] 397703 0
Baseline, Peripheral blood immune cell functional change - exploratory outcome, from blood sample.
Timepoint [3] 397703 0
Baseline, 12 weeks after the start of the intervention and 14 weeks after the start of the intervention

Eligibility
Key inclusion criteria
Males and females 18 years - 85 years
Pre-diabetes or type 2 diabetes with HbA1c between 45 mmol/mol and 70 mmol/mol inclusive from a test within the last 3 months. At least 75% of participants will have an HbA1c >50mmol/mol.
A low fibre intake of <18g/day for women or 22g/day for men using the Massey University DFiT fibre screening tool.
Willing to maintain stable diet and exercise patterns throughout the study
Stable medication for lipid lowering and hypertension for 3 months prior to study entry
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous bariatric surgery
Pregnancy or breast feeding
Immune altering medications – long-term antibiotics, steroids, immune suppressants
Insulin use
Swallowing difficulties (therefore unable to consume Metamucil)
Unable to consume psyllium soluble fibre for any reason – allergy, physical difficulties

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be by a mixed linear model with random effects for participants and fixed effects for baseline HbA1c.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/09/2021
Actual
17/02/2022
Date of last participant enrolment
Anticipated
30/12/2022
Actual
19/12/2022
Date of last data collection
Anticipated
Actual
12/04/2023
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 21570 0
New Zealand
State/province [1] 21570 0
Wellington

Funding & Sponsors
Funding source category [1] 302959 0
Government body
Name [1] 302959 0
National Science Challenge High Value Nutrition
Country [1] 302959 0
New Zealand
Primary sponsor type
Hospital
Name
Capital and Coast DHB
Address
Clinical Trials Unit
Wellington Hospital
Private Bag 7902
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 302916 0
None
Name [1] 302916 0
None
Address [1] 302916 0
None
Country [1] 302916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303514 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 303514 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 303514 0
New Zealand
Date submitted for ethics approval [1] 303514 0
20/08/2021
Approval date [1] 303514 0
08/10/2021
Ethics approval number [1] 303514 0
21/STH/218

Summary
Brief summary
Increased dietary fibre and the subsequent production of short chain fatty acids (SCFA) by gut microbiota is known to influence immune cell function and metabolic activity. High fibre diets correlate to decreased inflammatory markers in T2DM, and in animal experiments dietary fibre derived SCFA have been found to reduce inflammatory markers and protect against diabetic neuropathies. Furthermore modulation of immune cell metabolism by SCFA can lead to a rebalancing away from pro-inflammatory phenotypes. We hypothesise that in addition to improving clinical indicators such as HbA1c, fibre supplementation will lead to altered peripheral immune cell metabolic and phenotypic parameters.
In this study, we will conduct analyses, to allow for functional immune profiling of trial participants, to provide insights on how enhanced fibre intake in T2DM impacts immunological metabolism and function. To do this we will isolate peripheral blood mononuclear cell (PBMCs) from trial participants before and during a dietary fibre intervention. We will use high dimensional spectral flow cytometry and extracellular flux analysis to profile functional phenotypes and metabolic characteristics of individual immune populations. We will compare these, to potential changes in blood plasma cytokine levels, faecal metabolite profiles and changes in clinical readouts (eg. HbA1c).
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 93926 0
Dr Rosemary Hall
Address 93926 0
Level 5 Grace Neill Block
Wellington Hospital
Private Bag 7902
Wellington 6021
Country 93926 0
New Zealand
Phone 93926 0
+6448062458
Fax 93926 0
Email 93926 0
[email protected]
Contact person for public queries
Name 93927 0
Amber Parry Strong
Address 93927 0
Level 5 Grace Neill Block
Wellington Hospital
Private Bag 7902
Wellington 6021
Country 93927 0
New Zealand
Phone 93927 0
+6448062458
Fax 93927 0
Email 93927 0
[email protected]
Contact person for scientific queries
Name 93928 0
Amber Parry Strong
Address 93928 0
Level 5 Grace Neill Block
Wellington Hospital
Private Bag 7902
Wellington 6021
Country 93928 0
New Zealand
Phone 93928 0
+6448062458
Fax 93928 0
Email 93928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At present this information is confidential due to possible commercial benefits.


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.