Skip to content

The effect of increased fibre intake on HbA1c and peripheral immune cells in diabetes

The effect of increased fibre intake on HbA1c and peripheral immune cells in diabetes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001149853
Acronym
None
Enrollment
30
Registered
2021-08-26
Start date
2022-02-17
Completion date
2022-12-19
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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.

Sponsors

Capital and Coast DHB
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026