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Gastroparesis symptoms and its treatment using low-viscosity soluble dietary fibres

The Short-Term Effects and Tolerability of Low-Viscosity Soluble Fibre on Gastroparesis Patients: A Pilot Clinical Intervention Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001646831
Enrollment
10
Registered
2021-12-01
Start date
2018-07-02
Completion date
2020-02-05
Last updated
2021-12-21

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

Conditions

None listed

Brief summary

The principal aim of this clinical study was to determine the short-term blood-glucose control and tolerability of Partially-hydrolysed guar gum (PHGG) and Gum Arabic in mild-to-moderate symptom gastroparesis patients. There were four interventions in total, the test fibres PHGG and Gum Arabic, the positive control Psyllium Husk and the negative control Water. The study hypothesizes that the 'low-viscosity' test fibres PHGG and Gum Arabic provide blood glucose regulation / control comparable to the positive control, Psyllium Husk, while causing fewer severe symptoms comparable to the negative control, Water.

Interventions

Each participant clinical study involved a total of four interventions (Over the course of four weeks). All interventions were given under supervised administration (Face-to-Face) at the MacArthur Clinical School, Western Sydney University (WSU), Campbelltown, NSW 2560, Australia. Each intervention session included a supervised 3.5 hours monitoring period where measurements were taken. Interventions were delivered to participants by Harsha Suresh (Co-Investigator, PhD Candidate) under the supe

Each participant clinical study involved a total of four interventions (Over the course of four weeks). All interventions were given under supervised administration (Face-to-Face) at the MacArthur Clinical School, Western Sydney University (WSU), Campbelltown, NSW 2560, Australia. Each intervention session included a supervised 3.5 hours monitoring period where measurements were taken. Interventions were delivered to participants by Harsha Suresh (Co-Investigator, PhD Candidate) under the supervision of Dr. Vincent Ho (Co-Investigator, Clinical Gastroeneterologist) and Dr. Jerry Zhou (Principal Investigator, Clinical Scientist). The four interventions were Water (200 mL) as a negative control baseline and dietary fibres supplements (10 g in 200 mL) of Partially-hydrolysed guar gum (PHGG), Gum Arabic and Psyllium Husk. Psyllium Husk was assigned as the positive control. Each intervention was followed by the supplementation of Actilax (10 mL) and a glucose challenge (50 grams in 300 mL). Each intervention (Water, PHGG, Gum Arabic & Psyllium Husk) was delivered only once for each participant. The interventions were spaced 1-week apart from each other. The negative control (Water) intervention was given on Week 1 followed by dietary fibre interventions in Weeks 2, 3 & 4. The dietary fibre interventions (PHGG, Gum Arabic & Psyllium Husk) were given in randomized order (The order of dietary fibre interventions was different for each participant).

Sponsors

Western Sydney University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

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

Inclusion criteria

Participants diagnosed with gastroparesis by their physician through a gastric scintigraphy (Tc-99m radio labelled) study.

Exclusion criteria

Participants requiring enteral feeding (i.e,, feeding tubes) were excluded. Participants with allergies to wheat-based products were excluded (Celiac disease). Participants with co-morbidities related to gastroparesis other than Type-1 or Type-2 diabetes were excluded. Participants who were pregnant were excluded. Participants who could not provide informed self-consent were excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026