None listed
Conditions
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 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
Study design
Eligibility
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.