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Investigating the effectiveness of a novel starch in participants suffering a functional bowel disorder

A placebo controlled double-blind cross over study in participants suffering a functional bowel disorder comparing the effects of supplementation with butyrylated high amylose starch (HAMSB) with placebo starch (low amylose maize starch, LAMS) on overall gastrointestinal symptoms.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000384651
Enrollment
35
Registered
2014-04-09
Start date
2015-11-24
Completion date
2016-10-10
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

To assess the effectiveness of butyrylated high amylose maize starch (HAMSB) in reducing gastrointestinal symptoms in volunteers suffering a functional bowel disorder. Aim 1: The primary aim is to determine if ingestion of HAMSB reduces symptoms in subjects that suffer a functional bowel disorder HAMSB. Aim 2: The secondary aim is to determine the effect of HAMSB on blood inflammatory markers and faecal microbiota in subjects suffering a functional bowel disorder.

Interventions

Treatment interventions were dietary butyrylated high amylose maize starch (HAMSB) or low amylose maize starch (LAMS) which were consumed daily for 14 days, The starch supplement (HAMSB or placebo starch) consisted of two pre-packed 20 g sachets daily, one consumed in the morning and one in the evening. The supplements were consumed by mixing the starches into 250 mL reduced fat flavoured UHT milk, orange juice, water or foods by the participants. The first intervention was followed by a washout

Treatment interventions were dietary butyrylated high amylose maize starch (HAMSB) or low amylose maize starch (LAMS) which were consumed daily for 14 days, The starch supplement (HAMSB or placebo starch) consisted of two pre-packed 20 g sachets daily, one consumed in the morning and one in the evening. The supplements were consumed by mixing the starches into 250 mL reduced fat flavoured UHT milk, orange juice, water or foods by the participants. The first intervention was followed by a washout period of 4 weeks during which the participants did not consume any intervention and ate their normal diets. The washout was followed by 2 weeks consumption of the alternative intervention. All unused sachets were collected to monitor compliance, and SCFA levels will be measured in the stools of subjects to further verify compliance to the test starches.

Sponsors

CSIRO Health and Biosecurity
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Medically diagnosed with a functional bowel disorder

Exclusion criteria

1. Constipation is only symptom 2. Intolerant to high fibre products 3. Celiac disease 4. Previous abdominal surgery 5. Diabetes 6. Use of antibiotics for 2 months prior to the commencement of the trial 7. Using anti-diarrhoeal drugs 8. Pregnant or breast feeding, or intending to become pregnant during the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026