The Effect of Acetylated Starch on Colon Health 2009

Phase 1

Completed

• Conditions: Colon health in healthy subjects; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12610000010099
• Lead Sponsor: CSIRO Preventative Health Flagship

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Male or Female 2. Generally in good health 3. Be willing to consume a diet with controlled levels of fibre and carbohydrate during 15 weeks of the study period 4. Willing to comply with blood and faecal sample collection requirements 5. Available for the duration of the study 6. Have low-average faecal acetate levels

Exclusion Criteria

1. Definite or suspected personal family history of adverse events or hypersensitivity to wheat (eg coeliac disease, wheat allergy). 2. Use any form of drug therapy or medication or supplements on a regular basis that may interfere with bowel function (eg laxatives, antibiotics, anti-diarrhoeals or probiotics). 3. Consuming any prescribed or over-the-counter medication that in the opinion of the investigator could interfere with the study (eg Codeine, Panadeine, Nucolox, Metamucil, Sennocot). 4. Participation in a bowel health study or in any study of an experimental drug within 30 days of commencement of this study. 5. History or presence of gastrointestinal, renal or hepatic disease of any cause. 6. Reported lactating, pregnant or wish to become pregnant during the study. If the volunteer becomes pregnant during the study they will be withdrawn. 7. Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To quantify the release of short chain fatty acids (SCFAs) in the colon. SCFA concentrations in faecal samples will be analysed using stndard distillation procedures and gas chromatography.[At the beginning and end of each 14 day test period];To examine changes to electrolyte levels. Venous blood samples will be collected into gel tubes to test for changes in the levels of electrolytes using biochemical analysis.[At the beginning and end of each 14 day test period]

Secondary Outcome Measures

Name	Time	Method
To examine changes in colonic microflora populations and bowel function in faecal samples. Faecal sample measures include faecal bulk, pH, moisture and microflora profiles.[At the beginning and end of each 14 day test period]