Modified Starch and Colon Health Study 2006

Phase 1

Completed

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

• Registration Number: ACTRN12606000398505
• Lead Sponsor: Commonwealth Scientific and Industrial Research Organisation Preventative Health Flagship

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

1. Generally in good health 2. Be willing to consume a diet with controlled levels of fibre and carbohydrate during 11 weeks of the study period 3. Willing to comply with faecal sample collection requirements. 4. Available for the duration of the study (15 weeks from February 2006). 5. Have low (<15mmol/L) faecal butyrate concentrations.

Exclusion Criteria

1. Definite or suspected personal or family history of adverse events or hypersensitivity to wheat (eg celiac disease, wheat allergy)2. Use of 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 If the volunteer becomes pregnant during the trial they will be withdrawn..7.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 release of SCFA's (short chain fatty acids) in the colon by way of measuring faecal SCFA's[At the beginning and end of each 14 day test period]

Secondary Outcome Measures

Name	Time	Method
Examine the corresponding changes to colonic microflora populations.[At the beginning and end of each 14 day test period.]