None listed
Conditions
Brief summary
The objective of this study is to determine whether bacteria in the colon of humans can release butyrate bound to starch. This will be investigated by feeding a modified test starch to volunteers and measuring butyrate levels in faeces, the effects on the bacteria and other bowel health indicators.
Interventions
4 x 4 double blind crossover study. examining 2 starches (1) control starch (2) modified starch, both at 2 dose rates (1) 20g per day (2) 40g per day. 4 x Intervention periods of 14 days each with a 7 day 'wash out' at starch crossover.
Both starches to be ingested orally by way of combination (starch plus long life milk)
Sponsors
Commonwealth Scientific and Industrial Research Organisation Preventative Health Flagship
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
No
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 If the volunteer becomes pregnant during the trial they will be withdrawn..7.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.
Outcome results
None listed