None listed
Conditions
Brief summary
The objective of this study is to determine whether ingested acetate which has been chemically attached to starch is released in the gastrointestinal tract of healthy humans. This will be determined by feeding known amounts of a high amylose maize starch to volunteers and measuring acetate levels in faeces, microbial population diversity, bowel health parameters, and blood electrolyte levels. This study will provide information about the effects and acceptability of the acetylated starch in healthy individuals and will provide the basis for clinical studies in patients with diarrhoeal disease.
Interventions
4 x 4 double blind crossover study examining 2 starches (1) control starch at 2 dose rates (a) 20g per day, (b) 40g per day and (2) modified starch at 2 dose rates (a) 20g per day, (b) 40g per day. Beginning with 14 days on low resistant starch diet then 4 x Intervention periods of 14 days 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
CSIRO Preventative Health Flagship
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Outcome results
None listed