Digestive health effects of high amylose wheat in healthy Australian men and wome

Not Applicable

• Conditions: Gut health; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12618001060235
• Lead Sponsor: Arista Cereal Technologies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-26
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

•Healthy adult male or female, aged 18-80 years.
•BMI 18.5-29.9 kg/m2.
•Understand the study requirements, including faecal collections and willing to adhere closely to prescribed food consumption as per the research protocol.
•Willing to maintain body weight for the duration of the study (i.e. no more than 3 kg weight loss/gain).

Exclusion Criteria

EXCLUSION CRITERIA
•Received any medication or undergone surgery that in the opinion of the Principal Investigator or designee could interfere with the study and likely to modulate gut function.
•Self-reported history of alcohol or drug abuse.
•Self-reported participation in a study with any experimental drug within 30 days of commencement of the study.
•Self-reported history of diabetes, gastrointestinal, renal, hepatic disease or intestinal inflammation, including inflammatory bowel disease (Crohn’s disease and ulcerative colitis), coeliac disease, irritable bowel syndrome, chronic constipation or regular bouts of diarrhoea.
•Use of any form of medication/nutraceutical that may interfere with bowel function (such as antibiotics, laxatives, fibre supplements consumed on a regular basis).
•Known or suspected allergy, hypersensitivity or intolerance to consumption of plant-based foods which will be tested in this study.
•Night shift worker
•History of smoking within the 6 months prior to the study
•Self-reported pregnant or currently lactating women
•Extended absences due to travel or other commitments

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Faecal total short-chain fatty acid excretion (mmol/L). [4 weeks post-intervention commencement];Faecal total short-chain fatty acid excretion (mmol/48hr).[4 weeks post-intervention commencement];Faecal wet weight (g/48hr)[4 weeks post-intervention commencement]