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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615001263583 |
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Date of registration:
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19/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Can Phytochemicals Alter Intestinal Carbohydrate Digestion in Ileostomates
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Scientific title:
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Phytochemicals and carbohydrate digestion in ileostomates as measured by ileal carbohydrate excretion |
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Date of first enrolment:
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13/11/2015 |
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Target sample size:
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6 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12615001263583.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Bianca Benassi-Evans
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Address:
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CSIRO Food and Nutrition
Gate 13 Kintore Ave
Adelaide SA 5000
Australia |
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Telephone:
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+61 8 83038982 |
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Email:
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bianca.benassi-evans@csiro.au |
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Affiliation:
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Name:
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Dr Tony Bird
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Address:
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CSIRO Food and Nutrition
Gate 13 Kintore Ave
Adelaide SA 5000
Australia |
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Telephone:
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+61 8 83038902 |
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Email:
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tony.bird@csiro.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: minimal terminal ileum removed
Exclusion criteria: History of drug or alcohol abuse
Participation in a study within 30 days of commencement of the present study.
Use of any medication or supplement that may, in the opinion of the Principal Investigator, interfere with the study or small intestinal function.
Definite or suspected personal or family history of intolerance or adverse events following consumption of foods which may be tested in this study.
Person considered, in the opinion of the Principle Investigator, to be unwilling, unlikely or unable to comprehend or comply with the study protocol.
Unwilling or unable to collect ileal effluent as required.
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Diet and Nutrition - Obesity
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obesity;
obesity
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Oral and Gastrointestinal - Normal oral and gastrointestinal development and function
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Intervention(s)
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Participants will adhere to a low starch and sucrose dietary pattern for 4 days (Monday-Thursday) as set by the research dietitian; with the exception of a daily high starch/high sucrose breakfast test meal. Monday is a planned run in day and Wednesday a washout day. On Tuesday and Thursday participants will be randomised to consume one of two test drinks with the breakfast meal. Drinks are identical with the exception of one containing a phytonutrient rich sugar cane molasses extract, made up in water to a volume of 355mL. Dietary compliance is assessed by dietary records. Ileal efflux is collected at regular intervals (2 hourly; 07:00-23:00) for the duration of the study to measure carbohydrate excretion.
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Primary Outcome(s)
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ileal carbohydrate excretion - AOAC official method 996.11; Prosky gravimetric technique[0-24 hrs post test meal/drink]
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Secondary Outcome(s)
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none[none]
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Source(s) of Monetary Support
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The Product Makers (TPM)
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Ethics review
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Status: Approved
Approval date:
Contact:
CSIRO Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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