Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000898954
Ethics application status
Approved
Date submitted
10/07/2020
Date registered
11/09/2020
Date last updated
11/09/2020
Date data sharing statement initially provided
11/09/2020
Date results information initially provided
11/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Resistant starch content of bread made from high amylose wheat in adults with an ileostomy
Scientific title
Evaluation of the starch digestibility in bread made from high amylose wheat flour in adults with an ileostomy
Secondary ID [1] 301709 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut health 318161 0
Ileostomy 318162 0
Condition category
Condition code
Diet and Nutrition 316180 316180 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 316532 316532 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be divided into two test periods, each of which consist of 4 consecutive collection days (total of 8 d). The treatment sequence was randomised through the use of a Latin square randomization sequence that included 4 unique sequences: ABDC, BCAD, CDBA, and DACB. Testing will be carried out in the home or workplace of participants and there will be a total of four treatments.
The 4 treatment breads, low amylose wheat-refined, LAW-wholemeal, high amylose wheat-refined and HAW-wholemeal (HAW-W), will be made from low amylose wheat or high amylose wheat flour according to a standard bread recipe (Belobrajdic et al, 2019, J Nutr, doi: 10.1093/jn/nxz067). The starch contents of the LAW and HAW breads were 24% and 74% amylose, respectively.
The study will be run for four days (Monday to Thursday) over two consecutive weeks. During the two 4-d treatment periods and for 24 h before each test period, the participants will consume a diet consisting of foods commonly consumed in a Western diet (e.g. toast with jam, sandwich, yogurt, bollognase, meat and vegetable casserole), which contained low levels of starch. On the first day of each 4-d treatment period, participants will consume their assigned baseline foods only. For the subsequent three days, participants will be randomly assigned to consuming 65 g of 2 different test breads at breakfast on 2 different days or continuing with the baseline diet (no bread). Study participants will be provided with all the foods consumed during these two 4-d periods of dietary restriction. The test breads will be eaten by the participants in addition to the other foods consumed as part of the low-starch diet and a food diary was completed with any deviations recorded.
Each day during the testing period the participants will be asked to collect ileostomy digesta from the ileostomy bag every 2 hours from 7am to 11pm and then again at 7am on the following day with the contents placed in portable freezers (20 °C). The ileostomy digesta samples will be obtained from the participant’s home by research staff and analysed in the laboratory for starch content. The stoma digesta samples from each volunteer collected during each 24 h period (7am until 7am the following day) were defrosted, pooled, homogenized, and subsampled for analysis.
Throughout the study food checklists will be completed by study participants daily for assessment of compliance.
Intervention code [1] 318012 0
Lifestyle
Comparator / control treatment
The control food will be LAW-refined bread (24% amylose) made with conventional flour.
Control group
Active

Outcomes
Primary outcome [1] 324361 0
Ileal starch digestibility (%) will be assessed by laboratory analysis of ileal digesta
Timepoint [1] 324361 0
48 hrs post commencement of consumption of each test bread (primary timepoint).
24 hr intervals (all fecal samples collected from 7am to 7am on the following day will be pooled prior to analysis)
Secondary outcome [1] 384437 0
ileal moisture content (%) will be assessed by laboratory analysis of ileal digesta
Timepoint [1] 384437 0
48 hrs post commencement of consumption of each test bread (primary timepoint).
24 hr intervals (all fecal samples collected from 7am to 7am on the following day will be pooled prior to analysis)

Eligibility
Key inclusion criteria
• Participants must have had minimal terminal ileum removed and have a conventional and well-functioning permanent ileostomy.
• Age 20-80 years.
• Willing to comply with alcohol and study diet restrictions.
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of alcohol or drug abuse.
• Participation in a study within 30 days of commencement of the study.
• Presence of gastrointestinal, renal, hepatic disease or intestinal inflammation.
• Use of any medication that in the opinion of the investigator could interfere with the study or medications (eg antibiotics, codeine) likely to modulate small intestinal function.
• Definite or suspected personal history or family history of adverse events or intolerance of starchy or other foods, which may be tested in this study.
• Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
• Unwilling or unable to collect ileal effluent as required.
• Persons taking any supplements containing carbohydrates (in particular resistant starch such as Hi-maize) which could interfere with study parameters.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/08/2014
Date of last participant enrolment
Anticipated
Actual
11/08/2014
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
8
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 306144 0
Government body
Name [1] 306144 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Country [1] 306144 0
Australia
Primary sponsor type
Government body
Name
CSIRO Health and Biosecurity
Address
Gate 13 Kintore Ave
Adelaide 5000
South Australia
Country
Australia
Secondary sponsor category [1] 306614 0
Commercial sector/Industry
Name [1] 306614 0
Arista Cereal Technologies
Address [1] 306614 0
56 Araba Street
ARANDA ACT 2614
Country [1] 306614 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306364 0
CSIRO Health and Medical Human Research Ethics Committee (CHM HREC)
Ethics committee address [1] 306364 0
Ecosciences Presinct, Dutton Park, QLD 4102
GPO Box 2583
Brisbane, QLD, 4001
Ethics committee country [1] 306364 0
Australia
Date submitted for ethics approval [1] 306364 0
Approval date [1] 306364 0
02/05/2014
Ethics approval number [1] 306364 0

Summary
Brief summary
Foods containing starches that undergo less small intestinal digestion have important implications for human health. By escaping digestion in the upper gut, starch that reaches the large bowel (resistant starch, RS) becomes a substrate for microbial fermentation and leads to higher production of short chain fatty acids (SCFA). These acids are not only integral to bowel health and protection against DNA damage, but also influence metabolism of peripheral tissues, including skeletal muscle, adipose tissue depots and liver, and contribute to the regulation and strengthening of immune system function and responses to infection. Additionally, slowing the rate and extent of amylolysis in the small bowel lowers the glycaemic response to food and improves blood glucose control, which can contribute to the prevention and management of type-2 diabetes.
Western diets typically contain little RS because staple foods, such as cereals, are highly processed and contain starches that are readily digested in the upper gut. Consequently, RS intakes are commonly below half the suggested level of 20 g of RS per day for providing a range of health benefits. To help address this, we developed a wheat variety that contains high levels of amylose, a type of starch that has low digestibility compared to conventional wheat varieties. Although bread made from this wheat variety has a lower glycemic impact compared to conventional bread, its RS content has not been established.
The purpose of this study is to establish the RS content of refined and wholemeal breads made from a novel high amylose wheat (HAW). To do this, we directly quantified the physiological RS content of breads made from a conventional (low amylose) wheat and the novel HAW in healthy ileostomates. It is hypothesised that the new HAW flour contains substantially more resistant starch than the control conventional wheat flour.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103618 0
Dr Tony Bird
Address 103618 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Gate 13 Kintore Ave
Adelaide, SA, 5000
Country 103618 0
Australia
Phone 103618 0
+61883038815
Fax 103618 0
Email 103618 0
[email protected]
Contact person for public queries
Name 103619 0
Dr Damien Belobrajdic
Address 103619 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Gate 13 Kintore Ave
Adelaide, SA, 5000
Country 103619 0
Australia
Phone 103619 0
+61883038815
Fax 103619 0
Email 103619 0
[email protected]
Contact person for scientific queries
Name 103620 0
Dr Damien Belobrajdic
Address 103620 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Gate 13 Kintore Ave
Adelaide, SA, 5000
Country 103620 0
Australia
Phone 103620 0
+61883038815
Fax 103620 0
Email 103620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Data will be available from the 01/08/2020 with no end date determined.
Available to whom?
Only on a case-by-case basis to researchers who provide a methodologically sound proposal. Data availability will be the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal,
How or where can data be obtained?
Data will be provided by Email from the Contact person for inquires; [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of an ileorectostomised rat model for resistant starch determination.2021https://dx.doi.org/10.3390/nu13010091
N.B. These documents automatically identified may not have been verified by the study sponsor.