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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gut health

Ileostomy

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Oral and Gastrointestinal

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]

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]

Ileal starch digestibility (%) will be assessed by laboratory analysis of ileal digesta

Timepoint [1]

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]

ileal moisture content (%) will be assessed by laboratory analysis of ileal digesta

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Commonwealth Scientific and Industrial Research Organisation (CSIRO)

Address [1]

CSIRO Food Futures Flagship
Building 101, Clunies Ross Street
Black Mountain ACT 2601

Country [1]

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]

Commercial sector/Industry

Name [1]

Arista Cereal Technologies

Address [1]

56 Araba Street
ARANDA ACT 2614

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CSIRO Health and Medical Human Research Ethics Committee (CHM HREC)

Ethics committee address [1]

Ecosciences Presinct, Dutton Park, QLD 4102
GPO Box 2583
Brisbane, QLD, 4001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/05/2014

Ethics approval number [1]

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

Dr Tony Bird

Address

Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Gate 13 Kintore Ave
Adelaide, SA, 5000

Country

Australia

Phone

+61883038815

Fax

[email protected]

Contact person for public queries

Name

Damien Belobrajdic

Address

Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Gate 13 Kintore Ave
Adelaide, SA, 5000

Country

Australia

Phone

+61883038815

Fax

[email protected]

Contact person for scientific queries

Name

Damien Belobrajdic

Address

Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Gate 13 Kintore Ave
Adelaide, SA, 5000

Country

Australia

Phone

+61883038815

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Evaluation of an ileorectostomised rat model for resistant starch determination.	2021	https://dx.doi.org/10.3390/nu13010091

N.B. These documents automatically identified may not have been verified by the study sponsor.

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