Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001289404
Ethics application status
Approved
Date submitted
29/08/2016
Date registered
14/09/2016
Date last updated
14/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of high amylose wheat flour on the metabolic health of healthy Australian adults
Scientific title
Determination of the metabolic health effects of breads made from wholemeal and refined high amylose wheat flour in healthy Australian adults
Secondary ID [1] 289941 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic health 299925 0
Condition category
Condition code
Metabolic and Endocrine 299821 299821 0 0
Normal metabolism and endocrine development and function
Diet and Nutrition 299822 299822 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The dietary intervention trial will use a controlled, completely randomised crossover design and comprise seven dietary treatments (glucose reference drinks completed on 3 occasions and four different types of bread). The four bread types include 1 wholemeal flour using conventional wheat, 1 refined flour using conventional wheat, 1 wholemeal flour using high amylose wheat, 1 refined flour using high amylose wheat. The nutrient composition of the breads are based on standard wholemeal and white breads that are commercially available. The trial will run for approximately 8 weeks and will involve 7 clinic visits that are approx. 4 hours duration.

Each participant will consume the 4 different types of bread and the control glucose drink (completed on 3 occasions) with a total of 7 days of testing, approximately 1 week apart. The amount of each bread type and glucose drink will equate to 50 g of carbohydrate. The order in which the 4 breads and 3 glucose drinks are to be consumed will be randomised across the 7 visits.

Prior to each clinic visit, participants will be asked to avoid eating foods high in fibre, avoid heavy exercise and avoid consuming alcohol 24 hours prior. Participants will fast (no food or drinks except water) for 12 hours prior to each visit. Upon arrival at the clinic participants will have their height and weight measured and an initial finger prick blood sample will be taken to ensure blood glucose level is below 5.5mM before a cannula is inserted into the forearm for a baseline blood sample. Participants will then consume the bread or glucose drink and subsequent blood samples will be collected at 15, 30, 45, 60, 90,120, 150, 180 minutes. Cannula insertion for blood sampling will occur at each study visit, amounting to a total of 9 blood draws and an overall total of 55ml (about 3 tablespoons full) per visit. The cannula remains in place for 3 hours and is removed after the last blood sample.

Participants will complete a visual analogue scale to measure satiety at time point 0 and every 30 minutes up to 180 minutes.

Six of 20 participants will be randomly selected to also provide hourly breath samples so that breath hydrogen can be determined using a Gastrolyser. Breath hydrogen will be measured at 30 minute intervals during the blood sampling period. Once the last blood sample is collected at 3 hr, participants will take the portable Gastrolyser with them and continue to measure the breath hydrogen levels at 30 min intervals for a further 9 hr (total 12 hr).
Intervention code [1] 295627 0
Lifestyle
Intervention code [2] 295628 0
Prevention
Comparator / control treatment
glucose reference drink providing 50g of carbohydrate to be repeated on 3 occasions
Control group
Active

Outcomes
Primary outcome [1] 299391 0
Plasma glucose concentration - analysed on a Hitachi autoanalyser
Timepoint [1] 299391 0
time point 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Primary outcome [2] 299487 0
Insulin secretion in plasma using a multiplex assay
Timepoint [2] 299487 0
time point 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Primary outcome [3] 299573 0
Satiety hormone response (GIP, GLP-1, PYY, Ghrelin) in plasma using a multiplex assay
Timepoint [3] 299573 0
time point 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Secondary outcome [1] 327028 0
Appetite sensations (hunger, satiety, mood) using a visual analogue scale
Timepoint [1] 327028 0
time point 0, 30, 60, 90, 120, 150 and 180 minutes
Secondary outcome [2] 327307 0
Breath samples will be analysed for changes in hydrogen content, an indirect measure of intestinal fermentation (n=6)
Timepoint [2] 327307 0
time point 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480, 510, 540, 570, 600, 630, 660, 690, 720 minutes
Secondary outcome [3] 327308 0
Advanced glycation end products using the AGE reader
Timepoint [3] 327308 0
time point 0 and 180 minutes
Secondary outcome [4] 327644 0
Primary Outcome:
Time to reach maximal plasma glucose concentration
Timepoint [4] 327644 0
time point 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Secondary outcome [5] 327645 0
Primary outcome:
Plasma glucose incremental area under the curve
Timepoint [5] 327645 0
time point 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes

Eligibility
Key inclusion criteria
Males and females aged 18-65 years, BMI between 18.5 and less than or equal to 27.5 kg/m2, Normal fasting blood glucose concentration of 3.5 - 5.5 mmol/L
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known presence of diabetes
2. History of smoking in the past 6 months
3. Pregnant or lactating
4. Sufferers of bleeding disorders
5. Known food allergy, hypersensitivity or intolerance to wheat and/or starchy foods
6. Taking medications known to influence glucose tolerance or gastric emptying (oral contraceptives are excepted) such as the following lists which comprise the main classes of drugs prescribed for diabetes mellitus and those that alter gastric emptying respectively:
Diabetes mellitus: Biguanides; Sulphonylureas; Meglitinide derivatives; Alpha-glucosidase inhibitors; Thiazolidinediones (TZDs); Glucagonlike peptide-1 (GLP-1) agonists; Dipeptidyl peptidase IV (DPP-4) inhibitors; Selective sodium- glucose transporter-2 (SGLT-2) inhibitors; Insulins; Amylinomimetics; Bile acid sequestrants; Dopamine agonists
Gastric emptying: Atropine and anticholinergics; Certain antihistamines (diphenhydramine, promethazine); Tricyclic antidepressants; Phenothiazines; Sympathomimetics; Nitrites; anticholinesterases; Sedative hypnotics; Antacids
7. Persons considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol
8. Participation in another research study within 30 days preceding the start of this study
9. Known history or presence of gastrointestinal, renal or hepatic disease of any cause
10. Night shift workers

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)
The allocation schedule will be determined by a staff member not involved in entering participants into the trial. The schedule will remain concealed from those staff members until after study ID assignment.
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 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
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2016
Actual
Date of last participant enrolment
Anticipated
31/10/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 294374 0
Commercial sector/Industry
Name [1] 294374 0
Arista Cereal Technologies Pty Ltd
Country [1] 294374 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
PO Box 10097
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 293218 0
None
Name [1] 293218 0
None
Address [1] 293218 0
None
Country [1] 293218 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295793 0
CSIRO Health and Medical Human Research Ethics Committee
Ethics committee address [1] 295793 0
Ethics committee country [1] 295793 0
Australia
Date submitted for ethics approval [1] 295793 0
Approval date [1] 295793 0
07/02/2014
Ethics approval number [1] 295793 0
13/2013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68278 0
Dr Tony Bird
Address 68278 0
CSIRO Health and Biosecurity
PO Box 10041
Adelaide SA 5000
Country 68278 0
Australia
Phone 68278 0
+61 8 8303 8902
Fax 68278 0
Email 68278 0
[email protected]
Contact person for public queries
Name 68279 0
Bianca Benassi-Evans
Address 68279 0
CSIRO Nutrition and Health Research Clinic
PO Box 10097
Adelaide BC SA 5000
Country 68279 0
Australia
Phone 68279 0
+61 8 8303 8982
Fax 68279 0
Email 68279 0
[email protected]
Contact person for scientific queries
Name 68280 0
Tony Bird
Address 68280 0
CSIRO Health and Biosecurity
PO Box 10041
Adelaide SA 5000
Country 68280 0
Australia
Phone 68280 0
+61 8 8303 8902
Fax 68280 0
Email 68280 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseHigh-amylose wheat lowers the postprandial glycemic response to bread in healthy adults: A randomized controlled crossover trial.2019https://dx.doi.org/10.1093/jn/nxz067
N.B. These documents automatically identified may not have been verified by the study sponsor.