Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000771459
Ethics application status
Approved
Date submitted
24/05/2016
Date registered
14/06/2016
Date last updated
14/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a preload on postprandial glycaemic response and satiety.
Scientific title
The effect of consuming a carbohydrate preload 30 minutes before a starchy carbohydrate meal on postprandial glycaemic response and satiety in Asian adults.
Secondary ID [1] 289292 0
None
Universal Trial Number (UTN)
U1111-1183-1762
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysglycaemia 298878 0
Condition category
Condition code
Diet and Nutrition 298950 298950 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 298951 298951 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised crossover study involving five visits on five days. On three days, participants will receive breakfast at 8am consisting of a different preload on each day (water, kiwifruit, portion of rice-based meal) followed half an hour later by a rice-based meal. Blood will be sampled via cannula at intervals over two-and-a-half-hours following consumption of the preload. On the other two days, participants will receive a standard breakfast at 8am after which participants will be permitted to leave the facility and asked to return for lunch at 12pm. At lunchtime, the same protocol as described previously (one of two preloads, water and kiwifruit followed by a rice-based meal) will be used. On each test day, the amount of carbohydrate in the preload plus rice meal will be standardized. Subjective appetite ratings will be taken via questionnaire.

The preloads will comprise 2 kiwifruit (24g available carbohydrate; 400kJ); apple segments (24g available carbohydrate; 380kJ); sugar (24g; 400kJ); or water.
The meal following the preloads will comprise cooked white rice (250g containing 50g avail CHO; 840kJ) garnished with leafy green vegetables in soy sauce.
On the days of lunch testing, a standard breakfast will be served comprising noodles (200g containing 40g avail CHO; 600kJ) in beef stock.
The washout will be one week between treatments.
All meals will be eaten under supervision to ensure the preloads and meals are fully consumed. The preload will be eaten within 10 minutes of starting. The test meals will be consumed within 15 minutes of starting.
Intervention code [1] 294842 0
Lifestyle
Intervention code [2] 294876 0
Prevention
Intervention code [3] 294877 0
Treatment: Other
Comparator / control treatment
A water preload will be used as the comparator/control; participants will consume a larger rice meal in one sitting after the water preload, this is to keep carbohydrate amount equal across all test meals.
Control group
Active

Outcomes
Primary outcome [1] 298423 0
Blood glucose response
Timepoint [1] 298423 0
Blood glucose concentrations will be measured at baseline (before eating) and at 15, 30, 45, 60, 75, 90, 120, and 150 minutes thereafter
Primary outcome [2] 298424 0
Satiety will be assessed using a visual analogue scale (reference Flint et al. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes 2000;24:38-48).
Timepoint [2] 298424 0
Satiety will be measured via a validated questionnaire at baseline (before eating) and at 15, 30, 45, 60, 75, 90, 120, and 150 minute thereafter
Primary outcome [3] 298425 0
Circulating blood vitamin C concentration
Timepoint [3] 298425 0
The vitamin C concentration will be measured at baseline (before eating) and at 15, 30, 45, 60, 75, 90, 120, and 150 minutes thereafter
Secondary outcome [1] 324090 0
Blood insulin concentration
Timepoint [1] 324090 0
Blood insulin will be measured at baseline (before eating) and at 15, 30, 60, 90, 120, and 150 minutes thereafter
Secondary outcome [2] 324091 0
Ghrelin concentration using a Milliplex assay
Timepoint [2] 324091 0
We will measure ghrelin concentration in blood samples at baseline (before eating) and at 15, 30, 60, 90, 120, and 150 minutes thereafter
Secondary outcome [3] 324226 0
Glucagon-like peptide-1 (GLP-1) concentration using a Milliplex assay
Timepoint [3] 324226 0
We will measure GLP-1 concentration in blood samples at baseline (before eating) and at 15, 30, 60, 90, 120, and 150 minutes thereafter
Secondary outcome [4] 324673 0
Interleukin-6 (IL-6) concentration using a Milliplex assay
Timepoint [4] 324673 0
We will measure Interleukin-6 (IL-6) concentration in blood samples at baseline (before eating) and at 15, 30, 60, 90, 120, and 150 minutes thereafter

Eligibility
Key inclusion criteria
Healthy adults of Chinese ethnicity
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to speak English; self-reported disease of the digestive system (coeliac, Crohn’s); having had gastrointestinal surgical procedures; an allergy to kiwifruit; and pregnancy.

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 person who will determine whether a person is eligible for inclusion in the trial will be unaware, when this decision is made, to which order the person will be allocated. Allocation concealment will be achieved with the use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A biostatistician will randomise to order of preload using a computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/06/2016
Actual
Date of last participant enrolment
Anticipated
25/07/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 7898 0
New Zealand
State/province [1] 7898 0
Otago

Funding & Sponsors
Funding source category [1] 293668 0
Government body
Name [1] 293668 0
High Value Nutrition
Country [1] 293668 0
New Zealand
Funding source category [2] 293669 0
Commercial sector/Industry
Name [2] 293669 0
Zespri International
Country [2] 293669 0
New Zealand
Funding source category [3] 293670 0
University
Name [3] 293670 0
University of Otago
Country [3] 293670 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 292503 0
Government body
Name [1] 292503 0
Plant and Food Research Limited
Address [1] 292503 0
Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North 4474
Country [1] 292503 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295108 0
University of Otago Human Ethics Committee
Ethics committee address [1] 295108 0
University of Otago
PO Box 56
Dunedin
9054
Ethics committee country [1] 295108 0
New Zealand
Date submitted for ethics approval [1] 295108 0
09/05/2016
Approval date [1] 295108 0
09/06/2016
Ethics approval number [1] 295108 0
H16/066

Summary
Brief summary
It is important to control the glycaemic and hormonal response to food both for people with normal and impaired glucose tolerance. The purpose of the proposed project is to investigate whether glycaemic and hormonal responses to carbohydrate-containing food can be manipulated by providing meals in two stages (a preload given half an hour before the main meal) compared with meals containing the same amount of carbohydrate given in a single sitting. Our hypothesis is that a beneficial effect of lowering the glycaemic response without adversely affecting the insulin or satiety hormone responses will be observed when a preload containing carbohydrate is given before either breakfast or lunch.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66154 0
Dr Bernard Venn
Address 66154 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin
9054
Country 66154 0
New Zealand
Phone 66154 0
+6434795068
Fax 66154 0
Email 66154 0
[email protected]
Contact person for public queries
Name 66155 0
John Monro
Address 66155 0
Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North 4474
Country 66155 0
New Zealand
Phone 66155 0
+6463556137
Fax 66155 0
Email 66155 0
[email protected]
Contact person for scientific queries
Name 66156 0
John Monro
Address 66156 0
Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North 4474
Country 66156 0
New Zealand
Phone 66156 0
+6463556137
Fax 66156 0
Email 66156 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
EmbasePostprandial glycaemic, hormonal and satiety responses to rice and kiwifruit preloads in Chinese adults: A randomised controlled crossover trial.2018https://dx.doi.org/10.3390/nu10081110
N.B. These documents automatically identified may not have been verified by the study sponsor.