Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000687897
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
26/06/2012
Date last updated
27/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of consuming a meal consisting of potato or sweetpotato on the feelings of hunger/ fullness and health related blood measurements
Scientific title
The effect of consuming potato and sweetpotato by healthy adults on post-prandial satiety, glycaemia and oxidative stress biomarkers related to chronic disease prevention.
Secondary ID [1] 280382 0
Nil
Universal Trial Number (UTN)
U1111- 1130- 0473
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 286413 0
Diabetes 286414 0
Condition category
Condition code
Diet and Nutrition 286668 286668 0 0
Obesity
Metabolic and Endocrine 286669 286669 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prevention
Description of Test meal:
The meal consists of 400g of potato/ sweetpotato, 30g of low fat salad dressing, 5g of spring onion as garnish and 0.5 g of salt

Duration of administration: Participants will fast overnight only consuming water (after consuming a standard dinner provided to them the night before the test day). The entire meal will be consumed within 10 minutes.

Time of administration: In the morning for breakfast (8 am - 12 pm)

Frequency of administration: Once every alternate week for 10 weeks

Number of interventions: 5

Intervention 1: Cooked sweetpotato (hot)
Intervention 2: Cooked sweetpotato (cooled for 24 hours at 4 degrees; served cold)
Intervention 3: Cooked potato (hot)
Intervention 4: Cooked potato (cooled for 24 hours at 4 degrees celcius )
Intervention 5: White bread as control

Duration of intervention and wash out period between intervention: Each participant will visit 5 times (once every alternate week for a duration of 10 weeks with a wash out period of 2 weeks between interventions
Intervention code [1] 284745 0
Prevention
Comparator / control treatment
Active control (Conventional study)
Control: White bread
Quantity administered: 50g available carbohydrate portion
Frequency of administration: Once as part of the 5 arm within participant post-prandial study
Duration of control intervention: one breakfast meal (Conventional study)
Control group
Active

Outcomes
Primary outcome [1] 287024 0
Post-prandial satiety response by Labelled Magnitude Satiety line scale
Timepoint [1] 287024 0
Fasting then immediately,10, 25, 40, 55, 85, 115, 175 minutes after the start of the meal
Primary outcome [2] 287071 0
Post-prandial blood glucose response of finger prick blood samples using a glucometer
Timepoint [2] 287071 0
Fasting then 15, 30, 45, 60, 90 and 120 minutes after the start of the test meal
Primary outcome [3] 287072 0
Post-prandial insulin by ELISA assay of venous blood serum
Timepoint [3] 287072 0
Fasting then 30, 60, 120 and 180 minutes after the start of the test meal.
Secondary outcome [1] 297229 0
Ghrelin by ELISA assay on venous blood plasma
Timepoint [1] 297229 0
Fasting then 30, 60, 120 and 180 minutes after the start of the test meal
Secondary outcome [2] 297424 0
Isoprostane by High Performance Liquid Chromatography on venous blood plasma
Timepoint [2] 297424 0
Fasting then 30, 60, 120 and 180 minutes after the start of the test meal
Secondary outcome [3] 297425 0
Interleukin- 6 by ELISA Interleukin kit on venous blood plasma
Timepoint [3] 297425 0
Fasting then 30, 60, 120 and 180 minutes after the start of the test meal
Secondary outcome [4] 297426 0
Antioxidant capacity by Im An ox Kit on venous serum blood plasma
Timepoint [4] 297426 0
Fasting then 30, 60, 120 and 180 minutes after the start of the test meal
Secondary outcome [5] 297427 0
Nitric oxide by Micro ion selective method on venous blood plasma
Timepoint [5] 297427 0
Fasting then 30, 60, 120 and 180 minutes after the start of the meal
Secondary outcome [6] 297428 0
Chlorogenic acid by High Performance Liquid Chromatography on venous blood plasma
Timepoint [6] 297428 0
Fasting then 30, 60, 120 and 180 minutes after the start of the meal

Eligibility
Key inclusion criteria
30 healthy adults (from the general population)
Age range: 18 to 65 Years
BMI: 18.5- 29.5 Kg/m^2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Smokers
(2) Pregnant women
(3) Individuals consuming more than 3 alcoholic drinks per day (1 standard alcoholic drinks per day contains 10 g of pure alcohol)
(4) Individuals with food allergies
(5) People taking medication known to affect study parameters
(6) Individuals with eating disorders (Eating disorders will be determined by the 3 factor eating questionniare
(7) Individuals with history of the following conditons:
(a) Diabetes
(b) Cardiovascular diseases

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be done using a randomised table created by a computer software (computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
16/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285166 0
University
Name [1] 285166 0
Curtin University
Country [1] 285166 0
Australia
Funding source category [2] 285167 0
Commercial sector/Industry
Name [2] 285167 0
Horticulture Australia Limited ( HAL)
Country [2] 285167 0
Australia
Primary sponsor type
Individual
Name
Dr Stuart K Johnson (Principle Investigator)
Address
Room 361, Level 3
School of Public Health (Buliding 400)
Curtin University
Kent street
Bentley Campus
WA 6102
Country
Australia
Secondary sponsor category [1] 284033 0
Individual
Name [1] 284033 0
Associate Professor Vicky Solah
Address [1] 284033 0
Room 353, Level 3
School of Public Health (Buliding 400)
Curtin University
Kent street
Bentley Campus
WA 6102
Country [1] 284033 0
Australia
Secondary sponsor category [2] 284034 0
Individual
Name [2] 284034 0
Dr Tony James
Address [2] 284034 0
Room 358, Level 3
School of Public Health
Curtin University
Kent street
Bentley Campus
WA 6102
Country [2] 284034 0
Australia
Other collaborator category [1] 260789 0
Individual
Name [1] 260789 0
Ms Janine Wright
Address [1] 260789 0
Room 354, Level 3
School of Public Health
Curtin University
Kent street
Bentley Campus
WA 6102
Country [1] 260789 0
Australia
Other collaborator category [2] 260790 0
Individual
Name [2] 260790 0
Dr Cyril Mamotte
Address [2] 260790 0
Room 207, Level 2
School of Biomedical Sciences
Hayman road
Curtin University
Bentley Campus
WA 6102
Country [2] 260790 0
Australia
Other collaborator category [3] 260791 0
Individual
Name [3] 260791 0
Dr Le Jian
Address [3] 260791 0
Room 359, Level 3
School of Public Health
Kent Street
Curtin University
Bentley Campus
WA 6102
Country [3] 260791 0
Australia
Other collaborator category [4] 260792 0
Individual
Name [4] 260792 0
Dr Ya Ping Lee
Address [4] 260792 0
Room 207, Level 2
School of Pharmacy
Hayman road
Curtin University
Bentley Campus
WA 6102
Country [4] 260792 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287177 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 287177 0
Ethics committee country [1] 287177 0
Australia
Date submitted for ethics approval [1] 287177 0
04/04/2012
Approval date [1] 287177 0
31/05/2012
Ethics approval number [1] 287177 0
HR 47/2012

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

Contacts
Principal investigator
Name 34103 0
Address 34103 0
Country 34103 0
Phone 34103 0
Fax 34103 0
Email 34103 0
Contact person for public queries
Name 17350 0
Komal Tulsidas
Address 17350 0
School of Public Health
Curtin University
Kent street
Bentley
WA 6012
Country 17350 0
Australia
Phone 17350 0
+61 8 9266 4465
Fax 17350 0
+61 8 9266 2958
Email 17350 0
[email protected]
Contact person for scientific queries
Name 8278 0
Dr Stuart K Johnson
Address 8278 0
School of Public Health
Curtin University
Kent street
Bentley
WA 6102
Country 8278 0
Australia
Phone 8278 0
+61 8 9266 9486
Fax 8278 0
+61 8 9266 2958
Email 8278 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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