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Trial registered on ANZCTR


Registration number
ACTRN12616000439448
Ethics application status
Approved
Date submitted
24/03/2016
Date registered
6/04/2016
Date last updated
6/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of carob nutrients on glycaemic and appetite responses.
Scientific title
Investigation of the consumption of high pinitol carob fibre on glycaemic and insulinaemic response on appetite in humans.
Secondary ID [1] 288932 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood glucose attenuation within healthy/overweight subjects 298121 0
Appetite in normal weight/overweight individuals 298124 0
Condition category
Condition code
Diet and Nutrition 298287 298287 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 298354 298354 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pinitol has been shown to demonstrate insulin signalling and the stimulation of glucose transport in humans. Research shows that carob is very high in pinitol in comparison to other legume products. Therefore, carob is a much viable source.
Three test foods will be consumed by 20 (15 people minimum) participants in a double-blind crossover design containing a control and two test meals. The control biscuit will contain moderate fibre within a commercial cereal-based biscuit (control), test meal one will contain high pinitol carob fibre (HPCF) and test meal two will contain a low pinitol carob fibre (LPCF).

CONTROL
Energy: 915 KJ
Carob ingredient: 0 g
Pinitol: 0 mg
Carbohydrate: 33.1 g
Dietary fibre: 3.8 g

TEST MEAL 1 (HPCF)
Energy: Approx. 900 KJ
Carob ingredient: 6 g
Pinitol: 600 mg
Carbohydrate: 33 g
Dietary fibre: 6 g

TEST MEAL 2 (LPCF)
Energy: Approx. 900 KJ
Carob ingredient: 6 g
Pinitol: <100 mg
Carbohydrate: 33 g
Dietary fibre: 6 g

Two nutrition and dietetics honours students will be deliver the intervention, while the blood samples will be taken by trained nurse staff. The supervisors of this intervention are both trained as dieticians.
Values will be determined after testing final product.
Participants are required to have fasted overnight (12-hours).

All three test foods will be consumed on separate occasions, with at least a 72 hour washout period. Blood samples taken to measure the effects of a high pinitol carob fibre (HPCF) cereal-based biscuit on glycaemic and insulin responses on appetite within humans.

Adherence will be measured by using a 24-hour recall to monitor dietary intake the day before testing was maintained. As there is 3 separate, acute, testing days, subjects will only be required to maintain habitual dietary patterns.
Intervention code [1] 294295 0
Treatment: Other
Comparator / control treatment
The control test food will contain a moderate fibre test food within a commercial cereal-based biscuit containing no carob or pinitol product.

CONTROL
Energy: 915 KJ
Carob ingredient: 0 g
Pinitol: 0 mg
Carbohydrate: 33.1 g
Dietary fibre: 3.8 g

The control will contain insoluble fibre in the form of wholegrain cereal (wheat products). Carob is also high in insoluble fibre, therefore allowing a comparison.
Control group
Active

Outcomes
Primary outcome [1] 297771 0
Differences in glycaemic responses between control and test foods. This will be done by taking blood samples throughout the testing day.
Timepoint [1] 297771 0
Area under the curve responses over a 3-hour period (0, 15, 30, 60, 120, 180 minutes).
Primary outcome [2] 297774 0
Differences in insulin responses between test foods will be measured throughout testing day with blood samples.
Timepoint [2] 297774 0
Area under the curve responses over a 3-hour period (0, 15, 30, 60, 120, 180 minutes).
Secondary outcome [1] 322171 0
Differences in subjective satiety between control and test meals. This will be achieved by using a Visual Analogue Scale (VAS).
Timepoint [1] 322171 0
Feedback given through a questionnaire over a 3-hour period (0, 15, 30, 60, 120, 180 minutes).
Secondary outcome [2] 322179 0
Meal intake data at subsequent meal/s. Sandwiches will be provided to the subjects all containing a similar nutritional profile. Subjects are encouraged to eat as much as they desire, food will be weighed before and after to estimate dietary intake to compare with VAS scores. Intake will be analysed through Foodworks software (Xyris P/L Brisbane, Australia).
Timepoint [2] 322179 0
3-hours after test meal has been consumed, an ad libitum lunch will be provided. Subjects may take as long or little time to consume what is necessary.

Eligibility
Key inclusion criteria
Overall good health, between the age of 18-60 years and a body mass index between 20-30 kg/m^2 (healthy to overweight range).
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects with major or chronic diseases, eating habits incompatible with the studies aims (food allergies and/or religious, cultural or environmental habits that don’t correspond with the study), literacy and/or inadequate English. Pregnant, breastfeeding or women with menstrual irregularities (based on hormonal appetite), smoking, the use of antioxidant supplementation within four-weeks of the study commencement date and the unwillingness to stop fibre supplements will also be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation (randomised ordering of test days) is performed by a statistician external to the research team. The researcher with the patient contact will contact the statistician after enrolment to gain allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is by computer generated permuted block randomisation.
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
Researchers blinded until final data analysed.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Previous studies identified that to detect biochemical differences,as few as seven subjects of each sex may be sufficient, while 18 subjects should identify statistically significant changes using a paired design and a study power of 0.8 if VAS ratings vary by at least 5 mm [FLINT, 2000]. Using a repeated
measures design would decrease this number possibly, however, a target of 20 subjects was set for recruitment based on these studies to ensure at least 18 subjects complete the study.

Flint, A., Raben, A., Blundell, J. E., Astrup, A., 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293199 0
University
Name [1] 293199 0
University of Wollongong
Address [1] 293199 0
Northfields Ave, Wollongong NSW 2522.
Country [1] 293199 0
Australia
Funding source category [2] 293200 0
Commercial sector/Industry
Name [2] 293200 0
Sanitarium Health and Wellbeing
Address [2] 293200 0
1 Sanitarium Drive
Berkeley Vale NSW 2261
Country [2] 293200 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Faculty of Science Medicine and Health
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 292003 0
Commercial sector/Industry
Name [1] 292003 0
Sanitarium Health and Wellbeing
Address [1] 292003 0
1 Sanitarium Drive
Berkeley Vale NSW 2261
Country [1] 292003 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294685 0
University of Wollongong, Human Research Ethics Committee
Ethics committee address [1] 294685 0
Northfields Ave
Wollongong NSW 2522
Ethics committee country [1] 294685 0
Australia
Date submitted for ethics approval [1] 294685 0
27/02/2016
Approval date [1] 294685 0
30/03/2016
Ethics approval number [1] 294685 0
HE16/033

Summary
Brief summary
This project aims to substantiate the effects of acute ingestion of high pinitol carob fibre on glycaemic control and subjective satiety and appetite responses. A secondary aim is to distinguish any additional clinically relevent effects of the pinitol compared to the fibre alone. We hypothesise that high pinitol carob fibre within a cereal-based test food will lower glycaemic and insulinaemic responses and increase satiety resulting in lower dietary intake.
Trial website
N/A
Trial related presentations / publications
Nil to date
Public notes
This project will also provide human evidence of any positive health effects of carob ingredients supporting Australian carob producers in novel uses of their products.

Contacts
Principal investigator
Name 64102 0
A/Prof Eleanor Beck
Address 64102 0
School of Medicine
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 64102 0
Australia
Phone 64102 0
+61242981271
Fax 64102 0
Email 64102 0
eleanor@uow.edu.au
Contact person for public queries
Name 64103 0
A/Prof Eleanor Beck
Address 64103 0
School of Medicine
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 64103 0
Australia
Phone 64103 0
+61242981272
Fax 64103 0
Email 64103 0
eleanor@uow.edu.au
Contact person for scientific queries
Name 64104 0
A/Prof Eleanor Beck
Address 64104 0
School of Medicine
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 64104 0
Australia
Phone 64104 0
+61242981271
Fax 64104 0
Email 64104 0
eleanor@uow.edu.au

No information has been provided regarding IPD availability
Summary results
No Results