Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000324819
Ethics application status
Approved
Date submitted
19/03/2012
Date registered
21/03/2012
Date last updated
21/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Research study investigating the effect of a meal on hunger and blood measurements related to health
Scientific title
Does pasta incorporated with sorghum flour induce lower post-meal glycemia, higher satiety and lower oxidative stress than control pasta without sorghum in healthy subjects?
Secondary ID [1] 280166 0
Nil
Universal Trial Number (UTN)
U1111-1129-2290
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-meal glycemia 286092 0
Satiety 286093 0
Antioxidant Capacity 286094 0
Oxidative Stress 286095 0
Condition category
Condition code
Diet and Nutrition 286286 286286 0 0
Obesity
Diet and Nutrition 286287 286287 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three types pasta products manufactured from either 100% durum wheat semolina or mixture of 70% durum wheat semolina and 30% red sorghum flour (red sorghum-containing pasta) and mixture of 70% durum wheat semolina and 30% white sorghum flour (white sorghum-containing pasta) will be used in this study.
Each of the 30 subjects recruited for the study will consume each of the 3 pasta products once only. The pasta products will be presented as breakfast on 3 separate morning, 7-14 days apart in a randomised crossover design, after an overnight fast of 10-12 hours.
Intervention code [1] 284492 0
Prevention
Intervention code [2] 284493 0
Treatment: Other
Comparator / control treatment
Control pasta made from 100% durum wheat semolina
Control group
Active

Outcomes
Primary outcome [1] 286757 0
Post-prandial glycemia by analysing capillary bloods samples by glucose meter (HemoCue 201)
Timepoint [1] 286757 0
At fasting and at 15, 30, 45, 60, 90 and 120 min after pasta consumption
Primary outcome [2] 286758 0
Plasma antioxidant capacity and plasma F2-isoprostane level (marker of oxidative stress) Microplate reader
Timepoint [2] 286758 0
At fasting and 120 min after pasta consumption
Secondary outcome [1] 296596 0
Perception of satiety using a 15 cm structured graphical scale
Timepoint [1] 296596 0
At fasting and at 15, 30, 45, 60, 90, 150 and 180 min after pasta consumption

Eligibility
Key inclusion criteria
Healthy subjects
Non-pregnant
Not having sensitivity to gluten
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy
Sensitivity to gluten
History of cardiovascular disease
Diabetes
Medications know to affect study parameters

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Thirty healthy subjects recruited through advertisement in newspapers, flyers and personal contact, will attend 3 sessions to consume the 3 test meals. The test meals will be administered in a random order assigned by computer-generated random numbers concealed in opaque envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Randomised, control crossover design
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5130 0
3125

Funding & Sponsors
Funding source category [1] 284915 0
University
Name [1] 284915 0
School of Exercise and Nutrition Sciences, Deakin University
Country [1] 284915 0
Australia
Primary sponsor type
University
Name
School of Exercise and Nutrition Sciences, Deakin University
Address
221 Burwood Highway, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 283790 0
None
Name [1] 283790 0
Address [1] 283790 0
Country [1] 283790 0
Other collaborator category [1] 260628 0
University
Name [1] 260628 0
School of Public Health, Curtin University
Address [1] 260628 0
Kent Street, Bentley, Perth, Western Australia. 6102.
Country [1] 260628 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286914 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 286914 0
Ethics committee country [1] 286914 0
Australia
Date submitted for ethics approval [1] 286914 0
20/01/2012
Approval date [1] 286914 0
21/02/2012
Ethics approval number [1] 286914 0
2012-009

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

Contacts
Principal investigator
Name 33939 0
Address 33939 0
Country 33939 0
Phone 33939 0
Fax 33939 0
Email 33939 0
Contact person for public queries
Name 17186 0
Imran Khan
Address 17186 0
School of Exercise and Nutrition Sciences, 221 Burwood Highway, Burwood ViC 3125
Country 17186 0
Australia
Phone 17186 0
+61(03)92446668
Fax 17186 0
Email 17186 0
[email protected]
Contact person for scientific queries
Name 8114 0
Imran Khan
Address 8114 0
School of Exercise and Nutrition Sciences, 221 Burwood Highway, Burwood ViC 3125
Country 8114 0
Australia
Phone 8114 0
+61(03)92446668
Fax 8114 0
Email 8114 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
EmbaseAcute effect of sorghum flour-containing pasta on plasma total polyphenols, antioxidant capacity and oxidative stress markers in healthy subjects: A randomised controlled trial.2015https://dx.doi.org/10.1016/j.clnu.2014.08.005
N.B. These documents automatically identified may not have been verified by the study sponsor.