Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000726752
Ethics application status
Approved
Date submitted
6/06/2013
Date registered
1/07/2013
Date last updated
1/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of wholegrain breakfast meals on appetite
Scientific title
Will eating a wholegrain breakfast meal with slower starch digestibility and higher polyphenol content result in greater post-prandial satiety, lower energy intake at a subsequent meal and greater antioxidant effects in healthy adults?
Secondary ID [1] 281636 0
NIL
Universal Trial Number (UTN)
U1111-1137-7803
Trial acronym
WAS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 287922 0
Appetite Regulation 288744 0
Condition category
Condition code
Metabolic and Endocrine 288302 288302 0 0
Normal metabolism and endocrine development and function
Metabolic and Endocrine 289843 289843 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Participants will undergo 3 test meals and 1 control meal. The order they receive the meals will be randomised.

Test meals: 45grams of flaked wholegrain cereal biscuits derived from 3 different varieties of sorghum grain. The different test biscuits that are expected to have variable rates of starch digestibility and polyphenol content.

Control meal: 45g wholegrain breakfast meal using comparator cereals.

Duration of administration: Breakfast meals and subsequent 4 hours, following 12 hours overnight fast with a prior standardised dinner the night before.

Time of administration: Morning breakfast meal.

Frequency of administrations:
4 test days separated by a minimum 3-7 day washout period.
Females will be tested during the same phase of their menstrual cycle.
Intervention code [1] 286173 0
Treatment: Other
Intervention code [2] 286840 0
Prevention
Comparator / control treatment
Control breakfast meal based on a wholegrain cereal different to the test meals - equal in mass (45g) and with similar macronutrient profile
Control group
Active

Outcomes
Primary outcome [1] 288475 0
Food (mass)/Energy (kJ) and nutrient intake to be assessed at a subsequent (ad libitum) meal at time-point 240minutes.

Food (mass)/Energy (kJ) and nutrients consumed during the remainder of the test day will also be assessed.

Weighed food measures and diet history assessments will be used to determine this outcome.
Timepoint [1] 288475 0
Ad libitum meal will be consumed at time-point 240 minutes.

Food intake for remainder of the day will be assessed from time of completion of ad libitum meal to end of day.
Secondary outcome [1] 300266 0
Perception of post-prandial satiety as measured by 10mm Visual Analogue Scales
Timepoint [1] 300266 0
At fasting then 15, 30, 60, 90, 120, 180 and 240 minutes.
Secondary outcome [2] 302044 0
Post prandial blood glucose and insulin response will be collected by investigators and then sent to a quality assured pathology for analysis (Cardinal Labs QLD, Southern IML Pathology Wollongong).
Timepoint [2] 302044 0
At fasting then 15, 30, 60, 90, 120, 180 and 240 minutes.
Secondary outcome [3] 302045 0
Appetite hormone - PYY - assay performed by Cardinal Labs QLD
Timepoint [3] 302045 0
At fasting then 15, 30, 60, 120, 180, 240.
Secondary outcome [4] 302046 0
Appetite hormone - GPL-1 - assay performed by Cardinal Labs QLD
Timepoint [4] 302046 0
At fasting then 15, 30, 60, 120, 180, 240 minutes.
Secondary outcome [5] 302047 0
Appetite hormone - Ghrelin - assay performed by Cardinal Labs QLD
Timepoint [5] 302047 0
At fasting then 15, 30, 60, 120, 180, 240 minutes.
Secondary outcome [6] 302048 0
Appetite hormone - GIP - assay performed by Cardinal Labs QLD
Timepoint [6] 302048 0
At fasting then 15, 30, 60, 120, 180, 240 minutes.
Secondary outcome [7] 302049 0
Total antioxidant capacity of plasma as an indicator of antioxidant potential of components in test meals.

The method for analysis will include adding a known amount of oxidising reagent and measuring the capacity of the sample to eliminate oxidants - the residual oxidant is measured photometrically.
Timepoint [7] 302049 0
At fasting then 60, 120, 180 minutes.
Secondary outcome [8] 302050 0
Blood pressure.

Blood pressure will be monitored using an Omron M3 Automatic Blood Pressure Monitor.
Timepoint [8] 302050 0
At fasting then 60, 120, 180, 240 minutes.
Secondary outcome [9] 303157 0
Sensory perception of test meals - assessed by VAS questionnaire
Timepoint [9] 303157 0
Between 0 and 15 minutes.

Eligibility
Key inclusion criteria
18-50 year old men and women
Willing to attend research facility on 4 occasions for a period of 5 hours plus an initial pre-study interview for 1.5hours.
BMI 18.5-33
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwilling to consume a breakfast meal comprising of wholegrain cereal with water on four occasions
Existing allergies/intolerances to wheat or gluten
Smokes cigarettes
Know or suspect pregnancy or are breastfeeding
Diabetes
Major illnesses
BMI <18.5 and >33
Have been taking antioxidant supplements, Vit C within 2 weeks of study (if randomised into bloods group)
Irregular menstrual period
Iron deficiency
Cannot understand English

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)
Participants will be drawn from the general public through media advertisements (local newspapers), institutional electronic messaging to students and staff of UOW and local primary school newsletters.

This study is powered to assess outcomes with 40 participants and 20 of these to be randomised into a sub-group to undertake blood sampling. A researcher independent of the subject interface will undertake the randomisation of subjects as to the order they ingest the test meals and also for the selection of the sub-group to participate in the blood sample collection.

Participants will be informed the study involves wholegrain cereal products but not regarding the specific meal components or the specific component being tested.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Williams design 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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mix model

Taking into consideration statistical expert opinion and the collective sample sizes in the referenced studies below (of similar study design as ours), we conclude that 40 participants in total to undergo subjective appetite studies through VAS AND of this group a 20 participant subset for biochemical marker analysis is required to achieve significant results. Importantly, the fact that no studies have previously investigated the effects of sorghum in humans warrants a larger sample size than in some of the studies referenced below, particularly in relation to the biochemical markers.

Justification for 20 subjects for blood studies (using GIP and GLP-1 as an example):

Najjar A.M. et al. BJN (2009) 101, 391-398: The acute impact of ingestion of breads of varying composition on blood glucose, insulin and incretins following first and second meals

Maersk M. EJCN (2012): Satiety scores and satiety hormone response after sucrose-sweetened soft drink compared with isocaloric semi-skimmed milk and with non-caloric soft drink: a controlled trial

Justification for 35-40 subjects for VAS studies:

Flint A., Raben A, et al. International Journal of Obesity (2000) 24, 38-48: Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies
-an effect size of 10% would be a reasonable and realistic difference to look for in studies of appetite. With a study power of 0.8 and using a paired design, 32 subjects will be enough to test all parameters.

Lemmens S.G ,et al. AJCN (2011) Changes in gut hormone and glucose concentrations in relation to hunger and fullness
-38 subjects in an acute meal study comparing VAS scores with glucose and hormone concentrations (including GIP, GLP-1, ghrelin, insulin) over time in a randomized crossover design. Significance was achieved.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6113 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 286442 0
Government body
Name [1] 286442 0
Australian Research Council
Country [1] 286442 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sanitarium
Address
Locked Bag 7
Central Coast Mail Centre
NSW 2252
Australia
Country
Australia
Secondary sponsor category [1] 285229 0
None
Name [1] 285229 0
Address [1] 285229 0
Country [1] 285229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288519 0
Ethics Unit, Research Services Office at the University of Wollongong
Ethics committee address [1] 288519 0
Ethics committee country [1] 288519 0
Australia
Date submitted for ethics approval [1] 288519 0
Approval date [1] 288519 0
13/11/2012
Ethics approval number [1] 288519 0
HE12/410

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

Contacts
Principal investigator
Name 36466 0
Prof Linda Tapsell
Address 36466 0
Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 36466 0
Australia
Phone 36466 0
+61 42213152
Fax 36466 0
Email 36466 0
[email protected]
Contact person for public queries
Name 36467 0
Anita Needham
Address 36467 0
School of Health Sciences
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 36467 0
Australia
Phone 36467 0
+61 42981344
Fax 36467 0
Email 36467 0
[email protected]
Contact person for scientific queries
Name 36468 0
Anita Needham
Address 36468 0
School of Health Sciences
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 36468 0
Australia
Phone 36468 0
+61 42981344
Fax 36468 0
Email 36468 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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