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Trial registered on ANZCTR


Registration number
ACTRN12611000396921
Ethics application status
Approved
Date submitted
14/04/2011
Date registered
14/04/2011
Date last updated
9/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The health effects of wheat breakfast cereals in overweight and obesity.
Scientific title
A randomised, double-blind, placebo controlled cross-over trial to measure the short and long term effects of wholegrain wheat breakfast cereals on biological markers, satiety and risk factors in adult males and females with overweight or obesity.
Secondary ID [1] 259862 0
Nil.
Universal Trial Number (UTN)
1111-1120-2980
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biological responses in obesity following wheat breakfast cereals. 265591 0
Appetite sensations. 265592 0
Condition category
Condition code
Diet and Nutrition 265736 265736 0 0
Obesity
Inflammatory and Immune System 265737 265737 0 0
Other inflammatory or immune system disorders
Metabolic and Endocrine 265738 265738 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will be testing 2 types of wheat breakfast cereals in short (2 hour) and extended (4 week) interventions by way of a randomised, double blind trial. During each arm, participants will consume an individualised breakfast dose of 1 of the 2 breakfast cereals based on their estimated energy requirements (EER) of no greater than 30% of their total energy requirements. The test cereals are both made from wholegrain wheat, they look and taste similar to common breakfast biscuit cereals, however one of the cereals has undergone an additional processing treatment that may have altered the nutritional composition of the cereal. In Arm 1, participants will be randomised to consume 1 of the test cereals, and arrive fasted for baseline blood collection followed by feeding, blood collection and appetite sensation recording over 2 hours. This is immediately followed by participants consuming the same test cereal daily for 4 weeks whilst otherwise maintaining their usual diet. Participants will visit the clinic weekly for monitoring, anthropometric measurements, and issue of cereal supply. At the end of 4 weeks participants will repeat testing to measure the response of eating the test cereal daily over 4 weeks. After a 2 week wash out period, Arm B commences with the same procedure as Arm A but with the alternate breakfast cereal.
Intervention code [1] 264375 0
Treatment: Other
Intervention code [2] 264376 0
Lifestyle
Comparator / control treatment
Active control - cross over. The control cereal is made from wholegrain wheat and looks and tastes similar to common wheat breakfast biscuits. The test cereal is also made from wholegrain wheat, however the grain used in the test cereal has undergone an additional processing treatment.
Control group
Active

Outcomes
Primary outcome [1] 266495 0
Glycemic responses, measured by fasting and postprandial glucose using capillary blood, and insulin from venous blood and indirect measurements (HOMA or QUICKI).
Timepoint [1] 266495 0
Fasting, and 30, 60, 90, 120 mins postprandial at baseline and 4 weeks for each arm (weeks 0, 4, 7, 10).
Primary outcome [2] 266514 0
Postprandial appetite responses over 2-hours, measured subjectively every 30 minutes by a 100mm Visual Analogue Scale, and biologically by appetite hormones (leptin, ghrelin, GLP-1) from fasting and postprandial blood samples.
Timepoint [2] 266514 0
Following randomised intervention, a Visual Analogue Scale will be administered postprandially at 30, 60, 90, 120 minutes at baseline and 4 weeks post intervention for each arm (weeks 0, 4, 7, 10), and venous blood collected at time 0 (fasting) and 120 minutes in the same weeks.
Primary outcome [3] 266515 0
Inflammatory response, measured by inflammatory markers associated with increased adiposity (IL-1B, 1L-6, TNF-a, CR-P and adiponectin), measured from a venous sample and analysed by an appropriate biomarker laboratory assay (eg ELISA or multiplex cytokine detection kit).
Timepoint [3] 266515 0
Time 0 (fasting) and 120 minutes postprandial at baseline and post 4-week intervention for each arm (weeks 0, 4, 7, 10).
Secondary outcome [1] 273936 0
Body weight (kg) measured in light clothing, no shoes, using a digital scale (Tanita InnerScan Body Composition Monitor Model BC-545).
Timepoint [1] 273936 0
Time 0 and 4 weeks post intervention for each arm (Weeks 0, 4, 7 and 10).
Secondary outcome [2] 273937 0
Body Mass Index (BMI) will be calculated by weight (kg)/height (m2). Weight will be measured by digital scale (Tanita InnerScan Body Composition Monitor Model BC-545) and height measured by stadiometer to the nearest 0.1cm.
Timepoint [2] 273937 0
Time 0 and 4 weeks post intervention for each arm (Weeks 0, 4, 7 and 10).
Secondary outcome [3] 273939 0
Daily energy intake, measured by 3-day food record.
Timepoint [3] 273939 0
Baseline and weekly during the 4-week intervention for each arm, (Weeks 0-4, 7-10).
Secondary outcome [4] 273940 0
Waist to hip ratio. Waist circumference to be measured using the mean of three measurements taken at the narrowest point between the lower costal (10th rib) border and the iliac crest. Hip measurement taken using a mean of three measurements at the level of the greatest posterior protuberance of the buttocks, whereby the tape is passed around the hips and maintained in the horizontal plane at the designated level.
Timepoint [4] 273940 0
Time 0 and 4 weeks post intervention for each arm (Weeks 0, 4, 7 and 10).
Secondary outcome [5] 273941 0
Resting heart rate, systolic and diastolic blood pressure will be measured taking the mean of three measurements, using an electronic blood pressure machine (Automated digital BP monitor A.N.D, UA- 767 Plus, A & D Medica), where the inflatable cuff of the sphygmomanometer is positioned around the upper arm at the level of the heart.
Timepoint [5] 273941 0
Baseline and post 4-week intervention for each arm (weeks 0, 4, 7, 10).
Secondary outcome [6] 273942 0
Serum lipids will be measured by venous blood sample and subsequent analysis using appropriate laboratory enzymatic assay.
Timepoint [6] 273942 0
Baseline and post 4-week intervention for each arm (weeks 0, 4, 7, 10).
Secondary outcome [7] 273943 0
Serum antioxidants, will be measured by venous blood sample and subsequent analysis using appropriate laboratory assay.
Timepoint [7] 273943 0
Baseline and post 4-week intervention for each arm (weeks 0, 4, 7, 10).
Secondary outcome [8] 273944 0
Percentage fat and lean mass using body composition scales (Tanita InnerScan Body Composition Monitor Model BC-545).
Timepoint [8] 273944 0
Baseline and post 4-week intervention for each arm (weeks 0, 4, 7, 10).

Eligibility
Key inclusion criteria
Overweight or obesity confirmed by Body Mass Index >25, and waist circumference >80cm (females) and 94cm (males). The BMI used will be adjusted for ethnicity where appropriate. Participants will be otherwise deemed healthy.
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to wheat, gluten, dairy or lactose.
Pregnancy or lactation.
Smoking.
Liver, kidney and heart disease.
Type 1 diabetes or type 2 diabetes with insulin medication.
Weight loss medication.
Participants that do not regularly consume breakfast or could not tolerate the same breakfast for the study period.
Unable to participate for the entire study period.
Excessive exercisers defined as significant levels of sport or strenuous leisure activity (30-60 minutes 4-5 times/week) or heavy occupational work (eg high performance athletes, farmers, construction workers, miners, forest workers).
Obesity caused by genetic factors or medication.
Neurological, endocrinological or other major systemic disease, including malignancy.
Acute illness or current evidence of acute or chrnoic inflammatory in infective disease.
Treatment for anaemia within the past 3 months.
Cirrhosis or chronic hepatitis.

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)
20 participants will be recruited from the University population by global email and electronic noticeboard, and pamphlets and posters will be distributed around the university and at local medical centres. After an initial enquiry, prospective participants will be sent an Information to Participants form outlining the details of the study. If interested, an interview will follow with questionnaire to determine the participant's health and whether the participant meets the inclusion and exclusion criteria. If all criteria are met, the participant is invited to join the study and a consent form is completed. Treatment allocation will be randomised and double blinded. The person determining the eligibility of participants for the trial will be unaware as to which treatment group the participant will be allocated to. Allocation will be by way of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book.
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
Recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3913 0
3021
Recruitment postcode(s) [2] 3914 0
3000
Recruitment postcode(s) [3] 3915 0
3023
Recruitment postcode(s) [4] 3916 0
3038
Recruitment postcode(s) [5] 3917 0
3037
Recruitment postcode(s) [6] 3918 0
3036
Recruitment postcode(s) [7] 3919 0
3033
Recruitment postcode(s) [8] 3920 0
3042

Funding & Sponsors
Funding source category [1] 264868 0
University
Name [1] 264868 0
Victoria University
Country [1] 264868 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
PO Box 14428
Melbourne, Vic 8001
Country
Australia
Secondary sponsor category [1] 263982 0
None
Name [1] 263982 0
Address [1] 263982 0
Country [1] 263982 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266829 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 266829 0
Ethics committee country [1] 266829 0
Australia
Date submitted for ethics approval [1] 266829 0
10/02/2011
Approval date [1] 266829 0
Ethics approval number [1] 266829 0
HRETH 11/14 (HREC 11/9)

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

Contacts
Principal investigator
Name 32364 0
Address 32364 0
Country 32364 0
Phone 32364 0
Fax 32364 0
Email 32364 0
Contact person for public queries
Name 15611 0
Kristina Nelson
Address 15611 0
School of Biomedical and Health Sciences
Victoria University
PO Box 14428
Melbourne, Vic 8001
Country 15611 0
Australia
Phone 15611 0
+61 3 9919 2625
Fax 15611 0
+61 3 9919 2465
Email 15611 0
kristina.nelson@live.vu.edu.au
Contact person for scientific queries
Name 6539 0
Professor Lily Stojanovska
Address 6539 0
School of Biomedical and Health Sciences
Victoria University
PO Box 14428
Melbourne, Vic 8001
Country 6539 0
Australia
Phone 6539 0
+61 3 9919 2737
Fax 6539 0
+61 3 9919 2465
Email 6539 0
lily.stojanovska@vu.edu.au

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
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Documents added automatically
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