Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000418279
Ethics application status
Approved
Date submitted
22/04/2009
Date registered
9/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The ability of dietary calcium to influence fat oxidation, glucose levels and satiety in caucasian adults.
Scientific title
The role of calcium in the modulation of postprandial substrate oxidation following sequential meals in caucasian human subjects.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 4644 0
Condition category
Condition code
Diet and Nutrition 4947 4947 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized, within-subject trial comparing two breakfast-lunch combinations that only differ in calcium content of breakfast (~250mg versus 550mg). Each combination will be adminstered on one occassion only, in a random order. Volunteers will crossover to the second combination following a 2 week washout period. Breakfast will consist of rolled oats, sultanas, cream, milk and sugar while lunch will consist of a white bread sandwich of ham, tomato, butter with a serving of fruit and fruit juice.
Intervention code [1] 4407 0
Lifestyle
Intervention code [2] 4408 0
Prevention
Comparator / control treatment
The low calcium (~250mg) breakfast-standard lunch combination is the comparator treatment. Each breakfast-lunch combination will be adminstered on one occassion only, in a random order, and volunteers will crossover to the alternative combination following a 2 week washout period.
Control group
Active

Outcomes
Primary outcome [1] 5795 0
Whole body fat oxidation based on indirect calorimetry
Timepoint [1] 5795 0
Baseline and every 30 minutes for 8 hours following consumption of breakfast meal.
Secondary outcome [1] 241789 0
subjective hunger/satiety ratings using 10 cm visual analogue scales.
Timepoint [1] 241789 0
Baseline and every 30 minutes for 8 hours following consumption of breakfast meal.
Secondary outcome [2] 241790 0
insulin and glucose responses from venous blood samples
Timepoint [2] 241790 0
Baseline and every 30 minutes for 8 hours following consumption of breakfast meal.
Secondary outcome [3] 241791 0
Reported food intake using a food diary
Timepoint [3] 241791 0
A buffet meal will be served 4 hr after lunch and will consist of a choice of bread, pumpkin soup, cheese, carrot sticks, crackers, almonds, apricots, baked apple bar, fruit in juice, milk chocolate, orange juice, tea and coffee. Volunteers will record their food intake for 30h after the buffet.

Eligibility
Key inclusion criteria
Caucasian adults, body mass index >20 kg/m2, weight stable over last 6 months, < 2 alcoholic drinks per day.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
lactose intolerance or gastrointestinal disturbances, hormone replacement therapy, medications for systemic diseases or vitamin/mineral supplements

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 through coin toss
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
Completed
Date of first participant enrolment
Anticipated
12/05/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1675 0
6100
Recruitment postcode(s) [2] 1676 0
6102
Recruitment postcode(s) [3] 1677 0
6152
Recruitment postcode(s) [4] 1678 0
6000

Funding & Sponsors
Funding source category [1] 4825 0
Commercial sector/Industry
Name [1] 4825 0
Dairy Australia
Country [1] 4825 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
School of Public Health
GPO Box U1987,
Bentley Campus Perth WA 6845
Country
Australia
Secondary sponsor category [1] 4367 0
Individual
Name [1] 4367 0
Dr Mario Soares
Address [1] 4367 0
School of Public Health
Program of Nutrition,
GPO Box U1987,
Bentley Campus Perth WA 6845
Country [1] 4367 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6882 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 6882 0
Office of Research & Development
Curtin University of Technology
GPO Box U1987,
Bentley Campus, Perth WA 6845
Ethics committee country [1] 6882 0
Australia
Date submitted for ethics approval [1] 6882 0
Approval date [1] 6882 0
17/04/2003
Ethics approval number [1] 6882 0
HR 42/2003

Summary
Brief summary
The primary purpose of this study is to examine whether a change in calcium intake at one meal modifies the way in which we handle the subsequent meal. We believe that increasing calcium intake at breakfast improves the body's ability to handle glucose following lunch, while promoting utilization of fat and suppressing subjective ratings of hunger.
Trial website
Trial related presentations / publications
M J Soares and W Chan She Ping-Delfos. Second meal effects of dietary calcium and vitamin D. European Journal of Clinical Nutrition (2008) 62, 872–878; doi:10.1038/sj.ejcn.1602803; published online 23 May 2007.
Public notes

Contacts
Principal investigator
Name 29519 0
Address 29519 0
Country 29519 0
Phone 29519 0
Fax 29519 0
Email 29519 0
Contact person for public queries
Name 12766 0
Dr. Mario Soares
Address 12766 0
School of Public Health
GPO Box U1987,
Bentley Campus Perth WA 6845
Country 12766 0
Australia
Phone 12766 0
+61 8 9266 3220
Fax 12766 0
+61 8 9266 2958
Email 12766 0
[email protected]
Contact person for scientific queries
Name 3694 0
Dr. Mario Soares
Address 3694 0
School of Public Health
GPO Box U1987,
Bentley Campus Perth WA 6845
Country 3694 0
Australia
Phone 3694 0
+61 8 9266 3220
Fax 3694 0
+61 8 9266 2958
Email 3694 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
EmbaseDiet induced thermogenesis, fat oxidation and food intake following sequential meals: Influence of calcium and vitamin D.2011https://dx.doi.org/10.1016/j.clnu.2010.11.006
N.B. These documents automatically identified may not have been verified by the study sponsor.