Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001232921
Ethics application status
Approved
Date submitted
24/04/2009
Date registered
2/12/2011
Date last updated
2/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Breakfast calcium and prior exercise in obesity
Scientific title
Acute effects of dairy calcium and prior resistance exercise on fat oxidation in Caucasian adult obesity.
Secondary ID [1] 251761 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 4655 0
Condition category
Condition code
Diet and Nutrition 4958 4958 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was a single-blind, within subject, cross-over trial. Each postprandial laboratory visit was separated by a 2-week interval. Prior to the trial, subjects were required to attend introductory classes to resistance exercises (RE) 3 times per week for 2 consecutive weeks to familiarize themselves to the equipment and to be assigned the appropriate exercise intensity. Subjects were given one week break between the introductory classes and the start of the trial.

Subjects' meals prior to the exercise bout and the night prior to each postprandial visit were standardized. They received sachets of instant pasta meals to consume before the RE and frozen packs of rice and butter chicken to consume the night before each postprandial visit.

The breakfast meal served at the postprandial visit was either high (high calcium breakfast, HCB) or low (low calcium breakfast, LCB) in dairy calcium. They were made up of full-cream milk, rolled oats, sultanas, white sugar and whipping cream. A calcium supplement, extracted from milk, was added to the HCB to increase its calcium content. LCB was served with the prior RE session.

The nutritional composition of:
HCB - 537.01mg calcium, 1318.7kJ, 13.9% energy from protein, 54.7% energy from carbohydrate, 30.7% energy from fat
LCB - 257.25mg calcium, 1325.7kJ, 13.2% energy from protein, 55.5% energy from carbohydrate, 30.6% energy from fat

RE consisted of 4 sets of 10 exercises (bench press, leg press, seated row, partial dead lift, bicep curls, calf raises, upright row, abdominal curl, fixed leg dumbbell lunge, shoulder shrugs), each performed at 10 repetition maximum. A rest period of 1 minute was given between each exercise throughout the training session in a circuit-type workout. The acute RE session was conducted once, 16 hours prior to an LCB postprandial visit.

Subjects were randomized in either group A or B. Group A undertook the RE-LCB session first, followed by either LCB or HCB. If the 2nd postprandial visit was LCB, then the 3rd would be HCB and vice versa. Group B undertook the visits in the reverse order. Thus either LCB or HCB for the 1st and 2nd session and the RE-LCB session last. Since the trial is an acute study, there was no washout period required.

After consuming the provided dinner meal, subjects maintained a 12-14 hr overnight fast. Subjects rested for 30mins before having their resting metabolic rate measured for 30mins and fasting blood sample drawn. Subjects were required to consume the respective breakfast within 15mins, then rested for 15mins. Indirect calorimetry measurements, to assess substrate oxidation and diet-induced thermogenesis, were carried out for 30mins on the hour for 5 hours. A blood sample was taken after each indirect calorimetry measurement.
Intervention code [1] 4420 0
Lifestyle
Comparator / control treatment
low calcium breakfast (LCB)

Subjects were randomized in either group A or B. Group A undertook the RE-LCB session first, followed by either LCB or HCB. If the 2nd postprandial visit was LCB, then the 3rd would be HCB and vice versa. Group B undertook the visits in the reverse order. Thus either LCB or HCB for the 1st and 2nd session and the RE-LCB session last. Since the trial is an acute study, there was no washout period required.

Since resistance exercises have prolonged effect on substrate oxidation, subjects undertook the RE-LCB session either first or last.
Control group
Active

Outcomes
Primary outcome [1] 5807 0
Fat oxidation - assessed by indirect calorimetry using the Deltatrac II metabolic monitor (Datex Ohmeda, Helsinki, Finland).
Timepoint [1] 5807 0
After overnight fasting and every 30 min on the hour for 5 hours after breakfast
Secondary outcome [1] 241810 0
diet induced thermogenesis- assessed by indirect calorimetry using the Deltatrac II metabolic monitor (Datex Ohmeda, Helsinki, Finland).
Timepoint [1] 241810 0
After overnight fasting and every 30 min on the hour for 5 hours after breakfast
Secondary outcome [2] 241811 0
blood lipids and hormones - determined from blood samples using standard protocol for analysis
Timepoint [2] 241811 0
Blood was drawn after resting metabolic rate measurement and after each postprandial indirect calorimetry measurement.

Eligibility
Key inclusion criteria
Caucassian adults, body mass index >25 kg/m2, aged > 45 years, weight stable over last 6 months, sedentary to moderately active
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lactose intolerant, claustrophobic, suffering from major sytemic illness or gastrointestinal problems, on chronic prescribed medication.

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 by coin tossing
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
15/07/2004
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)

Funding & Sponsors
Funding source category [1] 4837 0
University
Name [1] 4837 0
Curtin University
Country [1] 4837 0
Australia
Primary sponsor type
Individual
Name
Mario Soares
Address
Program of Nutrition
School of Public Health
Curtin University
GPO Box U1987, Perth WA
Country
Australia
Secondary sponsor category [1] 4377 0
University
Name [1] 4377 0
Curtin University
Address [1] 4377 0
School of Public Health
GPO Box U1987, Perth
Western Australia 6845
Country [1] 4377 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6893 0
Human Research Ethics Committee
Ethics committee address [1] 6893 0
Ethics committee country [1] 6893 0
Australia
Date submitted for ethics approval [1] 6893 0
Approval date [1] 6893 0
14/06/2004
Ethics approval number [1] 6893 0
HR 73/2004

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

Contacts
Principal investigator
Name 29526 0
Address 29526 0
Country 29526 0
Phone 29526 0
Fax 29526 0
Email 29526 0
Contact person for public queries
Name 12773 0
Dr. Mario Soares
Address 12773 0
Program of Nutrition
School of Public Health
Curtin University of Technology
GPO Box U1987, Perth WA
Country 12773 0
Australia
Phone 12773 0
+61 8 9266 3220
Fax 12773 0
+61 8 9266 2958
Email 12773 0
[email protected]
Contact person for scientific queries
Name 3701 0
Dr Mario Soares
Address 3701 0
Program of Nutrition
School of Public Health
Curtin University of Technology
GPO Box U1987, Perth WA
Country 3701 0
Australia
Phone 3701 0
+61 8 9266 3220
Fax 3701 0
+61 8 9266 2958
Email 3701 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
No additional documents have been identified.