Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000624684
Ethics application status
Approved
Date submitted
5/06/2014
Date registered
13/06/2014
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
ABPA Study: Postprandial Metabolic Responses to Regular Activity Breaks and Physical Activity in Healthy Normal Weight Adults
Scientific title
Postprandial serum glucose, insulin, and triglyceride responses in healthy normal weight adults during prolonged sitting interrupted by regular activity breaks, physical activity or both.
Secondary ID [1] 284727 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged Sitting 292076 0
Postprandial lipidemia 292078 0
postprandial glycemia 292079 0
postprandial lnsulinemia 292080 0
Condition category
Condition code
Diet and Nutrition 292415 292415 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 292416 292416 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete, in random order, three intervention periods and one control period. Each period will be separated by six days and will be conducted on two consecutive days; 7.5 hours from 8:30 am to 4:00 pm on the first day, and 6 hours from 7:30 am to 1:30 pm on the second day.
The three interventions periods are as follows:
1. Physical activity: participants will walk on the treadmill at 60 % of maximal oxygen consumption (VO2max) for 30 min at the end of day one of the trial, at all other times they will be seated
2. Regular Activity Breaks: participants will walk on the treadmill at the same speed and incline as the physical activity intervention, for 2 min every 30 min throughout both day one and day two the trial
3. Regular activity breaks and physical activity: participants will walk on the treadmill for 2 min every 30 min throughout day one and two. In addition they will also complete 30 min of continuous walking at the end of day one. All walking on the treadmill will be at the same speed and incline as the physical activity intervention
The control period is:
Prolonged Sitting: participants will remain seated for the duration

On day one of each trial participants will be fed standardised meals at 15 and 205 min, and be provided with a standardised meal to consume at home during the evening between day one and two. On day two of each trial participants will be fed a standardised test meal providing 0.7 g fat per kg body mass at 0 min. At 305 min participants will be provided a buffet lunch.
Intervention code [1] 289510 0
Lifestyle
Comparator / control treatment
No Physical Activity. The Prolonged sitting intervention is the control condition. Participants will remain seated for the duration of the trial. Feeding will occur as in the other three trials.
Control group
Active

Outcomes
Primary outcome [1] 292281 0
Postprandial triglyceride response will be assessed by collecting blood samples at the time points listed below, and using them to calculate incremental area under the curve. Concentrations of triglycerides will be measured in each of these samples using enzymatic calorimetric methods.
Timepoint [1] 292281 0
Baseline day one, baseline day two, 20, 45, 60 120, 180, 240, 300 min after consumption of the test meal on day two
Primary outcome [2] 292282 0
Postprandial glucose response will be assessed by collecting blood samples at the time points listed below, and using them to calculate incremental area under the curve. Concentrations of glucose will be measured in each of these samples using enzymatic calorimetric methods
Timepoint [2] 292282 0
Baseline day one, baseline day two, 20, 45, 60 120, 180, 240, 300 min after consumption of the test meal on day two
Primary outcome [3] 292283 0
Postprandial insulin response will be assessed by collecting blood samples at the time points listed below, and using them to calculate incremental area under the curve. Concentrations of insulin will be measured in each of these samples using an electrochemiluminescent immunoassay
Timepoint [3] 292283 0
Baseline day one, baseline day two, 20, 45, 60 120, 180, 240, 300 min after consumption of the test meal on day two
Secondary outcome [1] 308616 0
Postprandial non esterified fatty acids (NEFA) response will be assessed by collecting blood samples at the time points listed below, and using them to calculate incremental area under the curve. Concentrations of NEFA will be measured in each of these samples using enzymatic calorimetric methods
Timepoint [1] 308616 0
Baseline day one, baseline day two, 20, 45, 60 120, 180, 240, 300 min after consumption of the test meal on day two
Secondary outcome [2] 308617 0
Substrate utilisation and energy expenditure will be measured by indirect calorimetry
Timepoint [2] 308617 0
Day one: baseline, 105, 225, 345, 400 and 435 min
Day two: baseline, 75, 195 and 285 min
Secondary outcome [3] 308618 0
Energy intake will be measured by calculation the energy content of all food consumed during the study.
Timepoint [3] 308618 0
Day one: 15, 205 and 630 min'
Day two: 0 and 305 min
Secondary outcome [4] 308619 0
Appetite will be measured by questionnaire which will ask participants to rate their feelings of hunger, and satiety on a 10 cm visual analogue scale
Timepoint [4] 308619 0
Day one: baseline, 30, 90, 150, 200, 220, 270, 330, 390 min
Day two: baseline, 15, 60, 120, 180, 240, 300, 335 min

Eligibility
Key inclusion criteria
Healthy men and women who do not regularly undertake more than 3 hours of physical activity a week, and have a predominantly sedentary occupation
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy; or planning a pregnancy in the next four months
A personal history of cardiovascular disease; metabolic syndrome, diabetes, or dislipidemia;
Bleeding tendency, abnormal bruising or coagulation disorder;
Smoker;
On medication known to influence lipid or carbohydrate metabolism;
Employment in a non-sedentary occupation;
Regular participation in more than 150 min of moderate to vigorous physical activity;
Contraindications for participating in physical activity
Intolerance/Allergy to gluten or dairy

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)
Participants will initially attend a screening visit at which blood pressure and fasting lipid and glucose concentrations will be measured. If blood pressure, glucose and lipids are within the acceptable range participants will complete an aerobic capacity test (VO2max). Participants will then complete the four trial conditions in a predetermined randomized order. The randomization code will be sealed in opaque envelopes. An envelope will be opened prior to each participant's first session, and the code contained within will dictate the order the interventions will be completed by that participant
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
STATA software will be used to generate the randomization sequence for the order the interventions will be performed for each participant.
Masking / blinding
Open (masking not 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
30/06/2014
Actual
30/06/2014
Date of last participant enrolment
Anticipated
Actual
29/09/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 6093 0
New Zealand
State/province [1] 6093 0
Otago

Funding & Sponsors
Funding source category [1] 289344 0
Charities/Societies/Foundations
Name [1] 289344 0
National Heart Foundation of New Zealand
Country [1] 289344 0
New Zealand
Funding source category [2] 289345 0
Government body
Name [2] 289345 0
Lottery Grants Board
Country [2] 289345 0
New Zealand
Funding source category [3] 289346 0
University
Name [3] 289346 0
University of Otago Research Grant
Country [3] 289346 0
New Zealand
Primary sponsor type
Individual
Name
Meredith Peddie
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 288029 0
Individual
Name [1] 288029 0
Tracy Perry
Address [1] 288029 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country [1] 288029 0
New Zealand
Other collaborator category [1] 277988 0
Individual
Name [1] 277988 0
Nancy Rehrer
Address [1] 277988 0
School of Physical Education, Sport and Exercise Sciences
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country [1] 277988 0
New Zealand
Other collaborator category [2] 277989 0
Individual
Name [2] 277989 0
Murray Skeaff
Address [2] 277989 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country [2] 277989 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291114 0
University of Otago Human Ethics Committee
Ethics committee address [1] 291114 0
Ethics committee country [1] 291114 0
Date submitted for ethics approval [1] 291114 0
Approval date [1] 291114 0
28/03/2013
Ethics approval number [1] 291114 0
13/112

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

Contacts
Principal investigator
Name 48918 0
Dr Meredith Peddie
Address 48918 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country 48918 0
New Zealand
Phone 48918 0
+64 3 479 5673
Fax 48918 0
Email 48918 0
[email protected]
Contact person for public queries
Name 48919 0
Meredith Peddie
Address 48919 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country 48919 0
New Zealand
Phone 48919 0
+64 3 479 5673
Fax 48919 0
Email 48919 0
[email protected]
Contact person for scientific queries
Name 48920 0
Meredith Peddie
Address 48920 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country 48920 0
New Zealand
Phone 48920 0
+64 3 479 5673
Fax 48920 0
Email 48920 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
EmbaseRegular activity breaks combined with physical activity improve postprandial plasma triglyceride, nonesterified fatty acid, and insulin responses in healthy, normal weight adults: A randomized crossover trial.2017https://dx.doi.org/10.1016/j.jacl.2017.06.007
N.B. These documents automatically identified may not have been verified by the study sponsor.