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Trial registered on ANZCTR


Registration number
ACTRN12615001216505
Ethics application status
Approved
Date submitted
4/11/2015
Date registered
6/11/2015
Date last updated
13/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of energy distribution across three main daily meals during prolonged sitting on the regulation of blood glucose
Scientific title
Effects of a larger meal at breakfast or at dinner during prolonged sitting in pre-diabetic overweight/obese older adults on the regulation of blood glucose
Secondary ID [1] 287754 0
None
Universal Trial Number (UTN)
U1111-1176-0075
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 296625 0
Overweight/obesity 296626 0
Condition category
Condition code
Diet and Nutrition 296864 296864 0 0
Obesity
Metabolic and Endocrine 296938 296938 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete 2 x 36 h periods of activity (using ActivPal monitors) and glucose (using continous blood glucose monitors) monitoring.
Participants will spend one day at the laboratory (between 7.30 am and 7 pm) during each of the 36 h periods.
Prior to the trial day, participants will receive a standardised meal to take home and consume for their last meal of the day, have finger prick blood samples taken, have a continuous blood glucose monitor (CGM) inserted subcutaneously on their lower back and have an ActivPal activity monitor adhered to their thigh. This appointment will take ~1 h prior to trial day.
On a trial day, participants will get a taxi (costs covered by the study) to the laboratory. An indwelling cannula will be inserted into an anticubital vein of the forearm, and the study involves having serial blood measures and answering appetite questionnaires for the duration of a day (8 am to 5 pm) whilst remaining seated. Meals will be provided for breakfast (9am), lunch (1 pm) and dinner (6 pm) to consume at the laboratory.
At the end of the trial day, participants will be taxied home, and they will wear the CGM and the Activpal until 8 am the next morning.
Trials will be separated by at least a 7 day period.

Condition A: Energy intake is distributed with 20% of energy at breakfast, 30% of energy at lunch and 50% of energy at dinner.
Condition B: Energy intake is distributed with 50% of energy at breakfast, 30% of energy at lunch and 20% of energy at dinner.

For both dietary interventions the macronutrient distribution will be the same (i.e. 50% energy from carbohydrate, 20% energy from protein and 30% energy from fat)..

Participants will complete food and activity diaries across the period encompassing the day prior to and the day after each trial day to ensure adherence. Whilst in the laboratory, participants will be monitored by the research staff.
Intervention code [1] 293148 0
Other interventions
Comparator / control treatment
The participants act as their own control (where Condition A is the control condition) and complete both dietary conditions.
Control group
Active

Outcomes
Primary outcome [1] 296466 0
Change in blood glucose area under the curve using subcutaneous continuous blood glucose monitors, validated with serial finger prick samples.
Timepoint [1] 296466 0
Pre to post intervention (i.e. from insertion the night before trial day to 8 am on the day after trial day), including the 4-h postprandial periods, with finger prick samples at 1 h post insertion (i.e. 5 pm of the day before), prior to breakfast, prior to lunch, prior to dinner and the morning after the trial.
Primary outcome [2] 302114 0
Change in blood glucose area under the curve using venous plasma samples obtained throughout a day
Timepoint [2] 302114 0
Measured from 8 am to 6 pm inclusively, every hour as well as 30 min post meals, to calculate mean glucose, total area under the curve (AUC), and postprandial incremental AUC in the 4-h period post meals.
Secondary outcome [1] 318509 0
Changes in measures of appetite measured through ratings of perceived levels of hunger and satiety (“fullness”) Appetite scores for hunger and satiety will be assessed using 100-mm visual analogue scales (VAS) on a computer based program on a laptop and be asked to mark their perceived hunger rating on a 0 to 100 likert scale (from not at all hungry to very hungry) to indicate their feelings at that time-point.
Timepoint [1] 318509 0
These will be measured before and every 60 min after breakfast, lunch and dinner.
Secondary outcome [2] 318519 0
Plasma triglyceride response
Timepoint [2] 318519 0
Measured hourly across the 8 hour laboratory period.
Secondary outcome [3] 318728 0
Plasma insulin response
Timepoint [3] 318728 0
Measured hourly across the 8 hour laboratory period.
Secondary outcome [4] 320028 0
Sleep quality
Timepoint [4] 320028 0
Assessed prior to the intervention (3 nights) and each trial intervention night, using a sleep questionnaire and with participants wearing an accelerometer device.
Secondary outcome [5] 320029 0
Neurocognitive and mood assessments using 12 standardised, reliable and valid neurocognitive measures and a standard mood questionnaire
Timepoint [5] 320029 0
At baseline compared to the morning after each trial day

Eligibility
Key inclusion criteria
Presenting as pre-diabetic - [by having a fasting blood glucose greater than 5.9 mmol/L and/or a 2 hour oral glucose tolerance test blood glucose between 7.8 mmol/L and 11.0 mmol/L]
Being overweight or obese - [body mass idex (BMI) greater than 25 kg/m2 and less than 45 kg/m2
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded on the basis of: pregnancy; use of carbohydrate or lipid-lowering medication if it has been commenced within 3 months; bariatric surgery (gastric bypass or banding); employment in a non-sedentary occupation; currently watching less than 3 hours of television or computer use per day; regularly engaged in moderate-intensity exercise for greater than 150 min/week for more than 3 months; major illness/injury (acute or chronic), current smoker or use of nicotine replacement therapy; or physical or major illness/physical problems (acute or chronic) that may limit their ability to participate in the intervention

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer-generated, randomised sequence. An independent third party will prepare the computer-generated randomisation lists and sealed envelopes for randomisation. Once informed consent is obtained, the sealed randomisation envelope will be opened revealing the trial-condition order.
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
Statistical analysis
Generalized linear mixed models (GLMMs) with random intercepts will be used to evaluate the differential effects of the experimental conditions on the outcomes. All models will include a binary variable indicating the experimental condition (BF or D), adjusted for potential period effects and period-dependent confounders (baseline values for the outcome of interest, dietary intake and physical activity). Given that the study uses a balanced orthogonal design and substantial imbalances due to dropout are unlikely, it will not be necessary to adjust for subject-level covariates (e.g., age). GLMMs are appropriate for correlated data (repeated measures) with various distributional assumptions and can easily accommodate missing data. A probability level of 0.05 will be adopted.

Power Calculations
Power calculations have been made in relation to the primary outcome measure of postprandial glucose from on venous collections. Based previous data from a behavioural intervention (Larsen et al, Clin Sci, 2015) and a chronic (12 wk), meal size intervention (Jakubowicz Obes Silver Spring Md, 2013), we estimated that a sample size of 22 would be required to detect a between treatment difference of 0.9 mmol/L, with a minimum power of 80% and a probability of 0.05 (2-tailed test). This is based on the assumption that the within-patient standard deviation of the response variable is 1.04. As a safeguard and using our experience from previous behavioural interventions, we will over-sample to cover an estimated attrition rate of 15%. Thus, we will aim to recruit 25 participants.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
13/01/2016
Actual
13/01/2016
Date of last participant enrolment
Anticipated
24/10/2016
Actual
19/07/2016
Date of last data collection
Anticipated
Actual
24/08/2016
Sample size
Target
25
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 12141 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 292295 0
Charities/Societies/Foundations
Name [1] 292295 0
Novo-Nordisk Foundation
Country [1] 292295 0
Sweden
Primary sponsor type
Individual
Name
Professor John Hawley
Address
Level 1 Daniel Mannix Building, 8-18 Brunswick St
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Fitzroy, 3065 VIC
Country
Australia
Secondary sponsor category [1] 290980 0
Individual
Name [1] 290980 0
Professor David Dunstan
Address [1] 290980 0
Baker IDI Heart and Diabetes Institute
PO Box 6492, Melbourne
Victoria 3004, Australia
Country [1] 290980 0
Australia
Other collaborator category [1] 278688 0
Individual
Name [1] 278688 0
Dr Evelyn Parr
Address [1] 278688 0
Level 1 Daniel Mannix Building, 8-18 Brunswick St
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Fitzroy 3065 VIC
Country [1] 278688 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293772 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 293772 0
Ethics committee country [1] 293772 0
Australia
Date submitted for ethics approval [1] 293772 0
13/08/2015
Approval date [1] 293772 0
16/12/2015
Ethics approval number [1] 293772 0
2015-209H

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

Contacts
Principal investigator
Name 61234 0
Prof John Hawley
Address 61234 0
Level 1, Daniel Mannix Building
Australian Catholic Universtiy
8-18 Brunwick Street
Fitzroy VIC 3065
Country 61234 0
Australia
Phone 61234 0
+61399533552
Fax 61234 0
Email 61234 0
[email protected]
Contact person for public queries
Name 61235 0
Evelyn Parr
Address 61235 0
Level 1, Daniel Mannix Building
Australian Catholic Universtiy
8-18 Brunwick Street
Fitzroy VIC 3065
Country 61235 0
Australia
Phone 61235 0
+61413477697
Fax 61235 0
Email 61235 0
[email protected]
Contact person for scientific queries
Name 61236 0
John Hawley
Address 61236 0
Level 1, Daniel Mannix Building
Australian Catholic Universtiy
8-18 Brunwick Street
Fitzroy VIC 3065
Country 61236 0
Australia
Phone 61236 0
+61399533552
Fax 61236 0
Email 61236 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

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