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Trial registered on ANZCTR


Registration number
ACTRN12616000840482
Ethics application status
Approved
Date submitted
22/06/2016
Date registered
28/06/2016
Date last updated
17/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of sugar sweetened beverages on glycaemic control during prolonged sitting periods in sedentary overweight and obese adults
Scientific title
Australian Sugary Drink and Sedentary Behaviour Study: The effect of sugar sweetened beverages on glycaemic control during prolonged sitting periods in sedentary overweight and obese adults
Secondary ID [1] 289520 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AusSSB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 299223 0
Cardiovascular Disease 299224 0
Weight Gain 299225 0
High Blood Pressure 299226 0
Condition category
Condition code
Cardiovascular 299233 299233 0 0
Coronary heart disease
Diet and Nutrition 299234 299234 0 0
Obesity
Metabolic and Endocrine 299235 299235 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will assess the impact of Sugar Sweetened Beverages (SSB) on glycaemic control in 29 sedentary, overweight/ obese participants. Each participant will complete two experimental conditions in a randomised, cross-over design at the Baker IDI clinical research suite, Level 4 of the Alfred Centre following a screening and familiarisation visit. The two interventions will be separated by a minimum 21-day wash-out period and will consist of:
(i) 7 hours of uninterrupted sitting together with the consumption of water 90 minutes after a standardised breakfast and lunch meal and
(ii) 7 hours of uninterrupted sitting together with the consumption of a SSB 90 minutes after a standardised breakfast and lunch meal.
Glycaemic control will be measured directly through blood samples and the use of a continuous glucose monitor (CGM) worn for a 22 hour period from the morning of each trial condition until the following morning. Resting blood pressure will be taken every 60 minutes throughout both interventions using an automated blood pressure monitor. Endothelial function will be recorded at baseline (0 time), 3 hours (just prior to lunch) and at 6 hours (just after the final blood sample).

Each participant will rest in a comfortable lounge chair and have access to a television with a DVD player and reading materials such as newspapers and magazines. Participants will be instructed to minimise excessive movement but will be allowed to visit the toilet when necessary. On each testing day, participants will be given a standardised breakfast and lunch meal according to their body mass and height. At -60min a baseline blood sample will be collected and blood pressure and heart rate recorded. After 1-hour of “steady-state”, another baseline blood sample, blood pressure and heart rate measurement will be recorded. A breakfast meal will be provided, commencing the experimental condition thereafter. Lunch will be provided 3 hours after the breakfast meal. Ninety minutes after each meal, (breakfast and lunch) participants will be instructed to consume the SSB or water. Participant will be instructed to drink the same volume of SSB or water within a 10-minute period. The two SSBs consumed (volume of each can- 375mL) after both the breakfast and lunch meals will constitute a total of 728kJ (174 calories) which consists of 42g of sugar (per serve).

To employ a pragmatic approach and assimilate a typical western dietary composition the ’real world’ breakfast and lunch meals will comprise 33% of estimated energy requirements with a macronutrient profile of 53-55% energy from carbohydrate, 12-15% energy from protein and 30-33% energy from fat. Diet will be recorded 24 hours prior to each experimental visit.
Participants will be instructed to refrain from engaging in structured moderate-to-vigorous intensity exercise in the 48 hours before each experimental day. To assess compliance and habitual physical activity, participants will be fitted with two objective activity monitors – an accelerometer (Actigraph model GT3X+) worn on the hip and an inclinometer (activPAL3TM) worn on the thigh for 7 days preceding each experimental condition. Sleep and activities will be recorded for 7 days prior to experimental visit.
Intervention code [1] 295112 0
Lifestyle
Intervention code [2] 295131 0
Prevention
Comparator / control treatment
Participants will sit quietly in a lounge chair and consume water 90 minutes after both the breakfast and lunch meal. Participant will be instructed to drink the same volume of SSB or water within a 10-minute period.
Control group
Active

Outcomes
Primary outcome [1] 298719 0
Post-prandial glycaemic control will be assessed by blood glucose and insulin serum levels.
Timepoint [1] 298719 0
Every 30 minutes from -60 min to 360 min
Secondary outcome [1] 325042 0
Brachial arterial blood pressure will be taken hourly, using an automated oscillometric blood pressure monitor.
Timepoint [1] 325042 0
hourly from -60 min to 360 min
Secondary outcome [2] 325043 0
Endothelial Function will be assessed using an Endo-PAT2000 device – involves measurement of digital pulsatile volume (“Peripheral Arterial Tone” [PAT]) using finger plethysmography.
Timepoint [2] 325043 0
Endo-PAT will be recorded at – 60 min, at 180 min just before the lunch meal and at 360 straight after the final blood collection.
Secondary outcome [3] 325044 0
The number of circulating inflammatory cells and their activation will be measured by FACS (Fluorescence-Activated Cell Sorting) before the first meal (0 min) and 60 min after the last drink (330 min) for analysis of inflammation.
Timepoint [3] 325044 0
Before the first meal (-60 min) and 60 min after the last drink (330min).

Eligibility
Key inclusion criteria
Inclusion Criteria:
1. aged between 19 and 30 years
2. being overweight or obese (BMI greater than or equal to 25 kg/m2 but <40 kg/m2)
3. an habitual consumer of SSBs defined as 2L or more per week for at least the previous 3 months
Minimum age
19 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria:

1. No current use or need for prescription medication that would confound the evaluation and interpretation of the data as decided by the study investigators
2. pregnancy
3. tobacco use within 3 months of Visit 1
4. employment in a non-sedentary occupation (as characterized by low demand for sitting – eg: tradesperson)
5. currently sitting <5hrs per day
6. regularly engaged in moderate-intensity exercise greater than or equal to 150 min/week for >3 months;
7. major illness/physical problems that may limit participation.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13433 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 293895 0
Government body
Name [1] 293895 0
National Health and Medical Research Council
Address [1] 293895 0
National Health and Medical Research Council

GPO Box 1421

Canberra ACT 2601
Country [1] 293895 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart & Diabetes Institute
Address
4th Floor, Alfred Centre
99 Commercial Road
Melbourne VICTORIA 3004
Country
Australia
Secondary sponsor category [1] 292721 0
None
Name [1] 292721 0
Address [1] 292721 0
Country [1] 292721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295313 0
The Alfred Health Human Ethics Committee
Ethics committee address [1] 295313 0
The Alfred
55 Commercial Road
Melbourne VICTORIA 3004
Ethics committee country [1] 295313 0
Australia
Date submitted for ethics approval [1] 295313 0
26/05/2016
Approval date [1] 295313 0
15/06/2016
Ethics approval number [1] 295313 0
201/16

Summary
Brief summary
We propose to assess the impact of Sugar Sweetened Beverages (SSB) on glycaemic control in 29 sedentary, overweight/ obese participants. Each participant will complete two
experimental conditions in a randomised, cross-over design at the Baker IDI clinical research suite, Level 4 of the Alfred Centre, involving (i) 7 hours of uninterupted sitting together with the consumption of water 90 minutes after a standardised breakfast and lunch meal and (ii) 7 hours of uninterupted sitting together with the consumption of a SSB 90 minutes after a standardised breakfast and lunch meal.

Glycaemic control will be measured directly through blood samples every 30 minutes and the use of a continuous glucose monitor (CGM) to collect data for a 22 hour period from the morning of each trial condition until the following morning. Resting blood pressure will be taken every 60 minutes throughout both interventions using an automated blood pressure monitor. Endothelial function will be recorded at baseline (0 time), 3 hours (just prior to lunch) and at 6 hours (just after the final blood sample.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66846 0
Prof Garry Jennings
Address 66846 0
Baker IDI Heart & Diabetes Institute
Level 4, Alfred Centre, 99 Commercial Road, Melbourne
Melbourne VIC 3004
Country 66846 0
Australia
Phone 66846 0
+61 3 8532 1164
Fax 66846 0
Email 66846 0
garry.jennings@bakeridi.edu.au
Contact person for public queries
Name 66847 0
Miss Melissa Formosa
Address 66847 0
Baker IDI Heart & Diabetes Institute
Level 4, Alfred Centre, 99 Commercial Road, Melbourne
Melbourne VIC 3004
Country 66847 0
Australia
Phone 66847 0
+61 3 8532 1656
Fax 66847 0
Email 66847 0
melissa.formosa@bakeridi.edu.au
Contact person for scientific queries
Name 66848 0
Prof Bronwyn Kingwell
Address 66848 0
Baker IDI Heart & Diabetes Institute
Level 4, Alfred Centre, 99 Commercial Road, Melbourne
Melbourne VIC 3004
Country 66848 0
Australia
Phone 66848 0
+61 3 8532 1518
Fax 66848 0
Email 66848 0
bronwyn.kingwell@bakeridi.edu.au

No information has been provided regarding IPD availability
Summary results
No Results