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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
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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
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Secondary ID [1]
289520
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
AusSSB
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Cardiovascular Disease
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Weight Gain
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High Blood Pressure
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Condition category
Condition code
Cardiovascular
299233
299233
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0
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Coronary heart disease
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Diet and Nutrition
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299234
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0
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Obesity
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Metabolic and Endocrine
299235
299235
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
295112
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Lifestyle
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Intervention code [2]
295131
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Post-prandial glycaemic control will be assessed by blood glucose and insulin serum levels.
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Assessment method [1]
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Timepoint [1]
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Every 30 minutes from -60 min to 360 min
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Secondary outcome [1]
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Brachial arterial blood pressure will be taken hourly, using an automated oscillometric blood pressure monitor.
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Assessment method [1]
325042
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Timepoint [1]
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hourly from -60 min to 360 min
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Secondary outcome [2]
325043
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Endothelial Function will be assessed using an Endo-PAT2000 device – involves measurement of digital pulsatile volume (“Peripheral Arterial Tone” [PAT]) using finger plethysmography.
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Assessment method [2]
325043
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Timepoint [2]
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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.
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Secondary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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Before the first meal (-60 min) and 60 min after the last drink (330min).
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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
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Minimum age
19
Years
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Maximum age
30
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
4/07/2016
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
29
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
13433
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Baker IDI Heart & Diabetes Institute
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Address
4th Floor, Alfred Centre
99 Commercial Road
Melbourne VICTORIA 3004
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
292721
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Country [1]
292721
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295313
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The Alfred Health Human Ethics Committee
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Ethics committee address [1]
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The Alfred 55 Commercial Road Melbourne VICTORIA 3004
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/05/2016
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Approval date [1]
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15/06/2016
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Ethics approval number [1]
295313
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201/16
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Garry Jennings
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Address
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Baker IDI Heart & Diabetes Institute
Level 4, Alfred Centre, 99 Commercial Road, Melbourne
Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 8532 1164
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Melissa Formosa
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Address
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Baker IDI Heart & Diabetes Institute
Level 4, Alfred Centre, 99 Commercial Road, Melbourne
Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 8532 1656
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Bronwyn Kingwell
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Address
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Baker IDI Heart & Diabetes Institute
Level 4, Alfred Centre, 99 Commercial Road, Melbourne
Melbourne VIC 3004
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Country
66848
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Australia
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Phone
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+61 3 8532 1518
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Fax
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Between-meal sucrose-sweetened beverage consumption impairs glycaemia and lipid metabolism during prolonged sitting: A randomized controlled trial.
2019
https://dx.doi.org/10.1016/j.clnu.2018.08.021
N.B. These documents automatically identified may not have been verified by the study sponsor.
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