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Trial registered on ANZCTR
Registration number
ACTRN12617001249347
Ethics application status
Approved
Date submitted
23/08/2017
Date registered
28/08/2017
Date last updated
28/08/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Does sucralose, a common artificial sweetener, affect blood pressure and heart rate?
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Scientific title
Effects of the artificial sweetener, sucralose, on blood pressure, heart rate and superior mesenteric artery blood flow compared to intraduodenal glucose infusion in healthy older subjects
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Secondary ID [1]
292676
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postprandial hypotension
304425
0
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Condition category
Condition code
Diet and Nutrition
303754
303754
0
0
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Other diet and nutrition disorders
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Metabolic and Endocrine
303755
303755
0
0
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Diabetes
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Cardiovascular
303820
303820
0
0
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Normal development and function of the cardiovascular system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Subjects will attend on three separate occasions (after fasting from solids for 14 h and liquids for 12 h) at least five days apart.
Subjects will receive an ID (intraduodenal) infusion of each of the following on the three study days:
(1) 25 %w/v glucose at a rate of 3 kcal/min,
(2) 4 mM sucralose in 0.9 %w/v saline, or
(3) 0.9 %w/v saline
All in a volume of 300 mL over 60 minutes (i.e. 5mL/min from t = 0 – 60 min). Saline (0.9%w/v) will be infused at a rate of 5mL/min for a further 60min (i.e. t = 60 – 120min).
On each study day, subjects will undergo measurements of blood pressure (BP), heart rate (HR) and superior mesenteric artery (SMA) blood flow by Doppler ultrasonography, cardiac output (CO), stroke volume (SV), blood glucose, serum insulin, plasma glucagon-like peptide 1 (GLP-1), gastric inhibitory polypeptide (GIP) and catecholamines under randomised, double-blind conditions. Each study will be separated by at least 5 days.
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Intervention code [1]
298915
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Treatment: Other
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Comparator / control treatment
A total of 12 healthy subjects that passed the screening test underwent all three conditions, in a randomised fashion. The effects of sucralose on blood pressure, heart rate and superior mesenteric artery flow were compared to glucose and saline (control),
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Control group
Placebo
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Outcomes
Primary outcome [1]
303127
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Blood pressure using automated BP cuff (DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA).
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Assessment method [1]
303127
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Timepoint [1]
303127
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Blood pressure was measured at 3 min intervals for 9 min prior to ID infusion, and then every 3 mins for duration of ID infusion (t = 0 - 120 min).
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Primary outcome [2]
303179
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Heart rate using automated BP cuff (DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA).
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Assessment method [2]
303179
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Timepoint [2]
303179
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Heart rate was measured at 3 min intervals for 9 min prior to ID infusion, and then every 3 mins for duration of ID infusion (t = 0 - 120 min).
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Secondary outcome [1]
337990
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SMA blood flow using a Logiq GE doppler ultrasonography system (GE Healthcare Technologies, Sydney, NSW, Australia).
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Assessment method [1]
337990
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Timepoint [1]
337990
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SMA blood flow was measured prior to ID infusion (t=-3), and then every 15 mins for duration of ID infusion (t = 0 - 120 min).
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Secondary outcome [2]
338150
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Blood glucose using a portable blood glucose meter (MediSense Companion 2 meter; MediSense Inc., Waltham, MA)
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Assessment method [2]
338150
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Timepoint [2]
338150
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Blood glucose was measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,
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Secondary outcome [3]
338159
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Cardiac output using the Finometer Pro (Finapres Medical Systems)
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Assessment method [3]
338159
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Timepoint [3]
338159
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Cardiac output was measured at 3 min intervals for 9 min prior to ID infusion, and then every 3 mins for duration of ID infusion (t = 0 - 120 min).
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Secondary outcome [4]
338160
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Stroke volume using the Finometer Pro (Finapres Medical Systems)
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Assessment method [4]
338160
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Timepoint [4]
338160
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Stroke volume was measured at 3 min intervals for 9 min prior to ID infusion, and then every 3 mins for duration of ID infusion (t = 0 - 120 min).
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Secondary outcome [5]
338161
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Insulin using plasma samples
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Assessment method [5]
338161
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Timepoint [5]
338161
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Insulin was measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,
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Secondary outcome [6]
338162
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Glucagon-like peptide 1 (GLP-1) using plasma samples
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Assessment method [6]
338162
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Timepoint [6]
338162
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GLP-1 was measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,
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Secondary outcome [7]
338163
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Gastric inhibitory polypeptide (GIP) using plasma samples
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Assessment method [7]
338163
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Timepoint [7]
338163
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GIP was measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,
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Secondary outcome [8]
338164
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Catecholamines using plasma samples
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Assessment method [8]
338164
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Timepoint [8]
338164
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Catecholamines were measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,
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Eligibility
Key inclusion criteria
• Healthy subjects
• Male or female subjects aged 65–80 years
• Body Mass Index 19-30 kg/m²
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Minimum age
65
Years
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Maximum age
80
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
• History of diabetes mellitus (or fasting plasma glucose >7.0 mmol/L), severe respiratory, cardiovascular, hepatic and/or renal disease (creatinine clearance <50 mL/min), chronic alcohol abuse or epilepsy or if iron stores, or liver function tests are outside the following ranges:
Alanine aminotransferase (ALT) < 55 U/L
Alkaline phosphatase (ALP) 30 - 110 U/L
Aspartate transaminase (AST) < 45 U/L
Total bilirubin 2 - 24 µmol/L
Haemoglobin 115 – 165 g/L (Females)
130 – 180 g/L (Males)
Ferritin 15 – 200 µg/L (Females)
30 – 300 µg/L (Males)
• Medication that influence BP or GI function
• History of GI disease, including known gastroparesis, significant upper GI symptoms and gastric surgery
• Smoking >10 cigarettes/day
• Alcohol consumption > 20 g/day
• Severe nasal septum deviation
• Blood donation in the previous 12 week
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Study design
Purpose of the study
Treatment
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data will be analysed using standardised, non-parametric statistical methods (e.g. using repeated measures ANOVA). Relationships between variables will be assessed by linear regression analysis.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
13/06/2016
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Date of last participant enrolment
Anticipated
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Actual
30/11/2016
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Date of last data collection
Anticipated
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Actual
20/12/2016
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Sample size
Target
12
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
8827
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
16953
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
297316
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Hospital
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Name [1]
297316
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Royal Adelaide Hospital Clinical Project Grant
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Address [1]
297316
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North Terrace, Adelaide SA 5000
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Country [1]
297316
0
Australia
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Primary sponsor type
Individual
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Name
Professor Karen Jones
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Address
NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide,
Level 5 Adelaide Health and Medical Sciences Building, Cnr North Tce and George St, Adelaide, SA 5005
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Country
Australia
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Secondary sponsor category [1]
296295
0
None
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Name [1]
296295
0
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Address [1]
296295
0
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Country [1]
296295
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298419
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Royal Adelaide Hospital
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Ethics committee address [1]
298419
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North Terrace, Adelaide SA 5000
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Ethics committee country [1]
298419
0
Australia
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Date submitted for ethics approval [1]
298419
0
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Approval date [1]
298419
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24/02/2016
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Ethics approval number [1]
298419
0
R20160218
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Summary
Brief summary
This study is designed to evaluate the effects of the artificial sweetener, sucralose, compared to glucose and saline (control), on blood pressure, heart rate and superior mesenteric artery flow following intraduodenal infusion, in healthy older subjects.
On three separate days, separated by at least 5 days, subjects will receive an ID infusion of either (1) 25 %w/v glucose at a rate of 3 kcal/min, (2) 4 mM sucralose in 0.9 %w/v saline, or (3) 0.9 %w/v saline all in a volume of 300 mL over 60 minutes (i.e. 5mL/min from t = 0 – 60 min). Saline (0.9%w/v) will be infused at a rate of 5mL/min for a further 60min (i.e. t = 60 – 120min). Measurements of blood pressure (BP), heart rate (HR) and superior mesenteric artery (SMA) blood flow by Doppler ultrasonography, cardiac output (CO), stroke volume (SV), blood glucose, serum insulin, plasma glucagon-like peptide 1 (GLP-1), gastric inhibitory polypeptide (GIP) and catecholamines under randomised, double-blind conditions.
The primary hypotheses underlying the current study are that (i) compared to saline, intraduodenal infusions of glucose and sucralose will induce a larger reduction in blood pressure and increases in both heart rate and superior mesenteric artery flow and (ii) ID glucose will have a greater hypotensive response than sucralose.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
1977
1977
0
0
/AnzctrAttachments/373492-Sucralose Protocol_v2 Final.pdf
(Protocol)
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Attachments [2]
1978
1978
0
0
/AnzctrAttachments/373492-Participant information and consent form.pdf
(Participant information/consent)
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Attachments [3]
1992
1992
0
0
/AnzctrAttachments/373492-R20160218 Jones K - LNR Approval Letter_signed.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
77026
0
Prof Karen Jones
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Address
77026
0
NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide,
Level 5 Adelaide Health and Medical Sciences Building, Cnr North Tce and George St, Adelaide, SA 5005, Australia
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Country
77026
0
Australia
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Phone
77026
0
+61-8-8313 7821
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Fax
77026
0
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Email
77026
0
[email protected]
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Contact person for public queries
Name
77027
0
Prof Karen Jones
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Address
77027
0
NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health
The University of Adelaide,
Level 5 Adelaide Health and Medical Sciences Building
Cnr North Tce and George St
Adelaide SA 5005 Australia
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Country
77027
0
Australia
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Phone
77027
0
+61-8-8313 7821
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Fax
77027
0
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Email
77027
0
[email protected]
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Contact person for scientific queries
Name
77028
0
Prof Karen Jones
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Address
77028
0
NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health
The University of Adelaide,
Level 5 Adelaide Health and Medical Sciences Building
Cnr North Tce and George St
Adelaide SA 5005 Australia
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Country
77028
0
Australia
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Phone
77028
0
+61-8-8313 7821
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Fax
77028
0
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Email
77028
0
[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
Effects of intraduodenal administration of the artificial sweetener sucralose on blood pressure and superior mesenteric artery blood flow in healthy older subjects.
2018
https://dx.doi.org/10.1093/ajcn/nqy060
N.B. These documents automatically identified may not have been verified by the study sponsor.
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