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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?
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
Secondary ID [1] 292676 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial hypotension 304425 0
Condition category
Condition code
Diet and Nutrition 303754 303754 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 303755 303755 0 0
Diabetes
Cardiovascular 303820 303820 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 298915 0
Treatment: Other
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),
Control group
Placebo

Outcomes
Primary outcome [1] 303127 0
Blood pressure using automated BP cuff (DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA).
Timepoint [1] 303127 0
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).
Primary outcome [2] 303179 0
Heart rate using automated BP cuff (DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA).
Timepoint [2] 303179 0
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).
Secondary outcome [1] 337990 0
SMA blood flow using a Logiq GE doppler ultrasonography system (GE Healthcare Technologies, Sydney, NSW, Australia).
Timepoint [1] 337990 0
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).
Secondary outcome [2] 338150 0
Blood glucose using a portable blood glucose meter (MediSense Companion 2 meter; MediSense Inc., Waltham, MA)
Timepoint [2] 338150 0
Blood glucose was measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,
Secondary outcome [3] 338159 0
Cardiac output using the Finometer Pro (Finapres Medical Systems)
Timepoint [3] 338159 0
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).
Secondary outcome [4] 338160 0
Stroke volume using the Finometer Pro (Finapres Medical Systems)
Timepoint [4] 338160 0
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).
Secondary outcome [5] 338161 0
Insulin using plasma samples
Timepoint [5] 338161 0
Insulin was measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,
Secondary outcome [6] 338162 0
Glucagon-like peptide 1 (GLP-1) using plasma samples
Timepoint [6] 338162 0
GLP-1 was measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,
Secondary outcome [7] 338163 0
Gastric inhibitory polypeptide (GIP) using plasma samples
Timepoint [7] 338163 0
GIP was measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,
Secondary outcome [8] 338164 0
Catecholamines using plasma samples
Timepoint [8] 338164 0
Catecholamines were measured prior to ID infusion (t=-3), and then at t = 15, 30, 45, 60, 90, 120,

Eligibility
Key inclusion criteria
• Healthy subjects
• Male or female subjects aged 65–80 years
• Body Mass Index 19-30 kg/m²
Minimum age
65 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Completed
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)
SA
Recruitment hospital [1] 8827 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 16953 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 297316 0
Hospital
Name [1] 297316 0
Royal Adelaide Hospital Clinical Project Grant
Address [1] 297316 0
North Terrace, Adelaide SA 5000
Country [1] 297316 0
Australia
Primary sponsor type
Individual
Name
Professor Karen Jones
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
Country
Australia
Secondary sponsor category [1] 296295 0
None
Name [1] 296295 0
Address [1] 296295 0
Country [1] 296295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298419 0
Royal Adelaide Hospital
Ethics committee address [1] 298419 0
North Terrace, Adelaide SA 5000
Ethics committee country [1] 298419 0
Australia
Date submitted for ethics approval [1] 298419 0
Approval date [1] 298419 0
24/02/2016
Ethics approval number [1] 298419 0
R20160218

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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1977 1977 0 0
Attachments [2] 1978 1978 0 0
/AnzctrAttachments/373492-Participant information and consent form.pdf (Participant information/consent)
Attachments [3] 1992 1992 0 0

Contacts
Principal investigator
Name 77026 0
Prof Karen Jones
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
Country 77026 0
Australia
Phone 77026 0
+61-8-8313 7821
Fax 77026 0
Email 77026 0
karen.jones@adelaide.edu.au
Contact person for public queries
Name 77027 0
Prof Karen Jones
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
Country 77027 0
Australia
Phone 77027 0
+61-8-8313 7821
Fax 77027 0
Email 77027 0
karen.jones@adelaide.edu.au
Contact person for scientific queries
Name 77028 0
Prof Karen Jones
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
Country 77028 0
Australia
Phone 77028 0
+61-8-8313 7821
Fax 77028 0
Email 77028 0
karen.jones@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary