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Trial registered on ANZCTR


Registration number
ACTRN12619000438156
Ethics application status
Approved
Date submitted
18/02/2019
Date registered
18/03/2019
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a preload containing whey protein and guar (Omniblend) reduce the fall in blood pressure and affect the rate of stomach emptying after a sugary drink?
Scientific title
Effects of a guar and whey containing preload (Omniblend) on gastric emptying and blood pressure responses to oral glucose in healthy older subjects
Secondary ID [1] 294856 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial hypotension 307801 0
Condition category
Condition code
Cardiovascular 306849 306849 0 0
Other cardiovascular diseases
Metabolic and Endocrine 306850 306850 0 0
Diabetes
Diet and Nutrition 306851 306851 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will participate in two separate occasions at least five days apart after fasting from solids for 14 h and liquids for 12 h. Subjects will receive a phone call the day before the study to remind them of the requirement to fast and this will also be queried on the morning of the study.
After a rest-period of 15-30 minutes to allow baseline BP to settle, subjects will be given: in random order, either:
(i) a test drink containing 50 g glucose labelled with 20 MBq 99mTc-calcium phytate, made up to 300ml water
(ii) a preload containing 20g whey protein and 5g guar (Omniblend) made up to 150ml with water 15 minutes before the ingestion of the test drink.

Subjects will undergo concurrent measurements of gastrointestinal (GI) symptoms (questionnaire), gastric emptying (scintigraphy), blood pressure, heart rate (DINAMAP), superior mesenteric artery blood flow (Doppler ultrasound), blood glucose, serum insulin, plasma Glucagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide (GIP) and glucose absorption (utilising 3-OMG).
Intervention code [1] 301165 0
Treatment: Other
Comparator / control treatment
The test drink containing 50 g glucose labelled with 20 MBq 99mTc-calcium phytate, made up to 300ml water serves as the control for each subject
Control group
Active

Outcomes
Primary outcome [1] 305840 0
Blood pressure (BP) using automated BP cuff (DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA).
Timepoint [1] 305840 0
BP will be measured at 3 min intervals prior to administration of test drink, and then regularly at 5 min intervals from t = 5 - 180 min
Primary outcome [2] 305841 0
Heart rate (HR) using automated BP cuff (DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA).
Timepoint [2] 305841 0
HR will be measured at 3 min intervals prior to administration of test drink, and then regularly at 5 min intervals from t = 5 - 180 min
Primary outcome [3] 305842 0
Gastric emptying assessed by Scintigraphy
Timepoint [3] 305842 0
Dynamic scintigraphic images will be acquired at 1 minute per frame for the first hour and at 3 minutes per frame for another two hours
Secondary outcome [1] 346766 0
Superior mesenteric artery (SMA) blood flow assessed by Doppler ultrasonography using a Logiq 9 ultrasound system (GE Medical Systems)
Timepoint [1] 346766 0
SMA blood flow will be measured immediately prior to administration of the preload (t = -18 min) and/or test drink (t= -2 minutes) and then at t = 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Secondary outcome [2] 346767 0
Blood glucose measured with a portable glucometer on blood samples collected from an IV cannula
Timepoint [2] 346767 0
Blood glucose will be measured prior to the ingestion of the preload (t = -18 minutes) and/or test drink (t= -2 minutes) and then at t = 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary outcome [3] 346768 0
Insulin using serum samples
Timepoint [3] 346768 0
Insulin will be measured prior to the ingestion of the preload (t = -18 minutes) and/or test drink (t= -2 minutes) and then at t = 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary outcome [4] 346769 0
Glucose absorption using 3-OMG
Timepoint [4] 346769 0
Glucose absorption will be measured prior to the ingestion of the preload (t = -18 minutes) and/or test drink (t= -2 minutes) and then at t = 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary outcome [5] 346770 0
Glucagon-like peptide 1 (GLP-1) using plasma samples
Timepoint [5] 346770 0
GLP-1 will be measured prior to the ingestion of the preload (t = -18 minutes) and/or test drink (t= -2 minutes) and then at t = 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary outcome [6] 346771 0
Gastric inhibitory polypeptide (GIP) using plasma samples
Timepoint [6] 346771 0
GIP will be measured prior to the ingestion of the preload (t = -18 minutes) and/or test drink (t= -2 minutes) and then at t = 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary outcome [7] 346772 0
Sensations of appetite measured with a visual analogue scale
Timepoint [7] 346772 0
A visual analogue scale (VAS) will be given immediately prior to the ingestion of the preload (t = -18 minutes) and/or test drink (t= -2 minutes) then at t = 15, 30, 45, 60, 90, 120, 150 and 180 minutes

Eligibility
Key inclusion criteria
• Healthy subjects
• 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 or HbA1C =6.5%)
• Severe respiratory or cardiovascular disease which would limit tolerance of study
• Hepatic disease as defined by transaminases more than 2 x upper limit of normal or bilirubin more than 2 X upper limit of normal
• Renal disease (creatinine clearance less than 50 mL/min)
• Anaemia or iron deficiency

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
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
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)
SA
Recruitment hospital [1] 10879 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 22637 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 299444 0
Commercial sector/Industry
Name [1] 299444 0
Omniblend Innovation Pty Ltd
Address [1] 299444 0
Level 17, 31 Queen St, Melbourne VIC 3000
Country [1] 299444 0
Australia
Primary sponsor type
Individual
Name
Professor Karen Jones
Address
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] 298739 0
None
Name [1] 298739 0
Address [1] 298739 0
Country [1] 298739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300348 0
CALHN Human Research Ethics Committee
Ethics committee address [1] 300348 0
Level 3, Roma Mitchell House
136 North Terrace
Adelaide, South Australia, 5000
Ethics committee country [1] 300348 0
Australia
Date submitted for ethics approval [1] 300348 0
09/03/2018
Approval date [1] 300348 0
03/05/2018
Ethics approval number [1] 300348 0
R20180318

Summary
Brief summary
Postprandial hypotension (PPH) is defined as a larger than expected fall in blood pressure following a meal – the more exact definition is a fall in blood pressure of greater than 20mmHg for a period lasting longer than 30 minutes, following a meal. PPH may lead to fainting and is common in older people.

In this study, we are interested in seeing whether a preload containing whey protein and guar (Omniblend) can reduce the fall in blood pressure after a sugary drink – and also whether the rate of stomach emptying is affected by this preload.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2685 2685 0 0
Attachments [2] 2686 2686 0 0
/AnzctrAttachments/375076-Omniblend-Information sheet v2.pdf (Participant information/consent)
Attachments [3] 2687 2687 0 0

Contacts
Principal investigator
Name 83362 0
Prof Karen Jones
Address 83362 0
The University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building
Cnr North Tce and George St
Adelaide, SA 5005
Country 83362 0
Australia
Phone 83362 0
+61-8-8313 7821
Fax 83362 0
Email 83362 0
karen.jones@adelaide.edu.au
Contact person for public queries
Name 83363 0
Prof Karen Jones
Address 83363 0
The University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building
Cnr North Tce and George St
Adelaide, SA 5005
Country 83363 0
Australia
Phone 83363 0
+61-8-8313 7821
Fax 83363 0
Email 83363 0
karen.jones@adelaide.edu.au
Contact person for scientific queries
Name 83364 0
Prof Karen Jones
Address 83364 0
The University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building
Cnr North Tce and George St
Adelaide, SA 5005
Country 83364 0
Australia
Phone 83364 0
+61-8-8313 7821
Fax 83364 0
Email 83364 0
karen.jones@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data are confidential and no consent has been given from enrolled participants
What supporting documents are/will be available?
No other documents available
Summary results
No Results