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Trial registered on ANZCTR


Registration number
ACTRN12623000029695
Ethics application status
Approved
Date submitted
14/12/2022
Date registered
12/01/2023
Date last updated
21/01/2024
Date data sharing statement initially provided
12/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of quinine, alone and combined with dietary nutrients before a highly palatable milkshake, on gut function and blood glucose in healthy volunteers
Scientific title
Effects of quinine, alone and combined with dietary nutrients before a highly palatable milkshake, on gut function and blood glucose in healthy volunteers
Secondary ID [1] 308266 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
increased energy intake 328049 0
Condition category
Condition code
Metabolic and Endocrine 325106 325106 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive in randomised, double-blind fashion, a 10-ml bolus of either(i) 600 mg quinine (ii) 300 mg quinine, (iii) water (control) intraduodenally on 3 separate visits. Each visit will be ~5 hours in duration and separated by 3-7 days. In females, the study visits will be arranged in the 7-10 days from the start of their period cycle. Studies will be performed at the Clinical Research Facility, Adelaide Medical School, University of Adelaide, by staff and students trained in the required clinical research techniques.

Participants will consume a standardised dinner meal, (400g McCain's beef lasagne), the night before each study visit by no later than 7pm. After fasting for ~13.5 hours overnight and refraining from alcohol and exercise for 24 hours, participants will arrive at the Clinical Research Facility by 8:15 am. Upon arrival, participants will be given a standardised light breakfast (1 slice (30 g) white bread, 10 g jam and a cup (200 ml) black tea; ~100 kcal), after which they will be intubated with a 17-channel manometric catheter (Dentsleeve, Mui Scientific) that will be inserted through an anaesthetised nostril and allowed to pass through the stomach and into the duodenum by peristalsis. The infusion port will be positioned ~ 14 cm distal to the pylorus. The correct positioning of the catheter will be monitored continuously by measurement of the transmucosal potential difference in the stomach (~ -40 mV) and the duodenum (~ 0 mV). Once the catheter has been positioned correctly, an intravenous cannula will be placed into a forearm vein for regular blood sampling. At 11.30 am, t = -30 min, a baseline blood sample (10 ml) will be taken, the participant will complete a validated 100-ml visual analogue scale (VAS) questionnaire, to assess appetite-related perceptions and gastrointestinal (GI) symptoms as well as the Leeds Food Preference Questionnaire, which is a computerised behavioural task that provides measures of 'liking' and 'wanting' components of food preference and food reward. Immediately thereafter (t = -30 min), participants will receive either (i) 600 mg quinine, (ii) 300 mg quinine, (iii) water into the duodenum. 10-ml blood samples for the measurement of plasma concentrations of hormones and glucose will be collected every 10 min (-20, -10, 0), and participants complete VAS questionnaires. Participants will complete Leeds Food Preference Questionnaire once immediately before quinine administration (t=-30) and once 30 minutes later, immediately before the milkshake (t=-1). In each visit, participants will be provided with a highly palatable milkshake at irregular intervals and varying volumes. The milkshake comprises of vanilla ice cream (Golden North), 2% milk (Devondale) and chocolate topping (Hershey’s) containing approximately 128kcal/100mL. A maximum of 1 L will be offered to the participants for each study. Immediately after 30 minutes, and then every 30 min (t = 60 and 90 min), blood samples will be collected and participants complete VAS questionnaires. At t = 90 min, the intravenous cannula will be removed, and participants will be allowed to leave the laboratory.
Intervention code [1] 324819 0
Treatment: Other
Comparator / control treatment
Water
Control group
Placebo

Outcomes
Primary outcome [1] 333055 0
Energy intake from palatable milkshake will be measured using the computer software program FoodWorks.
Timepoint [1] 333055 0
A palatable milkshake will be presented during each study visit (t = 0-30 min). The cups will be refilled at irregular intervals e.g., t=0, 2, 5, 9, 14, 19, 24.
Secondary outcome [1] 415651 0
Plasma concentrations of cholecystokinin, other gastrointestinal hormones e.g., peptide yy (PYY), ghrelin and blood glucose will be measured. This outcome is of an exploratory nature so that the specific parameters to be measured may be decided upon based on the effect of the intervention on this and other outcomes, therefore, this is a composite outcome.
Timepoint [1] 415651 0
Plasma gut hormone concentration and blood glucose levels will be assessed from blood samples taken at t= -30, -20, -10, 0, 30, 60, and 90 min, where t = -30 is just prior to the time of quinine administration and t = 0 is immediately before milkshake.
Secondary outcome [2] 417337 0
Hunger will be measured using VAS questionnaire.
Timepoint [2] 417337 0
VAS questionnaires will be completed at t = -31, -20, -10, 0, 30, 60 and 90 min, where t = -30 is just prior to the time of quinine administration and t = 0 is immediately before milkshake.
Secondary outcome [3] 417338 0
Fullness will be measured using VAS questionnaires.
Timepoint [3] 417338 0
VAS questionnaires will be completed at t = -31, -20, -10, 0, 30, 60 and 90 min, where t = -30 is just prior to the time of quinine administration and t = 0 is immediately before milkshake.
Secondary outcome [4] 417339 0
Desire to eat will be measured using VAS questionnaires.
Timepoint [4] 417339 0
VAS questionnaires will be completed at t = -31, -20, -10, 0, 30, 60 and 90 min, where t = -30 is just prior to the time of quinine administration and t = 0 is immediately before milkshake.
Secondary outcome [5] 417340 0
Amount of food desired to eat measured using VAS questionnaires.
Timepoint [5] 417340 0
VAS questionnaires will be completed at t = -31, -20, -10, 0, 30, 60 and 90 min, where t = -30 is just prior to the time of quinine administration and t = 0 is immediately before milkshake.
Secondary outcome [6] 417341 0
The 'liking' and 'wanting' components of food preference and food reward will be measured using the Leeds Food Preference Questionnaire. This is a composite secondary outcome.
Timepoint [6] 417341 0
The 'liking' and 'wanting' components of food preference and food reward will be measured once immediately before treatment administration (t=-30) and once 30 minutes later, immediately before milkshake (t=-1).

Eligibility
Key inclusion criteria
Healthy
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-regular gastrointestinal symptoms or significant gastrointestinal disease
-previous gastrointestinal surgery (other than gallbladder removal)
-use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal function, body weight or appetite (e.g. domperidone, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
-substantial daily consumption of quinine, e.g. as part of quinine-based anti-malaria treatment (irregular consumption of small amounts of quinine, e.g. in tonic water, is acceptable)
-regular medication that may affect any of the study outcomes (i.e. gastrointestinal motor or hormone function) and cannot be discontinued during the study
-using contraceptive pills, injections, IUD
-other food allergy
-current gallbladder or pancreatic disease
-coagulation abnormalities
-oesophageal varices or strictures
-cardiovascular or respiratory diseases that may affect any of the study outcomes and/or tolerance of the naso-duodenal tube
-all types of epilepsy
-individuals with low ferritin levels (females <15 ng/mL, males <30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
-any other illnesses as assessed by the investigator (including chronic illnesses that may affect any of the study outcomes and not explicitly listed above)
-high performance athletes, due to their specific dietary requirements and energy intakes (i.e. much higher than the average population), which affect gastrointestinal functions
-current intake of > 2 standard alcoholic drinks on > 5 days per week, due to the known effects of alcohol on gastrointestinal function
-current smokers/users of tobacco products (including pipe, chewing, cigarettes, cigars, sheesha, vaping)
-recreational drug use (e.g. marijuana)
-current intake of any illicit substance (since all of these, i.e. tobacco products, marijuana and illicit drugs may affect gastrointestinal functions)
-vegetarians
-inability to tolerate naso-gastric tube
-inability to comprehend study protocol
-in premenopausal females, pregnancy, lactation or surgical sterilisation (a pregnancy test will be performed, using a urine sample, on the morning of study day
-female participants with self-reported irregular period cycles, (since studies will be performed during the follicular phase, to avoid any influences of the different stages of the menstrual cycle on study outcomes)

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)
Eligible volunteers are assigned a participant number and randomised treatment for each study visit. Randomisation involves contacting the holder (study assistant) of the allocation schedule to inform her of participant details and study dates. The unblinded study assistant will be, therefore, responsible for allocating a random treatment to the participant and making and administrating that on the study days.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation is generated using sealedenvelope.com
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
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2023
Actual
30/01/2023
Date of last participant enrolment
Anticipated
17/06/2024
Actual
Date of last data collection
Anticipated
26/07/2024
Actual
Sample size
Target
24
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312519 0
Government body
Name [1] 312519 0
National Health and Medical Research Council (NHMRC)
Country [1] 312519 0
Australia
Primary sponsor type
Individual
Name
Professor Christine Feinle-Bisset
Address
Adelaide Medical School
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce,
Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 314109 0
Individual
Name [1] 314109 0
Professor Michael Horowitz
Address [1] 314109 0
Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Country [1] 314109 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311852 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 311852 0
Ethics committee country [1] 311852 0
Australia
Date submitted for ethics approval [1] 311852 0
12/11/2020
Approval date [1] 311852 0
26/11/2020
Ethics approval number [1] 311852 0
CALHN Protocol No. R20161005 HREC/16/RAH/410

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122602 0
Prof Christine Feinle-Bisset
Address 122602 0
Discipline of Medicine University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Country 122602 0
Australia
Phone 122602 0
+61 8 8313 6053
Fax 122602 0
Email 122602 0
christine.feinle@adelaide.edu.au
Contact person for public queries
Name 122603 0
Christine Feinle-Bisset
Address 122603 0
Discipline of Medicine University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Country 122603 0
Australia
Phone 122603 0
+61 8 8313 6053
Fax 122603 0
Email 122603 0
christine.feinle@adelaide.edu.au
Contact person for scientific queries
Name 122604 0
Christine Feinle-Bisset
Address 122604 0
Discipline of Medicine University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Country 122604 0
Australia
Phone 122604 0
+61 8 8313 6053
Fax 122604 0
Email 122604 0
christine.feinle@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
The datasets generated during and/or analysed during the current study are not publicly available due to the ethical statement and informed consent that require privacy of data.


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
No additional documents have been identified.