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Trial registered on ANZCTR

Registration number

ACTRN12618000814279

Ethics application status

Approved

Date submitted

10/05/2018

Date registered

11/05/2018

Date last updated

20/08/2019

Date data sharing statement initially provided

20/08/2019

Date results provided

20/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of intragastric administration of quinine (bitter agonist), on appetite and gut hormone release in healthy, lean volunteers.

Scientific title

Effects of intragastric administration of quinine (bitter agonist), on appetite and energy intake, and gut hormone release, in healthy, lean volunteers.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Type 2 Diabetes

Healthy human gastrointestinal physiology

Condition category

Condition code

Diet and Nutrition

Obesity

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This trial aims to assess the effects of an intragastric administration of quinine on appetite and energy intake.

In this study, subjects will receive, in randomized, double-blind fashion, an intragastric bolus infusion (21 mL) of i) 275 mg quinine; ii) 600 mg quinine and iii) saline (control) followed 30 min later by an ad libitum buffet style meal. Subjects will receive one infusion per study visit. Study visits will be separated by 3-7 days.

For each study visit a baseline blood sample, and Visual analogue Scale (VAS) questionnaire will be collected (t = -31) . The infusion will then be administered using a feeding tube, at the end of which will be marked as t=-30. At t = -20, -10, and 0 min, a further blood sample will be collected and VAS completed. At t = 0 min, subjects will be presented with a cold, buffet-style meal. Subjects will be allowed 30 minutes to freely consume the buffet meal until comfortably full. At t = 30, 60 and 90 min further blood samples will be taken, and VAS administered at t = 30, 45 60, 75 and 90 min,

Intervention code [1]

Treatment: Other

Comparator / control treatment

Saline control for within group comparison.

Control group

Placebo

Outcomes

Primary outcome [1]

Energy intake at the buffet meal measured using the computer software program FoodWorks.

Timepoint [1]

A buffet meal will be presented during each study visit (t = 0-30). The subject will be allowed to freely consume food until comfortably full for 30 minutes.

Secondary outcome [1]

Plasma concentrations of cholecystokinin, and other gastrointestinal hormones (e.g. PYY, ghrelin), This outcome is of an exploratory nature so that other gastrointestinal hormones to be measured may be decided upon based on the effect of the intervention on this and other outcomes.

Timepoint [1]

Gut hormone release will be assessed from blood samples taken at t = -31, -20, -10, 0, 30, 60 and 90 min, where t = -31 is just prior to the time of quinine administration and t = 0 is the start of the buffet meal.

Secondary outcome [2]

Measure satiety sensation using a VAS questionnaire.

Timepoint [2]

Satiety will be measured at t = -31, -20, -10, 0, 30, 45, 60, 75 and 90 min, where t = -31 is just prior to the time of quinine administration and t = 0 is the start of the buffet meal.

Secondary outcome [3]

Measure hunger sensation using a VAS questionnaire.

Timepoint [3]

Hunger will be measured at t = -31, -20, -10, 0, 30, 45, 60, 75 and 90 min, where t = -31 is just prior to the time of quinine administration and t = 0 is the start of the buffet meal.

Secondary outcome [4]

Measure fullness sensation using a VAS questionnaire.

Timepoint [4]

Fullness will be measured at t = -31, -20, -10, 0, 30, 45, 60, 75 and 90 min, where t = -31 is just prior to the time of quinine administration and t = 0 is the start of the buffet meal.

Secondary outcome [5]

Measure the desire to eat using a VAS questionnaire.

Timepoint [5]

The desire to eat will be measured at t = -31, -20, -10, 0, 30, 45, 60, 75 and 90 min, where t = -31 is just prior to the time of quinine administration and t = 0 is the start of the buffet meal.

Secondary outcome [6]

Measure the amount of food the subject thinks he/she could eat using a VAS questionnaire.

Timepoint [6]

The amount of food the subject thinks he/she could eat will be measured at t = -31, -20, -10, 0, 30, 45, 60, 75 and 90 min, where t = -31 is just prior to the time of quinine administration and t = 0 is the start of the buffet meal.

Eligibility

Key inclusion criteria

A total of 12 healthy, lean (BMI 19-25 kg/m2) male subjects, aged between 18 - 55 years, will be included in each study part.

Minimum age

18 Years

Maximum age

55 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Significant gastrointestinal symptoms, disease or surgery;
Current gallbladder or pancreatic disease;
Cardiovascular or respiratory diseases;
Any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above);
Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal function, body weight or appetite (eg domperidone and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.);
Individuals with low ferritin levels (less than 30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study;
Lactose intolerance/other food allergy(ies);
Vegetarians;
Restrained eaters (score >12 on the three factor eating questionnaire).
Current intake of greater than 2 standard drinks on greater than 5 days per week;
Current smokers of cigarettes/cigars/marijuana;
Current intake of any illicit substance;
High performance athletes;
Inability to comprehend study protocol;
Unable to tolerate naso-gastric tube;

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 subject number and randomised treatment for each study visit. Randomisation involves contacting the holder (study assistant) of the randomisation table to inform them of subjects details and study dates. The unblinded study assistant is therefore responsible for allocationg a random treatment to the subject and preparing the solution on each study day.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation is generated using a randomization plan generator available at www.randomization.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

Pharmacokinetics / pharmacodynamics

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

28/05/2018

Actual

28/05/2018

Date of last participant enrolment

Anticipated

4/12/2018

Actual

4/01/2019

Date of last data collection

Anticipated

21/12/2018

Actual

18/01/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Christine Feinle-Bisset

Address

Discipline of Medicine
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]

Individual

Name [1]

Michael Horowitz

Address [1]

Discipline of Medicine
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce,
Adelaide, SA 5005

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Human Research Ethics Committee

Ethics committee address [1]

Level 3, Roma Mitchell Building
136 North Terrace 
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/10/2016

Approval date [1]

15/11/2016

Ethics approval number [1]

RAH Protocol No. R20161005 HREC/16/RAH/410

Summary

Brief summary

The purpose of this trial is to investigate the dose-related effects of intragastric administration of the bitter agonist, quinine, a non-nutritive (calorie-free) compound, on energy intake at a subsequent ad libitum buffet style meal, plasma gut hormone concentrations, and appetite perceptions.. The relationship between outcomes and the ability to detect bitter in the oral cavity will also be investigated.
We have found previously that specific dietary nutrients, when given into the small intestine in small amounts (and so not contributing significantly to overall energy intake) have the unique ability to substantially stimulate gastrointestinal functions leading to marked energy intake suppression and improvements in postprandial blood glucose. There has been a recent interest in the effects of bitter compounds, some of which also occur in the diet, including thio-urea compounds in certain vegetables or fruit, or quinine in tonic water, with reported effects on gut functions and energy intake suppression. 
This study aims to characterise the dose-related effects of quinine, when delivered intragastrically, in an effort to identify an optimal dose for beneficial effect on the outcomes mentioned herein. This may then guide future research to evaluate hypotheses that observed effects may be further enhanced by combining nutrients with quinine

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Christine Feinle-Bisset

Address

Discipline of Medicine
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce,
Adelaide, SA 5005

Country

Australia

Phone

+61 8 8313 6053

Fax

[email protected]

Contact person for public queries

Name

Christine Feinle-Bisset

Address

Discipline of Medicine
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce,
Adelaide, SA 5005

Country

Australia

Phone

+61 8 8313 6053

Fax

[email protected]

Contact person for scientific queries

Name

Christine Feinle-Bisset

Address

Discipline of Medicine
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce,
Adelaide, SA 5005

Country

Australia

Phone

+61 8 8313 6053

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		In healthy men, intragastric administration of qui... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Intragastric administration of the bitter tastant quinine lowers the glycemic response to a nutrient drink without slowing gastric emptying in healthy men.	2020	https://dx.doi.org/10.1152/AJPREGU.00294.2019

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically