HealthyNCT05682339
Effects of Intragastric Quinine, Alone or Combined With L-isoleucine, on Postprandial Glycaemic Control
A study testing Quinine, L-isoleucine and Combination of quinine and L-isoleucine in people with Healthy, run by University of Adelaide at 1 site in Australia.
Trial summary
In this study, participants will receive, in randomized, double-blind fashion, an intragastric bolus administration of either (i) 300 mg quinine, (ii) 5 g L-isoleucine, (iii) a combination of (i)+(ii), or (iv) control, before 350 ml (500 kcal) of a mixed-nutrient drink, to evaluate the effects on postprandial blood… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Quinine, L-isoleucine and Combination of quinine and L-isoleucine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Jun 2023to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Lean weight (BMI 19-25 kg/m2)
Who cannot join
- 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, bodyweight 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;
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Clinical Research Facility, Adelaide Health and Medical Sciences Building
Adelaide, South Australia, 5005
About this study
In this study, participants will receive, in randomized, double-blind fashion, an intragastric bolus administration of either (i) 300 mg quinine, (ii) 5 g L-isoleucine, (iii) a combination of (i)+(ii), or (iv) control, before 350 ml (500 kcal) of a mixed-nutrient drink, to evaluate the effects on postprandial blood glucose, gastric emptying, and the hormone, and appetite, responses to the mixed-nutrient drink. Study visits will be separated by 3-7 days and participants will receive one treatment per visit.
On each study visit, the participant will be intubated with a nasogastric feeding tube. At t= - 60 min (08:30 am), a baseline blood sample, visual analogue scale questionnaire (VAS), and breath sample will be collected and quinine or control will be administered through the feeding tube. 30 min later (at t= - 30 min), L-isoleucine or control will be administered over 2 min after which the feeding tube will be removed immediately. At t = -45, -30, -15, and -1 min further blood samples will be collected and VAS completed. At t = -1 min, participants will consume, within 1 minute, a mixed-nutrient drink, labeled with 100 mg of 1-13C-acetate for measurement of gastric emptying by breath sampling. Blood samples, VAS, and breath samples will be taken at regular intervals between t = 0-180 min.
Read the detailed description
This trial aims to assess the effects of intragastric administration of quinine, combined with L-isoleucine, on postprandial blood glucose, gastric emptying, gut and gluco-regulatory hormones, as well as appetite perceptions in response to a mixed-nutrient drink.
Each participant will be studied on 4 occasions, separated by 3-7 days. Participants will receive, in randomized, double-blind fashion, an intragastric bolus of (i) 300 mg quinine, (ii) 5 g L-isoleucine, (iii) combination of (i)+(ii), or (iv) control. Due to the low water solubility, L- isoleucine will be provided as a suspension using 5 ml of 'the suspending agent' Ora-Plus (manufactured by Perrigo, Minneapolis). Visits will be carried out 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 standardized dinner meal (400g McCain's beef lasagne) the night before each study visit by no later than 7 pm. 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 8:30 am. Upon arrival, participants will be intubated with a nasogastric, custom-built soft silicon feeding tube (outer diameter: 4mm; Dentsleeve, Mississauga, Ontario, Canada) that will be inserted through an anaesthetized nostril and placed in the stomach. An intravenous cannula will be placed into a right forearm vein for regular blood sampling. At t = -60 min, a venous baseline blood sample (6 ml) will be collected and the participant will complete a visual analogue scale questionnaire (VAS) to assess appetite-related perceptions (fullness, hunger, desire to eat, prospective food consumption) and GI symptoms (nausea and bloating). Immediately thereafter, the participant will receive a 10- ml intragastric bolus of either 300 mg quinine-hydrochloride (Q-HCl) or water (control), and 30 min later, at t -30 min, an intragastric bolus of L-isoleucine (100 ml suspension consisting of 5 g L- isoleucine, 5 ml Ora-Plus and 90 ml 0.9% saline) or control (5 ml Ora-Plus and 95 ml saline) over 1 min after which time the catheter will be removed immediately. At t = -1 min, the participant will consume, within 1 min, a mixed-nutrient drink (Nestle, 500 kcal, 350 ml, 56 g carbohydrates) labelled with 100 mg of 1-13C-acetate for measurement of gastric emptying by breath sampling. Breath samples will be collected in sealed breath bags at baseline (prior to quinine administration) and at regular intervals between t = 0-180 min, for subsequent analysis of 13CO2 concentration in exhaled breath. Blood samples for the measurement of glucose and plasma concentrations of hormones will be taken regularly (12 sampling time points in total), and participant complete VAS questionnaires. At I = 180 min, after final blood and breath samples and VAS measurements, the intravenous cannula will be removed and the participant will be served a light lunch, after which they will be allowed to leave the laboratory.
- Conditions
- Healthy
- Being tested
- Quinine, L-isoleucine, Combination of quinine and L-isoleucine, Control
- Keywords
- Intragastric, Quinine, L-isoleucine, Glycemic control, Plasma glucose, Glucoregulatory hormones, Gastric emptying, Humans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuinineOther
Quinine, which is a bitter compound, extracted from the bark of the cinchona tree and has been shown in our previous studies to lower blood glucose in doses of 300-600 mg, will be 'active' in this condition.
L-isoleucineOther
L-isoleucine, which is a branched-chain amino acid, and one of the building blocks of protein, therefore is part of our daily diet, will be 'active' in this condition.
Combination of quinine and L-isoleucineOther
In this condition, both quinine and L-isoleucine will be administered as 'active'.
ControlOther
In the condition, where quinine is 'active', control for L-isoleucine (5 ml oraplus and 95 ml saline) will be administered. In the condition, where L-isoleucine will be 'active', control for quinine (10 ml distilled water) will be administered.
Whereas, in a control condition, both for quinine and L-isoleucine, a control solution will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Quinine only | Active comparator | In this arm, participants will receive a 10 ml intragastric bolus of 300 mg quinine followed 30 min later by 100 ml intragastric bolus of control for L-isoleucine. Receives: Other: Quinine; Other: Control |
| L-isoleucine only | Active comparator | In this arm, participants will receive a 10 ml intragastric bolus of control for quinine followed 30 min later by 100 ml intragastric bolus of 5 g L-isoleucine. Receives: Other: L-isoleucine; Other: Control |
| Quinine + L-isoleucine | Active comparator | In this arm participants will receive a 10 ml intragastric bolus of 300 mg quinine followed 30 min later by 100 ml intragastric bolus of 5 g L-isoleucine. Receives: Other: Combination of quinine and L-isoleucine |
| Control | Placebo comparator | In this arm, participants will receive a 10 ml intragastric bolus of control solution followed 30 min later by 100 ml intragastric bolus of control solution. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline plasma glucose concentration after a mixed-nutrient drink for 3 hours
Plasma glucose concentrations (mmol/L) will be assessed using glucose oxidase method
Measured: Blood samples will be taken repeatedly within each study visit (i.e. at baseline (t= 0 min), after administration of study treatments (t= -45, -30, -15 min) and after a mixed-nutrient drink (t= 0, 15, 30, 45, 60, 90, 120 and 180 min).
Secondary outcomes (4)
Gastric emptying of a mixed nutrient drink
Measurement of 13CO2 in breath samples, expressed as percentage of 13CO2 recovery per hour
Measured: Breath samples will be taken repeatedly on each study visit (i.e. t= 0 (baseline), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 75, 90, 105,120, 135, 150, 165, 180 minutes) to construct a gastric emptying profile on each day.
Plasma concentration of insulin after a mixed-nutrient drink
Plasma insulin concentrations (mU/L) will be assessed using an ELISA immunoassay
Measured: Blood samples will be taken repeatedly within each study visit (i.e. at baseline (t= 0 min), after administration of study treatments (t= -45, -30, -15 min) and after a mixed-nutrient drink (t= 0, 15, 30, 45, 60, 90, 120 and 180 min).
Plasma concentration of glucagon after a mixed-nutrient drink
Plasma glucagon concentrations (pg/mL) will be measured by radioimmunoassay
Measured: Blood samples will be taken repeatedly within each study visit (i.e. at baseline (t= 0 min), after administration of study treatments (t= -45, -30, -15 min) and after a mixed-nutrient drink (t= 0, 15, 30, 45, 60, 90, 120 and 180 min).
Appetite-related perceptions (fullness, hunger, desire to eat, prospective food consumption) and gastrointestinal symptoms (nausea and bloating)
Appetite-related perceptions and gastrointestinal symptoms will be measured using a 100-mm Visual Analogue Scale (VAS) questionnaire
Measured: VAS ratings will be collected repeatedly within each study visit (i.e. at baseline (t = 0 min), after administration of study treatments (t= -45, -30, -15 min) and after mixed-nutrient drink (t= 0, 15, 30, 45, 60, 90, 120 and 180 min).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start19 Jun 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Feinle-Bisset, University of Adelaide
- Investigators
- Christine Feinle-Bisset, PhD, Principal investigator, University of Adelaide, Adelaide, South Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682339
- Sponsor's protocol ID
- R20161005
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Sajjad M, Ghorbaninejad P, Bitarafan V, Anjom-Shoae J, Rose BD, Fitzgerald PC, Horowitz M, Feinle-Bisset C. Effects of Combined Intragastric Administration of Quinine with L-Leucine or L-Isoleucine on the Glycemic Response to, and Gastric Emptying of, a Mixed-Nutrient Drink in Healthy Males. J Nutr. 2026 Feb;156(2):101259. doi: 10.1016/j.tjnut.2025.101259. Epub 2025 Dec 7.
PubMed 41365468
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intragastric Quinine, Alone or Combined With L-isoleucine, on Postprandial Glycaemic Control
- ClinicalTrials.gov ID
- NCT05682339
- Acronym / sponsor ID
- R20161005
- Conditions
- Healthy
- Keywords
- Intragastric, Quinine, L-isoleucine, Glycemic control, Plasma glucose, Glucoregulatory hormones, Gastric emptying, Humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, participants will receive, in randomized, double-blind fashion, an intragastric bolus administration of either (i) 300 mg quinine, (ii) 5 g L-isoleucine, (iii) a combination of (i)+(ii), or (iv) control, before 350 ml (500 kcal) of a mixed-nutrient drink, to evaluate the effects on postprandial blood glucose, gastric emptying, and the hormone, and appetite, responses to the mixed-nutrient drink. Study visits will be separated by 3-7 days and participants will receive one treatment per visit.
On each study visit, the participant will be intubated with a nasogastric feeding tube. At t= - 60 min (08:30 am), a baseline blood sample, visual analogue scale questionnaire (VAS), and breath sample will be collected and quinine or control will be administered through the feeding tube. 30 min later (at t= - 30 min), L-isoleucine or control will be administered over 2 min after which the feeding tube will be removed immediately. At t = -45, -30, -15, and -1 min further blood samples will be collected and VAS completed. At t = -1 min, participants will consume, within 1 minute, a mixed-nutrient drink, labeled with 100 mg of 1-13C-acetate for measurement of gastric emptying by breath sampling. Blood samples, VAS, and breath samples will be taken at regular intervals between t = 0-180 min.
Detailed description
This trial aims to assess the effects of intragastric administration of quinine, combined with L-isoleucine, on postprandial blood glucose, gastric emptying, gut and gluco-regulatory hormones, as well as appetite perceptions in response to a mixed-nutrient drink.
Each participant will be studied on 4 occasions, separated by 3-7 days. Participants will receive, in randomized, double-blind fashion, an intragastric bolus of (i) 300 mg quinine, (ii) 5 g L-isoleucine, (iii) combination of (i)+(ii), or (iv) control. Due to the low water solubility, L- isoleucine will be provided as a suspension using 5 ml of 'the suspending agent' Ora-Plus (manufactured by Perrigo, Minneapolis). Visits will be carried out 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 standardized dinner meal (400g McCain's beef lasagne) the night before each study visit by no later than 7 pm. 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 8:30 am. Upon arrival, participants will be intubated with a nasogastric, custom-built soft silicon feeding tube (outer diameter: 4mm; Dentsleeve, Mississauga, Ontario, Canada) that will be inserted through an anaesthetized nostril and placed in the stomach. An intravenous cannula will be placed into a right forearm vein for regular blood sampling. At t = -60 min, a venous baseline blood sample (6 ml) will be collected and the participant will complete a visual analogue scale questionnaire (VAS) to assess appetite-related perceptions (fullness, hunger, desire to eat, prospective food consumption) and GI symptoms (nausea and bloating). Immediately thereafter, the participant will receive a 10- ml intragastric bolus of either 300 mg quinine-hydrochloride (Q-HCl) or water (control), and 30 min later, at t -30 min, an intragastric bolus of L-isoleucine (100 ml suspension consisting of 5 g L- isoleucine, 5 ml Ora-Plus and 90 ml 0.9% saline) or control (5 ml Ora-Plus and 95 ml saline) over 1 min after which time the catheter will be removed immediately. At t = -1 min, the participant will consume, within 1 min, a mixed-nutrient drink (Nestle, 500 kcal, 350 ml, 56 g carbohydrates) labelled with 100 mg of 1-13C-acetate for measurement of gastric emptying by breath sampling. Breath samples will be collected in sealed breath bags at baseline (prior to quinine administration) and at regular intervals between t = 0-180 min, for subsequent analysis of 13CO2 concentration in exhaled breath. Blood samples for the measurement of glucose and plasma concentrations of hormones will be taken regularly (12 sampling time points in total), and participant complete VAS questionnaires. At I = 180 min, after final blood and breath samples and VAS measurements, the intravenous cannula will be removed and the participant will be served a light lunch, after which they will be allowed to leave the laboratory.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Quinine only | Active comparator | Other: Quinine, Other: ControlIn this arm, participants will receive a 10 ml intragastric bolus of 300 mg quinine followed 30 min later by 100 ml intragastric bolus of control for L-isoleucine. |
| L-isoleucine only | Active comparator | Other: L-isoleucine, Other: ControlIn this arm, participants will receive a 10 ml intragastric bolus of control for quinine followed 30 min later by 100 ml intragastric bolus of 5 g L-isoleucine. |
| Quinine + L-isoleucine | Active comparator | Other: Combination of quinine and L-isoleucineIn this arm participants will receive a 10 ml intragastric bolus of 300 mg quinine followed 30 min later by 100 ml intragastric bolus of 5 g L-isoleucine. |
| Control | Placebo comparator | Other: ControlIn this arm, participants will receive a 10 ml intragastric bolus of control solution followed 30 min later by 100 ml intragastric bolus of control solution. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Lean weight (BMI 19-25 kg/m2)
Key exclusion criteria (15 listed)
- 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, bodyweight or appetite (eg domperidone and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuinineQuinine, which is a bitter compound, extracted from the bark of the cinchona tree and has been shown in our previous studies to lower blood glucose in doses of 300-600 mg, will be 'active' in this condition. | Other | Quinine only |
| L-isoleucineL-isoleucine, which is a branched-chain amino acid, and one of the building blocks of protein, therefore is part of our daily diet, will be 'active' in this condition. | Other | L-isoleucine only |
| Combination of quinine and L-isoleucineIn this condition, both quinine and L-isoleucine will be administered as 'active'. | Other | Quinine + L-isoleucine |
| ControlIn the condition, where quinine is 'active', control for L-isoleucine (5 ml oraplus and 95 ml saline) will be administered. In the condition, where L-isoleucine will be 'active', control for quinine (10 ml distilled water) will be administered. Whereas, in a control condition, both for quinine and L-isoleucine, a control solution will be administered. | Other | Control, L-isoleucine only, Quinine only |
Primary outcome
Change from baseline plasma glucose concentration after a mixed-nutrient drink for 3 hours
Time frame: Blood samples will be taken repeatedly within each study visit (i.e. at baseline (t= 0 min), after administration of study treatments (t= -45, -30, -15 min) and after a mixed-nutrient drink (t= 0, 15, 30, 45, 60, 90, 120 and 180 min).
Plasma glucose concentrations (mmol/L) will be assessed using glucose oxidase method
4 secondary outcomes
Gastric emptying of a mixed nutrient drink
Time frame: Breath samples will be taken repeatedly on each study visit (i.e. t= 0 (baseline), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 75, 90, 105,120, 135, 150, 165, 180 minutes) to construct a gastric emptying profile on each day.
Plasma concentration of insulin after a mixed-nutrient drink
Time frame: Blood samples will be taken repeatedly within each study visit (i.e. at baseline (t= 0 min), after administration of study treatments (t= -45, -30, -15 min) and after a mixed-nutrient drink (t= 0, 15, 30, 45, 60, 90, 120 and 180 min).
Plasma concentration of glucagon after a mixed-nutrient drink
Time frame: Blood samples will be taken repeatedly within each study visit (i.e. at baseline (t= 0 min), after administration of study treatments (t= -45, -30, -15 min) and after a mixed-nutrient drink (t= 0, 15, 30, 45, 60, 90, 120 and 180 min).
Appetite-related perceptions (fullness, hunger, desire to eat, prospective food consumption) and gastrointestinal symptoms (nausea and bloating)
Time frame: VAS ratings will be collected repeatedly within each study visit (i.e. at baseline (t = 0 min), after administration of study treatments (t= -45, -30, -15 min) and after mixed-nutrient drink (t= 0, 15, 30, 45, 60, 90, 120 and 180 min).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 41365468Sajjad M, Ghorbaninejad P, Bitarafan V, Anjom-Shoae J, Rose BD, Fitzgerald PC, Horowitz M, Feinle-Bisset C. Effects of Combined Intragastric Administration of Quinine with L-Leucine or L-Isoleucine on the Glycemic Response to, and Gastric Emptying of, a Mixed-Nutrient Drink in Healthy Males. J Nutr. 2026 Feb;156(2):101259. doi: 10.1016/j.tjnut.2025.101259. Epub 2025 Dec 7.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Feinle-Bisset, PhD principal investigator
University of Adelaide, Adelaide, South Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quinine, L-isoleucine and Combination of quinine and L-isoleucine in people with Healthy, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline plasma glucose concentration after a mixed-nutrient drink for 3 hours (time frame: Blood samples will be taken repeatedly within each study visit (i.e. at baseline (t= 0 min), after administration of study treatments (t= -45, -30, -15 min) and after a mixed-nutrient drink (t= 0, 15, 30, 45, 60, 90, 120 and 180 min).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.