ObesityPhase 1NCT04873011
Effect of Quinine Hydrochloride in Overweight Population on Food Intake, Hunger and Gut Peptide Release
A Phase 1 study testing Quinine Hydrochloride in people with Obesity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The worldwide increase in the prevalence of obesity is a cause of great concern. Pharmacological treatment options are being explored at the moment with a major focus on the hormones produced by the gastrointestinal tract which regulate hunger and satiation/satiety. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Quinine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Oct 2020to 29 Oct 2025
- Phase
- Phase 1
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is female between 18 and 65 years of age.
- Subject has a BMI between 25 and 30 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable weight during the study visits.
- Women of child-bearing age agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
Who cannot join
- Subject is under age of legal consent, male, pregnant or breastfeeding.
- Subject with a BMI ≤ 25 kg/m² or BMI ≥ 30 kg/m².
- Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
- Subject is currently following a weight loss diet or other treatment for obesity.
- Subject has diabetes.
- Subject has a significant heart, lung, liver or kidney disease.
Show all 20Show fewer
- Subject has a QT-interval > 450 ms.
- Subject has any history of a neurological disorder.
- Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
- Subject has retinopathy.
- Subject suffers from psoriasis.
- Subject has porphyria.
- Subject has a hematologic disorder (e.g. hemolysis, thrombocytopenia).
- Subject shows abnormal eating behavior or has a history of an eating disorder.
- History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity.
- History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
- Subject consumes excessive amounts of alcohol, defined as >14 units per week.
- Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including "recreational use") of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study.
- High caffeine intake (> 4 cups of coffee daily or equivalent).
- Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
TARGID
Leuven, Vlaams-Brabant, 3000
Wout Verbeure, wout.verbeure@kuleuven.be
Jan Tack
About this study
Official title: The Effect of Quinine Hydrochloride on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Overweight Female Subjects
The worldwide increase in the prevalence of obesity is a cause of great concern. Pharmacological treatment options are being explored at the moment with a major focus on the hormones produced by the gastrointestinal tract which regulate hunger and satiation/satiety. Modulating the release of these hormones via bitter substances reduced appetite-related sensations and gastrointestinal motility in lean female volunteers.
Intragastric administration of a quinine-solution has shown to decrease hunger sensations in healthy female volunteers. Now, we want to examine whether this effect is still seen in an overweight female population.
Read the detailed description
The aim of this study is to investigate the effect of acute administration of quinine hydrochloride on the consumed milkshake volume, gastrointestinal hormone levels, appetite-related sensations and whole blood glucose levels in overweight female individuals.
This study is a randomized, placebo-controlled, double blinded, cross-over study. Forty healthy overweight females will be recruited. An acute dose of 320 mg of quinine hydrochloride is administered as a solution via a nasogastric feeding tube. Blood samples will be collected at regular time points to measure gastrointestinal hormone release and whole blood glucose levels. Appetite related sensations will be scored at regular time points on visual analogue scales.
- Conditions
- Obesity
- Being tested
- Quinine Hydrochloride, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinine HydrochlorideDrug
After a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of the quinine hydrochloride solution will be infused into the stomach in a randomized, double-blinded fashion
PlaceboDrug
After a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of water will be infused into the stomach in a randomized, double-blinded fashion
| Study group | Role | What they receive |
|---|---|---|
| Quinine hydrochloride | Experimental | The bitter tastant, quinine hydrochloride, will be acutely infused via a nasogastric feeding tube into the stomach. 320 mg of quinine hydrochloride is dissolved in 10 mL of water and all is infused. Receives: Drug: Quinine Hydrochloride |
| Placebo | Placebo comparator | 10 mL of water is infused via a nasogastric feeding tube into the stomach. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect changes in consumed milkshake volume after acute administration of quinine hydrochloride compared to placebo.
Hedonic food intake will be assessed using a chocolate milkshake drinking task. Subjects are instructed to drink ad libitum from a chocolate milkshake until fully satiated. The milkshake will be weighted before and after the experiment. 1 g of chocolate milkshake = 1 kcal.
Measured: 60 minutes after quinine hydrochloride or placebo infusion
Secondary outcomes (3)
To detect changes in the release of gastrointestinal hormones after acute administration of quinine hydrochloride compared to placebo.
Gastrointestinal hormone release will be measured in plasma samples collected at regular time points to assess the release of ghrelin, motilin and insulin.
Measured: First sample 10 min prior to administration. Followed by collections every 10 minutes after administration for a period of 90 minutes.
To detect changes in appetite-related sensations after acute administration of quinine hydrochloride compared to placebo.
Hunger, prospective food consumption, satiety, fullness, bloating, belching, cramps and pain will be scored by the subjects on visual analog scales of 100 mm.
Measured: all appetite-related sensations will be scored every 10 minutes for a period of 110 minutes, starting 20 minutes before quinine or placebo infusion and ending 90 minutes after administration
To detect changes in whole blood glucose levels after acute administration of quinine hydrochloride compared to placebo
Whole blood glucose levels will be measured at regular time points with a blood glucose meter.
Measured: First sample 10 min prior to administration. Followed by collections every 10 minutes after administration for a period of 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start29 Oct 2020
- Primary completion29 Oct 2025 (estimated)
- Study completion29 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873011
- Sponsor's protocol ID
- QOW
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Quinine Hydrochloride on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Overweight Female Subjects
- ClinicalTrials.gov ID
- NCT04873011
- Acronym / sponsor ID
- QOW
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 29 Oct 2025 (estimated)
- Study completion
- 29 Oct 2025 (estimated)
- First posted
- 5 May 2021 (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.
The worldwide increase in the prevalence of obesity is a cause of great concern. Pharmacological treatment options are being explored at the moment with a major focus on the hormones produced by the gastrointestinal tract which regulate hunger and satiation/satiety. Modulating the release of these hormones via bitter substances reduced appetite-related sensations and gastrointestinal motility in lean female volunteers.
Intragastric administration of a quinine-solution has shown to decrease hunger sensations in healthy female volunteers. Now, we want to examine whether this effect is still seen in an overweight female population.
Detailed description
The aim of this study is to investigate the effect of acute administration of quinine hydrochloride on the consumed milkshake volume, gastrointestinal hormone levels, appetite-related sensations and whole blood glucose levels in overweight female individuals.
This study is a randomized, placebo-controlled, double blinded, cross-over study. Forty healthy overweight females will be recruited. An acute dose of 320 mg of quinine hydrochloride is administered as a solution via a nasogastric feeding tube. Blood samples will be collected at regular time points to measure gastrointestinal hormone release and whole blood glucose levels. Appetite related sensations will be scored at regular time points on visual analogue scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quinine hydrochloride | Experimental | Drug: Quinine HydrochlorideThe bitter tastant, quinine hydrochloride, will be acutely infused via a nasogastric feeding tube into the stomach. 320 mg of quinine hydrochloride is dissolved in 10 mL of water and all is infused. |
| Placebo | Placebo comparator | Drug: Placebo10 mL of water is infused via a nasogastric feeding tube into the stomach. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is female between 18 and 65 years of age.
- Subject has a BMI between 25 and 30 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable weight during the study visits.
- Women of child-bearing age agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
Key exclusion criteria (20 listed)
- Subject is under age of legal consent, male, pregnant or breastfeeding.
- Subject with a BMI ≤ 25 kg/m² or BMI ≥ 30 kg/m².
- Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
- Subject is currently following a weight loss diet or other treatment for obesity.
- Subject has diabetes.
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 |
|---|---|---|
| Quinine HydrochlorideAfter a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of the quinine hydrochloride solution will be infused into the stomach in a randomized, double-blinded fashion | Drug | Quinine hydrochloride |
| PlaceboAfter a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of water will be infused into the stomach in a randomized, double-blinded fashion | Drug | Placebo |
Primary outcome
To detect changes in consumed milkshake volume after acute administration of quinine hydrochloride compared to placebo.
Time frame: 60 minutes after quinine hydrochloride or placebo infusion
Hedonic food intake will be assessed using a chocolate milkshake drinking task. Subjects are instructed to drink ad libitum from a chocolate milkshake until fully satiated. The milkshake will be weighted before and after the experiment. 1 g of chocolate milkshake = 1 kcal.
3 secondary outcomes
To detect changes in the release of gastrointestinal hormones after acute administration of quinine hydrochloride compared to placebo.
Time frame: First sample 10 min prior to administration. Followed by collections every 10 minutes after administration for a period of 90 minutes.
To detect changes in appetite-related sensations after acute administration of quinine hydrochloride compared to placebo.
Time frame: all appetite-related sensations will be scored every 10 minutes for a period of 110 minutes, starting 20 minutes before quinine or placebo infusion and ending 90 minutes after administration
To detect changes in whole blood glucose levels after acute administration of quinine hydrochloride compared to placebo
Time frame: First sample 10 min prior to administration. Followed by collections every 10 minutes after administration for a period of 90 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quinine Hydrochloride in people with Obesity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Jul 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 Belgium. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wout Verbeure (16373765 ext. +32, wout.verbeure@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect changes in consumed milkshake volume after acute administration of quinine hydrochloride compared to placebo. (time frame: 60 minutes after quinine hydrochloride or placebo infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.