Investigating the effects of quinine on appetite in overweight women

The Effect of Quinine Hydrochloride on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Overweight Female Subjects

This study is testing if quinine can change how much food overweight women want to eat and how their bodies respond to hunger hormones.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 1 site (Leuven, Vlaams-Brabant)
• Trial ID: NCT04873011 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate how quinine hydrochloride affects food intake, hunger sensations, and gut hormone release in overweight females. It is a randomized, placebo-controlled, double-blinded, cross-over design involving 40 participants. Each participant will receive an acute dose of quinine administered via a nasogastric feeding tube, with blood samples taken to measure hormone levels and glucose. Appetite sensations will be assessed using visual analogue scales at various time points.

Who should consider this trial

Good fit: Ideal candidates are healthy overweight females aged 18 to 65 with a stable BMI between 25 and 30 kg/m².

Not a fit: Patients who are under 18 years of age or have a BMI outside the specified range will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new pharmacological approach to managing obesity by modulating appetite and hormone release.

How similar studies have performed: Previous studies have shown that bitter substances can reduce appetite in lean individuals, but this approach in overweight populations is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Leuven, Vlaams-Brabant

• Targid — Leuven, Vlaams-Brabant, Belgium (Recruiting)

Study contacts

• Study coordinator: Wout Verbeure

Conditions Obesity