Effect of Quinine Hydrochloride in Overweight Population on Food Intake, Hunger and Gut Peptide Release

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Apr 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called quinine hydrochloride on hunger and food intake in overweight women. The researchers want to see if quinine can help reduce feelings of hunger and possibly aid in weight management. Previous studies showed that quinine might decrease hunger sensations in healthy women, and this trial aims to determine if the same effect occurs in women who are overweight.

To participate in this study, women must be between 18 and 65 years old and have a body mass index (BMI) between 25 and 30, which indicates they are overweight. They should also have maintained a stable weight for at least three months before starting the trial. Participants will need to agree to use effective birth control during the study and be in good health overall, meaning they shouldn’t have significant medical conditions or be on certain medications. Those who join the trial can expect to receive the quinine solution during the study and will be monitored to see how it affects their hunger and food intake.

Gender

FEMALE

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.