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

• Status: Recruiting
• Trial end date: 2022-10-29
• Target enrollment: 0
• Participant gender: Female

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. 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Quinine

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.