Effect of Bitter in Overweight Female Volunteers

• Status: Unknown status
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

We want to investigate whether an acute administration of hydroxychloroquine sulphate affects hedonic food intake, appetite related sensations and gastrointestinal hormone release in overweight female subjects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Hydroxychloroquine

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.

• Subject is allowed to take 2 Plaquenil capsuls for one visit with a maximal dose of 6.5 mg hydroxychloroquine sulphate per kg bodyweight.

• Women of child-bearing potential 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 is on a diet to induce weight loss or any other treatment for obesity.

• Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.

• 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 shows abnormal eating behavior or has 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 (> 500 ml 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.

• Recent participation (<30 days) or simultaneous participation in another clinical study.

• Subjects with lactose intolerance.

• Subjects with quinine allergy.