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Effect of Bitter in Overweight Female Volunteers (PLAQOW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005781
Recruitment Status : Unknown
Verified July 2019 by Universitaire Ziekenhuizen KU Leuven.
Recruitment status was:  Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Hydroxychloroquine sulphate Drug: Placebo Phase 4

Detailed Description:
Intragastric administration of a quinine-solution has shown to decrease hedonic food intake in healthy female volunteers. The effect of a tablet containing hydroxychloroquine sulphate on hedonic food intake in overweight female individuals has not been studied to date. The primary outcome of the current study is to evaluate the effect of hydroxychloroquine sulphate on hedonic food intake, assessed by ad libitum food intake of a chocolate milkshake one hour after dosing. The study is a randomized, placebo-controlled, double blinded cross-over study. Forty overweight females will be recruited. An acute dose of 400 mg hydroxychloroquine sulphate will be administered. 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 analog scales.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Hydroxychloroquine Sulphate on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Overweight Female Subjects
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Hydroxychloroquine sulphate
Plaquenil (hydroxychloroquine sulphate) will be acutely administered per os with 240 ml of water. Two tablets of 200 mg hydroxychloroquine sulphate each will be given.
Drug: Hydroxychloroquine sulphate
After a stabilization period of 20 min and 10 min after the first blood collection, Plaquenil (Hydroxychloroquine sulfate) will be administered per os (total dose of 400 mg) in a randomized, double-blinded fashion.
Other Name: Plaquenil

Placebo Comparator: Placebo
Two placebo tablets will be acutely administered per os with 240 ml of water.
Drug: Placebo
After a stabilization period of 20 min and 10 min after the first blood collection, Placebo will be administered per os (2 tablets) in a randomized, double-blinded fashion.




Primary Outcome Measures :
  1. The effect of hydroxychloroquine sulphate on hedonic food intake [ Time Frame: 60 min after plaquenil or placebo administration ]
    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 and 1 g of chocolate milkshake = 1 kcal.


Secondary Outcome Measures :
  1. The effect of hydroxychloroquine sulphate on gastrointestinal hormone release [ Time Frame: First sample 10 min prior to administration. Followed by collections every 10 min after administration for a period of one hour. A final blood sample will be collected 30 min after consumption of the chocolate milkshake. ]
    Gastrointestinal hormone release will be measured in plasma samples collected at regular time points to assess the release of ghrelin and motilin.

  2. The effect of hydroxychloroquine sulphate on glucose [ Time Frame: First sample 10 min prior to administration. Followed by collections every 10 min after administration for a period of one hour. A final blood sample will be collected 30 min after consumption of the chocolate milkshake. ]
    Whole blood glucose levels will be measured at regular time points with a blood glucose meter.

  3. The effect of hydroxychloroquine sulphate on appetite-related sensations [ Time Frame: All appetite-related sensations will be scored every 10 min for a period of 110 minutes, starting 20 min before plaquenil or placebo administration and ending 90 min after administration.. ]
    Hunger, prospective food consumption, satiety, fullness, bloating, belching, cramps and pain will be scored by the subjects on visual analog scales of 100 mm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female volunteers have a higher chance to be more sensitive for bitter compounds because of their genetic background in comparison to males.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005781


Contacts
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Contact: Wout Verbeure 16373765 ext +32 wout.verbeure@kuleuven.be

Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
Investigators
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Principal Investigator: Jan Tack UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT04005781    
Other Study ID Numbers: S62007
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Universitaire Ziekenhuizen KU Leuven:
bitter
quinine
ghrelin
motilin
food intake
Additional relevant MeSH terms:
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Overweight
Body Weight
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents