Effect of Bitter in Overweight Female Volunteers

NCT04005781 | Unknown Phase 4

• 1 other identifier: S62007
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

bitter; quinine; ghrelin; motilin; food intake

Outcome Measures

Primary Outcomes (1)

• The effect of hydroxychloroquine sulphate on hedonic food intake

  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.

  60 min after plaquenil or placebo administration

Secondary Outcomes (3)

• The effect of hydroxychloroquine sulphate on gastrointestinal hormone release

  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.

• The effect of hydroxychloroquine sulphate on glucose

  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.

• The effect of hydroxychloroquine sulphate on appetite-related sensations

  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..

Study Arms (2)

Hydroxychloroquine sulphate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Two placebo tablets will be acutely administered per os with 240 ml of water.

Drug: Placebo

Interventions

Hydroxychloroquine sulphate DRUG

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.

Also known as: Plaquenil

Hydroxychloroquine sulphate

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female volunteers have a higher chance to be more sensitive for bitter compounds because of their genetic background in comparison to males.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Obesity

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jan Tack

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wout Verbeure

CONTACT

16373765; wout.verbeure@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: July 2, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: July 2, 2019

Record last verified: 2019-07