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

NCT04873011 | Recruiting Phase 1

• 1 other identifier: QOW
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• To detect changes in consumed milkshake volume after acute administration of quinine hydrochloride compared to placebo.

  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. 1 g of chocolate milkshake = 1 kcal.

  60 minutes after quinine hydrochloride or placebo infusion

Secondary Outcomes (3)

• To detect changes in the release of gastrointestinal hormones after acute administration of quinine hydrochloride compared to placebo.

  First sample 10 min prior to administration. Followed by collections every 10 minutes after administration for a period of 90 minutes.

• To detect changes in appetite-related sensations after acute administration of quinine hydrochloride compared to placebo.

  all appetite-related sensations will be scored every 10 minutes for a period of 110 minutes, starting 20 minutes before quinine or placebo infusion and ending 90 minutes after administration

• To detect changes in whole blood glucose levels after acute administration of quinine hydrochloride compared to placebo

  First sample 10 min prior to administration. Followed by collections every 10 minutes after administration for a period of 90 minutes.

Study Arms (2)

Quinine hydrochloride

EXPERIMENTAL

The bitter tastant, quinine hydrochloride, will be acutely infused via a nasogastric feeding tube into the stomach. 320 mg of quinine hydrochloride is dissolved in 10 mL of water and all is infused.

Drug: Quinine Hydrochloride

Placebo

PLACEBO COMPARATOR

10 mL of water is infused via a nasogastric feeding tube into the stomach.

Drug: Placebo

Interventions

Quinine Hydrochloride DRUG

After a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of the quinine hydrochloride solution will be infused into the stomach in a randomized, double-blinded fashion

Quinine hydrochloride

Placebo DRUG

After a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of water will be infused into the stomach in a randomized, double-blinded fashion

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female volunteers are lingually more sensitive for the bitter taste compared to males. There are indications that also in the gut, the response is stronger in female volunteers than men.
• 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.
• 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.

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 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

TARGID

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Quinine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Wout Verbeure

CONTACT

16373765; wout.verbeure@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 5, 2021
• Study Start: October 29, 2020
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)