Back to results

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

Primary Purpose

Obesity

Status

Unknown status

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Quinine Hydrochloride

Placebo

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

TARGIDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quinine hydrochloride

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Gastrointestinal hormone release will be measured in plasma samples collected at regular time points to assess the release of ghrelin, motilin and insulin.

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

Hunger, prospective food consumption, satiety, fullness, bloating, belching, cramps and pain will be scored by the subjects on visual analog scales of 100 mm.

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

Whole blood glucose levels will be measured at regular time points with a blood glucose meter.

Full Information

NCT ID

NCT04873011

First Posted

April 29, 2021

Last Updated

April 29, 2021

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT04873011

Brief Title

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

Official Title

The Effect of Quinine Hydrochloride on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Overweight Female Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 29, 2020 (Actual)

Primary Completion Date

October 29, 2022 (Anticipated)

Study Completion Date

October 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The aim of this study is to investigate the effect of acute administration of quinine hydrochloride on the consumed milkshake volume, gastrointestinal hormone levels, appetite-related sensations and whole blood glucose levels in overweight female individuals. This study is a randomized, placebo-controlled, double blinded, cross-over study. Forty healthy overweight females will be recruited. An acute dose of 320 mg of quinine hydrochloride is administered as a solution via a nasogastric feeding tube. 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 analogue scales.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Quinine hydrochloride

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Quinine Hydrochloride

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

60 minutes after quinine hydrochloride or placebo infusion

Secondary Outcome Measure Information:

Title

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

Description

Gastrointestinal hormone release will be measured in plasma samples collected at regular time points to assess the release of ghrelin, motilin and insulin.

Time Frame

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

Title

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

Description

Hunger, prospective food consumption, satiety, fullness, bloating, belching, cramps and pain will be scored by the subjects on visual analog scales of 100 mm.

Time Frame

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

Title

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

Description

Whole blood glucose levels will be measured at regular time points with a blood glucose meter.

Time Frame

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

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

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.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wout Verbeure

Phone

16373765

Ext

+32

wout.verbeure@kuleuven.be

Facility Information:

Facility Name

TARGID

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wout Verbeure

wout.verbeure@kuleuven.be

First Name & Middle Initial & Last Name & Degree

Jan Tack

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs