Quinine and Food Intake

Obesity Clinical Trial

Official title:

The Effect of Quinine on Food Intake: Oral Sham Feeding Versus Intragastric Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565133
• Other study ID #: METC183012
• Status: Completed
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: August 15, 2019

Study information

• Verified date: November 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rationale: The appearance of tastants in the small intestine following food ingestion results in the onset of digestion and absorption but can also result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. In this study, we aim to investigate the effects of oral sham feeding and intragastric delivery of a bitter tastant (quinine) on ad libitum food intake, satiation, gastrointestinal symptoms, and heart rate variability.

Objective: To investigate the effect of oral sham feeding and intragastric delivery of a bitter tastant on food intake.

Secondary Objective(s):

1. To compare the effect of oral sham feeding and intragastric delivery of a bitter tastant on satiation.

2. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on gastrointestinal symptoms/complaints.

3. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on heart rate variability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Based on medical history and previous examination, no gastrointestinal complaints and/or gastrointestinal disorders can be defined.

• Age =18 and =65 years. This study will include healthy adult subjects (male and female).

• BMI =18 and =25 kg/m2

• Body weight stable over at least the last 6 months (= 5% weight change allowed)

Exclusion Criteria:

• History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.

• Use of medication that can influence study end-points (to be discussed by medical doctor and principal investigator), including vitamin supplementation, within 14 days prior to testing

• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study

• Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy and hysterectomy allowed, and other surgery upon judgement of medical doctor and principle investigator)

• Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)

• Unwillingness to eat lasagna Bolognese meal

• Pregnancy, lactation

• Excessive alcohol consumption (>20 alcoholic consumptions per week)

• Smoking

• Non-tasters of bitter

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Quinine sham feeding quinine
Oral sham feeding with quinine
• Gastric quinine
A gastric capsule containing quinine
• Oral sham feeding placebo
Oral sham feeding with placebo (tap water)
• Gastric placebo
A gastric capsule containing placebo (cellulose)

Locations

Country	Name	City	State
Netherlands	Maastricht University	Venlo	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ad libitum food intake	Difference in ad libitum meal intake (as measured during ad libitum pasta meal)	on each test day at T= 50, 50 minutes after ingestion of the capsule and sham-feeding
Secondary	Satiation/satiety	Difference in satiation/satiety (as measured by VAS 0-100mm). VAS scores for satiety feelings (e.g., satiety, fullness, hunger, prospective feeding, desire to eat, desire to snack) will be measured using Visual Analogue Scales (VAS, 0 to 100 mm) anchored at the low end with the most negative or lowest intensity feelings (e.g., extremely unpleasant, not at all), and with opposing terms at the high end (e.g., extremely pleasant, very high, extreme). Volunteers will be asked to indicate on a line which place on the scale best reflects their feeling at that moment. The scoring forms will be collected immediately so that they cannot be used as a reference for later scorings.	At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.
Secondary	GI-symptoms	Difference in gastro-intestinal symptoms (as measured by VAS 0-100mm). VAS scores for gastrointestinal symptoms (burning, bloating, belching, cramps, colics, warm sensation, sensation of abdominal fullness, nausea, pain and relaxation/tensness) will be measured using Visual Analogue Scales (VAS, 0 to 100 mm) anchored at the low end with the most negative or lowest intensity feelings (e.g., extremely unpleasant, not at all), and with opposing terms at the high end (e.g., extremely pleasant, very high, extreme). Volunteers will be asked to indicate on a line which place on the scale best reflects their feeling at that moment. The scoring forms will be collected immediately so that they cannot be used as a reference for later scorings.	At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.
Secondary	Heart rate variability	Difference in heartrate variability	At T= -150 mins, T= -15 mins, T= 5 mins, and T= 35 mins, where T= -150 is 150 minutes before ingestion of standardized breakfast meal, T= 0 mins is ingestion of capsule and sham-feeding.