Quinine and Food Intake

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Quinine sham feeding quinine; Dietary supplement: Gastric placebo; Dietary supplement: Gastric quinine; Dietary supplement: Oral sham feeding placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Venlo, Limburg, Netherlands, 5928 RC
      • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oral quinine, gastric placebo; Oral sham feeding of quinine and a gastric capsule containing placebo (cellulose)	Dietary supplement: Quinine sham feeding quinine; Oral sham feeding with quinine; Dietary supplement: Gastric placebo; A gastric capsule containing placebo (cellulose)
EXPERIMENTAL: Oral placebo, gastric quinine; Oral sham feeding of placebo (tap water) and a gastric capsule containing quinine	Dietary supplement: Gastric quinine; A gastric capsule containing quinine; Dietary supplement: Oral sham feeding placebo; Oral sham feeding with placebo (tap water)
EXPERIMENTAL: Oral quinine, gastric quinine; Oral sham feeding of quinine and a gastric capsule containing quinine	Dietary supplement: Quinine sham feeding quinine; Oral sham feeding with quinine; Dietary supplement: Gastric quinine; A gastric capsule containing quinine
PLACEBO_COMPARATOR: Oral placebo, gastric placebo; Oral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose)	Dietary supplement: Gastric placebo; A gastric capsule containing placebo (cellulose); Dietary supplement: Oral sham feeding placebo; Oral sham feeding with placebo (tap water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2018
• Primary Completion (ACTUAL): August 15, 2019
• Study Completion (ACTUAL): August 15, 2019

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antiprotozoal Agents; Antiparasitic Agents; Neuromuscular Agents; Antimalarials; Muscle Relaxants, Central; Quinine
• Other Study ID Numbers: METC183012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No