Clinical trial NCT03565133: Quinine and Food Intake
Official title: The Effect of Quinine on Food Intake: Oral Sham Feeding Versus Intragastric Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ad libitum food intake
timeFrame: on each test day at T= 50, 50 minutes after ingestion of the capsule and sham-feeding
Secondary outcomes:
measure: Satiation/satiety
timeFrame: 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.
measure: GI-symptoms
timeFrame: 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.
measure: Heart rate variability
timeFrame: 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.
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References: