Quinine and Food Intake

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Gastric quinine; Dietary Supplement: Oral sham feeding placebo; Dietary Supplement: Quinine sham feeding quinine; Dietary Supplement: Gastric placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03565133

METC183012

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 4 patient groups, including a placebo group

Oral quinine, gastric placebo

Experimental group

Description:

Oral sham feeding of quinine and a gastric capsule containing placebo (cellulose)

Treatment:

Dietary Supplement: Quinine sham feeding quinine

Dietary Supplement: Gastric placebo

Oral placebo, gastric quinine

Experimental group

Description:

Oral sham feeding of placebo (tap water) and a gastric capsule containing quinine

Treatment:

Dietary Supplement: Oral sham feeding placebo

Dietary Supplement: Gastric quinine

Oral quinine, gastric quinine

Experimental group

Description:

Oral sham feeding of quinine and a gastric capsule containing quinine

Treatment:

Dietary Supplement: Quinine sham feeding quinine

Dietary Supplement: Gastric quinine

Oral placebo, gastric placebo

Placebo Comparator group

Description:

Oral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose)

Treatment:

Dietary Supplement: Oral sham feeding placebo

Dietary Supplement: Gastric placebo