Quinine and Food Intake

NCT ID: NCT03565133

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-17
• Study Completion Date: 2019-08-15

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Oral quinine, gastric placebo

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

Group Type: EXPERIMENTAL

Quinine sham feeding quinine

Intervention Type: DIETARY_SUPPLEMENT

Oral sham feeding with quinine

Gastric placebo

Intervention Type: DIETARY_SUPPLEMENT

A gastric capsule containing placebo (cellulose)

Oral placebo, gastric quinine

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

Group Type: EXPERIMENTAL

Gastric quinine

Intervention Type: DIETARY_SUPPLEMENT

A gastric capsule containing quinine

Oral sham feeding placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral sham feeding with placebo (tap water)

Oral quinine, gastric quinine

Oral sham feeding of quinine and a gastric capsule containing quinine

Group Type: EXPERIMENTAL

Quinine sham feeding quinine

Intervention Type: DIETARY_SUPPLEMENT

Oral sham feeding with quinine

Gastric quinine

Intervention Type: DIETARY_SUPPLEMENT

A gastric capsule containing quinine

Oral placebo, gastric placebo

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

Group Type: PLACEBO_COMPARATOR

Oral sham feeding placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral sham feeding with placebo (tap water)

Gastric placebo

Intervention Type: DIETARY_SUPPLEMENT

A gastric capsule containing placebo (cellulose)

Interventions

Quinine sham feeding quinine

Oral sham feeding with quinine

Intervention Type: DIETARY_SUPPLEMENT

Gastric quinine

A gastric capsule containing quinine

Intervention Type: DIETARY_SUPPLEMENT

Oral sham feeding placebo

Oral sham feeding with placebo (tap water)

Intervention Type: DIETARY_SUPPLEMENT

Gastric placebo

A gastric capsule containing placebo (cellulose)

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht University

Venlo, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

METC183012

Identifier Type: -

Identifier Source: org_study_id