An interventional study of Quinine sham feeding quinine and Gastric quinine in Obesity, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-18.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Prevention
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):
Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral sham feeding of quinine and a gastric capsule containing placebo (cellulose)
Dietary Supplement: Quinine sham feeding quinine · Dietary Supplement: Gastric placebo
Oral sham feeding of placebo (tap water) and a gastric capsule containing quinine
Dietary Supplement: Gastric quinine · Dietary Supplement: Oral sham feeding placebo
Oral sham feeding of quinine and a gastric capsule containing quinine
Dietary Supplement: Quinine sham feeding quinine · Dietary Supplement: Gastric quinine
Oral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose)
Dietary Supplement: Oral sham feeding placebo · Dietary Supplement: Gastric placebo
Oral sham feeding with quinine
A gastric capsule containing quinine
Oral sham feeding with placebo (tap water)
A gastric capsule containing placebo (cellulose)
Ad libitum food intake
Difference in ad libitum meal intake (as measured during ad libitum pasta meal)
Time frame: on each test day at T= 50, 50 minutes after ingestion of the capsule and sham-feeding
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maastricht University Medical Center