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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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral quinine, gastric placebo | Experimental | Oral sham feeding of quinine and a gastric capsule containing placebo (cellulose) |
|
| Oral placebo, gastric quinine | Experimental | Oral sham feeding of placebo (tap water) and a gastric capsule containing quinine |
|
| Oral quinine, gastric quinine | Experimental | Oral sham feeding of quinine and a gastric capsule containing quinine |
|
| Oral placebo, gastric placebo | Placebo Comparator | Oral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quinine sham feeding quinine | Dietary Supplement | Oral sham feeding with quinine |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Venlo | Limburg | 5928 RC | Netherlands |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Participants and investigators will be blinded for the contents of the gastric capsule. Both cannot be blinded for the oral sham feeding
| Gastric quinine | Dietary Supplement | A gastric capsule containing quinine |
|
| Oral sham feeding placebo | Dietary Supplement | Oral sham feeding with placebo (tap water) |
|
| Gastric placebo | Dietary Supplement | A gastric capsule containing placebo (cellulose) |
|
| 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |