Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT03565133
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quinine and Food Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants and investigators will be blinded for the contents of the gastric capsule. Both cannot be blinded for the oral sham feeding'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ad libitum food intake', 'timeFrame': 'on each test day at T= 50, 50 minutes after ingestion of the capsule and sham-feeding', 'description': 'Difference in ad libitum meal intake (as measured during ad libitum pasta meal)'}], 'secondaryOutcomes': [{'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.', 'description': '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.'}, {'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.', 'description': '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.'}, {'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.', 'description': 'Difference in heartrate variability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': '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.\n\nObjective: To investigate the effect of oral sham feeding and intragastric delivery of a bitter tastant on food intake.\n\nSecondary Objective(s):\n\n1. To compare the effect of oral sham feeding and intragastric delivery of a bitter tastant on satiation.\n2. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on gastrointestinal symptoms/complaints.\n3. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on heart rate variability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Based on medical history and previous examination, no gastrointestinal complaints and/or gastrointestinal disorders can be defined.\n* Age ≥18 and ≤65 years. This study will include healthy adult subjects (male and female).\n* BMI ≥18 and ≤25 kg/m2\n* Body weight stable over at least the last 6 months (≤ 5% weight change allowed)\n\nExclusion Criteria:\n\n* 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.\n* 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\n* 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\n* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy and hysterectomy allowed, and other surgery upon judgement of medical doctor and principle investigator)\n* Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)\n* Unwillingness to eat lasagna Bolognese meal\n* Pregnancy, lactation\n* Excessive alcohol consumption (\\>20 alcoholic consumptions per week)\n* Smoking\n* Non-tasters of bitter'}, 'identificationModule': {'nctId': 'NCT03565133', 'briefTitle': 'Quinine and Food Intake', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Quinine on Food Intake: Oral Sham Feeding Versus Intragastric Delivery', 'orgStudyIdInfo': {'id': 'METC183012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral quinine, gastric placebo', 'description': 'Oral sham feeding of quinine and a gastric capsule containing placebo (cellulose)', 'interventionNames': ['Dietary Supplement: Quinine sham feeding quinine', 'Dietary Supplement: Gastric placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Oral placebo, gastric quinine', 'description': 'Oral sham feeding of placebo (tap water) and a gastric capsule containing quinine', 'interventionNames': ['Dietary Supplement: Gastric quinine', 'Dietary Supplement: Oral sham feeding placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Oral quinine, gastric quinine', 'description': 'Oral sham feeding of quinine and a gastric capsule containing quinine', 'interventionNames': ['Dietary Supplement: Quinine sham feeding quinine', 'Dietary Supplement: Gastric quinine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral placebo, gastric placebo', 'description': 'Oral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose)', 'interventionNames': ['Dietary Supplement: Oral sham feeding placebo', 'Dietary Supplement: Gastric placebo']}], 'interventions': [{'name': 'Quinine sham feeding quinine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral sham feeding with quinine', 'armGroupLabels': ['Oral quinine, gastric placebo', 'Oral quinine, gastric quinine']}, {'name': 'Gastric quinine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A gastric capsule containing quinine', 'armGroupLabels': ['Oral placebo, gastric quinine', 'Oral quinine, gastric quinine']}, {'name': 'Oral sham feeding placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral sham feeding with placebo (tap water)', 'armGroupLabels': ['Oral placebo, gastric placebo', 'Oral placebo, gastric quinine']}, {'name': 'Gastric placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A gastric capsule containing placebo (cellulose)', 'armGroupLabels': ['Oral placebo, gastric placebo', 'Oral quinine, gastric placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5928 RC', 'city': 'Venlo', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}