Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-01 @ 9:35 PM
Study NCT ID:
NCT03007368
Status:
COMPLETED
Last Update Posted:
2017-01-02
First Post:
2016-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digestion of Foods Consumed in Africa
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': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-29', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-12-29', 'lastUpdatePostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric emptying', 'timeFrame': 'acute study, 4 hours after consumption of test food', 'description': 'Breath test was performed using 13C-octanoic acid mixed into test meals'}], 'secondaryOutcomes': [{'measure': 'Appetitive response', 'timeFrame': 'acute study, 4 hours after consumption of test food', 'description': 'Fullness and hunger questionnaire was given at various time points after consumption of test foods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity and Other Hyperalimentation']}, 'referencesModule': {'references': [{'pmid': '8500721', 'type': 'BACKGROUND', 'citation': 'Ghoos YF, Maes BD, Geypens BJ, Mys G, Hiele MI, Rutgeerts PJ, Vantrappen G. Measurement of gastric emptying rate of solids by means of a carbon-labeled octanoic acid breath test. Gastroenterology. 1993 Jun;104(6):1640-7. doi: 10.1016/0016-5085(93)90640-x.'}, {'pmid': '9097998', 'type': 'BACKGROUND', 'citation': 'Choi MG, Camilleri M, Burton DD, Zinsmeister AR, Forstrom LA, Nair KS. [13C]octanoic acid breath test for gastric emptying of solids: accuracy, reproducibility, and comparison with scintigraphy. Gastroenterology. 1997 Apr;112(4):1155-62. doi: 10.1016/s0016-5085(97)70126-4.'}, {'pmid': '20443742', 'type': 'BACKGROUND', 'citation': 'Clegg ME, Shafat A. Procedures in the 13C octanoic acid breath test for measurement of gastric emptying: analysis using Bland-Altman methods. Scand J Gastroenterol. 2010 Aug;45(7-8):852-61. doi: 10.3109/00365521.2010.483740.'}, {'pmid': '6776794', 'type': 'BACKGROUND', 'citation': 'Schoeller DA, Klein PD, Watkins JB, Heim T, MacLean WC Jr. 13C abundances of nutrients and the effect of variations in 13C isotopic abundances of test meals formulated for 13CO2 breath tests. Am J Clin Nutr. 1980 Nov;33(11):2375-85. doi: 10.1093/ajcn/33.11.2375.'}]}, 'descriptionModule': {'briefSummary': 'As populations become urbanized in Africa, the change to a more Westernized diet has been associated with rise in obesity and related metabolic syndrome diseases. The current study shows that in the West African Sahel, these replacement starchy staple foods have fast gastric emptying compared to traditional sorghum and millet foods; and implies that the latter could be beneficial in lowering glycemic response, providing energy from a meal over a longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and millet foods could be useful to improve their image in West African cities to increase their consumption and to improve markets for local smallholder farmers.', 'detailedDescription': 'As suggested by anecdotal evidence that traditional Malian sorghum and millet foods are filling and provide sustained energy, we hypothesized that gastric emptying rates of sorghum and millet foods are slow, particularly compared to non-traditional starchy foods (white rice, potato, wheat pasta) that are now commonly consumed in urban areas of the West African Sahel. A broader purpose for the study was to understand whether sorghum and millet foods have positive health attributes that can be promoted in urban areas to provide better markets for local farmers.\n\nTwo human trials of similar design were conducted approximately one year apart. The carbon 13 (13C)-labelled octanoic acid breath test method was used to measure gastric emptying rate, and subjective pre-test and satiety response questionnaires were used. In the first study, 14 healthy volunteers in Bamako, Mali participated in a crossover design to test eight starchy foods for gastric emptying rate and satiety feelings. The second study with six volunteers was done to correct for endogenous 13C differences in the starch component of the foods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)\n\nExclusion Criteria:\n\n* Under any medication\n* History of any gastrointestinal disease or surgery\n* Diabetes\n* Smoker'}, 'identificationModule': {'nctId': 'NCT03007368', 'briefTitle': 'Digestion of Foods Consumed in Africa', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Assessment of Gastric Emptying and Fullness of Different Types of Foods in Mali', 'orgStudyIdInfo': {'id': '1104010761'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rice', 'description': 'Cooked white rice and tomato-based sauce', 'interventionNames': ['Other: Rice']}, {'type': 'EXPERIMENTAL', 'label': 'Potato', 'description': 'Cooked white peeled potato and tomato-based sauce', 'interventionNames': ['Other: Potato']}, {'type': 'EXPERIMENTAL', 'label': 'Pasta', 'description': 'Cooked macaroni product and tomato-based sauce', 'interventionNames': ['Other: Pasta']}, {'type': 'EXPERIMENTAL', 'label': 'Sorghum thick porridge', 'description': 'Sorghum thick porridge and tomato-based sauce', 'interventionNames': ['Other: Sorghum thick porridge']}, {'type': 'EXPERIMENTAL', 'label': 'Millet thick porridge', 'description': 'Millet thick porridge and tomato-based sauce', 'interventionNames': ['Other: Millet thick porridge']}, {'type': 'EXPERIMENTAL', 'label': 'Millet couscous', 'description': 'Cooked millet couscous and tomato-based sauce', 'interventionNames': ['Other: Millet couscous']}, {'type': 'EXPERIMENTAL', 'label': 'Millet thin porridge', 'description': 'Millet thin porridge', 'interventionNames': ['Other: Millet thin porridge']}, {'type': 'EXPERIMENTAL', 'label': 'Millet thin monikuru porridge', 'description': 'Millet thin porridge containing cooked millet granules (monikuru)', 'interventionNames': ['Other: Millet thin monikuru porridge']}], 'interventions': [{'name': 'Rice', 'type': 'OTHER', 'description': 'Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.', 'armGroupLabels': ['Rice']}, {'name': 'Potato', 'type': 'OTHER', 'description': 'Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response .', 'armGroupLabels': ['Potato']}, {'name': 'Pasta', 'type': 'OTHER', 'description': 'Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.', 'armGroupLabels': ['Pasta']}, {'name': 'Sorghum thick porridge', 'type': 'OTHER', 'description': 'Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.', 'armGroupLabels': ['Sorghum thick porridge']}, {'name': 'Millet thick porridge', 'type': 'OTHER', 'description': 'Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.', 'armGroupLabels': ['Millet thick porridge']}, {'name': 'Millet couscous', 'type': 'OTHER', 'description': 'Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.', 'armGroupLabels': ['Millet couscous']}, {'name': 'Millet thin porridge', 'type': 'OTHER', 'description': 'Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.', 'armGroupLabels': ['Millet thin porridge']}, {'name': 'Millet thin monikuru porridge', 'type': 'OTHER', 'description': 'Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.', 'armGroupLabels': ['Millet thin monikuru porridge']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylor College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruce R. Hamaker', 'investigatorAffiliation': 'Purdue University'}}}}