Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT01910558
Status:
WITHDRAWN
Last Update Posted:
2016-04-27
First Post:
2013-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C032613', 'term': 'alpha-cyclodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Cancelled by Sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-25', 'studyFirstSubmitDate': '2013-07-22', 'studyFirstSubmitQcDate': '2013-07-25', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fecal Fat Excretion compared at three time periods.', 'timeFrame': 'Assessment of change at each fourth, fifth, and sixth day of each feeding period.', 'description': 'Each subject will consume a different product every six consecutive days which is called a feeding period. On the fourth, fifth, and sixth day of each feeding period, a comparison of fat excretion will be measured through a stool sample. These feeding periods will occur for three consecutive six days totaling eighteen days of feeding. 6+6+6=18'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'The duration of the 18 days in the study.', 'description': 'Subjects will be asked if they experienced any adverse events. All adverse events will be recorded and evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alpha-cyclodextrin', 'Dietary fiber', 'Fecal fat', 'Saturated fat'], 'conditions': ['Obesity', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '21127475', 'type': 'BACKGROUND', 'citation': 'Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of alpha-cyclodextrin on blood lipids and weight loss in healthy humans. Obesity (Silver Spring). 2011 Jun;19(6):1200-4. doi: 10.1038/oby.2010.280. Epub 2010 Dec 2.'}, {'pmid': '17013969', 'type': 'BACKGROUND', 'citation': 'Grunberger G, Jen KL, Artiss JD. The benefits of early intervention in obese diabetic patients with FBCx: a new dietary fibre. Diabetes Metab Res Rev. 2007 Jan;23(1):56-62. doi: 10.1002/dmrr.687.'}, {'pmid': '16423626', 'type': 'BACKGROUND', 'citation': 'Artiss JD, Brogan K, Brucal M, Moghaddam M, Jen KL. The effects of a new soluble dietary fiber on weight gain and selected blood parameters in rats. Metabolism. 2006 Feb;55(2):195-202. doi: 10.1016/j.metabol.2005.08.012.'}]}, 'descriptionModule': {'briefSummary': 'Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to selectively reduce saturated fat and calories which will have a medically beneficial effect on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α- cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal fat on a high saturated fat diet compared to the same diet supplemented with a digestible carbohydrate control', 'detailedDescription': 'Alpha-cyclodextrin which functions as a soluble dietary fiber, has been shown to a form a stable emulsion with dietary fat in the ratio of 1:9, with a higher affinity for saturated fat compared to unsaturated fat. In humans, supplementation with α-cyclodextrin has been shown to lead to a significant weight loss regardless of whether energy intake was maintained or increased.The aim of this study is to evaluate the results of a 72 hour fecal fat test using stool markers on the last three days of each of three six-day feeding periods. Subjects will be served a weight maintaining diet containing 40% fat (of which 40% will be saturated), 30% protein and 30% carbohydrate for 18 days. Subjects will also consume 1 gram alpha cyclodextrin with 1 gram of starch, 2 grams of alpha cyclodextrin, or 2 grams of starch in capsule form before breakfast, lunch, and dinner every day in each of the three six-day feeding periods. At this dose, alpha-cyclodextrin is recognized as safe by the FDA. All stools will be collected over a 72 hour period at the end of each feeding period and analyzed for fecal fat excretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 20 and 30 kg/m2 inclusive\n* Weight ≥ 65 kg for females, and ≥ 55 kg for males\n\nExclusion Criteria:\n\n* Pregnant or nursing.\n* Diabetes Mellitus\n* Any medication to reduce lipids\n* History of gastrointestinal surgery, except for cholecystectomy or appendectomy\n* History of malabsorption'}, 'identificationModule': {'nctId': 'NCT01910558', 'acronym': 'FAT ABSORBER', 'briefTitle': 'The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion', 'orgStudyIdInfo': {'id': 'PBRC 2013-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alpha-cyclodextrin and digestible starch', 'description': 'Supplementation with three grams alpha cyclodextrin with three grams of digestible starch', 'interventionNames': ['Dietary Supplement: Alpha-cyclodextrin']}, {'type': 'EXPERIMENTAL', 'label': 'Alpha-cyclodextrin', 'description': 'Supplementation with six grams of alpha-cyclodextrin', 'interventionNames': ['Dietary Supplement: Alpha-cyclodextrin and digestible starch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Digestible Starch', 'description': 'Supplementation with six grams of digestible starch', 'interventionNames': ['Dietary Supplement: Digestible starch']}], 'interventions': [{'name': 'Alpha-cyclodextrin and digestible starch', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch', 'armGroupLabels': ['Alpha-cyclodextrin']}, {'name': 'Alpha-cyclodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin', 'armGroupLabels': ['Alpha-cyclodextrin and digestible starch']}, {'name': 'Digestible starch', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch', 'armGroupLabels': ['Digestible Starch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Frank L Greenway, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Quest Nutrition LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Frank Greenway', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}