Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-06 @ 4:08 PM
Study NCT ID:
NCT02450227
Status:
TERMINATED
Last Update Posted:
2016-03-22
First Post:
2015-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014975', 'term': 'Lutein'}], 'ancestors': [{'id': 'D024341', 'term': 'Xanthophylls'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'It is considered non-achievable to recruit the target number of subjects in the short bowel group (n = 12). 10 participants were recruited.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2015-05-17', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentration of lutein and beta-carotene', 'timeFrame': '15 days', 'description': 'Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.'}], 'secondaryOutcomes': [{'measure': 'Concentration of lutein and beta-carotene in the chylomicron/TLR fraction', 'timeFrame': '24 hours', 'description': 'Changes in concentration of lutein and beta-carotene in the chylomicron/TLR fraction (area under the curve, AUC) 24 hours post first intervention meal in each intervention periods.'}, {'measure': 'Total lutein and beta-carotene sekretion with feces/ileostomy-efflux', 'timeFrame': '48/24 hours', 'description': 'Total lutein and beta-carotene sekretion with feces/ileostomy-efflux 48 and 24 hours postprandial, for healthy and ileostomy patients, respectively.'}, {'measure': 'Concentration of other carotenoids in the chylomicron/TLR fraction', 'timeFrame': '24 hours', 'description': 'Changes in concentration of other carotenoids in the chylomicron/TLR fraction (area under the curve, AUC) 24 hours post first intervention meal in each intervention periods.'}, {'measure': 'Serum concentration of other carotenoids', 'timeFrame': '15 days', 'description': 'Difference in serum concentration of other carotenoids between baseline and the end of each intervention period.'}, {'measure': 'Serum concentration of other fat-soluble vitamins', 'timeFrame': '15 days', 'description': 'Difference in serum concentration of other vitamins (A, E; D, K) between baseline and the end of each intervention period.'}, {'measure': 'Changes in metabolic markers', 'timeFrame': '24 hours', 'description': 'Changes in overall metabolic markers from urine 24 hours postprandial'}, {'measure': 'Changes in metabolic markers', 'timeFrame': '24 hours', 'description': 'Changes in overall metabolic markers in the chylomicron/TLR fraction 24 hours postprandial'}, {'measure': 'Changes in metabolic markers', 'timeFrame': '15 days', 'description': 'Changes in overall metabolic markers in serum at the end of each intervention period.'}, {'measure': 'Level of optical density of the macula lutea', 'timeFrame': 'Baseline', 'description': 'Level of optical density in the macula lutea (MPOD), in the spectra where xanthophyll pigment is absorbing light.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ileostomy; Functional Disturbance', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Absorption and metabolism of carotenoids from two types of spinach preparations will be investigated in two study groups, short bowel/ileostomy and healthy, respectively.\n\nThe study will be conducted as a randomised, controlled, 2-way crossover study in 24 participants (12 in each group), randomized to two sequences (1-2, 2-1) of interventions with a more and a less bio-accessible spinach preparation. The serum, chylomicron and fecal/effluent levels of lutein and beta-carotene will be determined.', 'detailedDescription': 'Absorption and metabolism of carotenoids from two types of spinach preparations will be investigated in two study groups, short bowel/ileostomy and healthy, respectively.\n\nThe study will be conducted as a randomised, controlled, 2-way crossover study. Twenty four participants (12 in each group) will be randomized to two sequences (1-2, 2-1) of interventions with a more and a less bio-accessible spinach preparation (differentiates only on the basis of particle size).\n\nThe intervention period is sub-divided into three parts: run-in period (48 hours) with a standardized low-carotenoid diet, 0-24 hours (follow-up period 1 (FP1)) and 24 hours - 2 weeks (FP2). The intervention periods will be separated by a wash-out period of at least 14 days.\n\nAt start of each intervention, the intervention meal (breakfast) is served, followed by standardized, carotenoid-free meals in the following 24 hours. Participants will in FP1 and FP2 receive an intervention meal every second day. Participants will otherwise keep their habitual diets during these follow-up periods.\n\nStudy participants are asked to collect urine during 24 hours before and after the first intervention meal in each period. They will also collect feces/ileostomy efflux for 24 hours before and after initiation of the intervention for short bowel/ileostomy patients and for 48 periods in the healthy volunteers, respectively. Overnight-fasting serum samples are drawn at day 1, 7 and 15 of each intervention period. On day 1 plasma samples are drawn at 0,1, 3, 4, 6, 7, 9 and 24 hours post first intervention meal.\n\nPlasma and effluent levels of lutein and beta-carotene will be determined and chylomicrons are also separated from these samples for determination of carotenoids.\n\nVolunteers also have their macula examined for density of the yellow spot before and after the intervention. Plasma and effluent levels of other carotenoids as well as fat-soluble vitamins are also determined. The samples will also be subjected to metabolic profiling for further exploration and hypothesis generation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'List of inclusion criteria:\n\n* Healthy adults (18-80 years old)\n* Body Mass Index (BMI) between 18,9-28\n* Normal fasting blood glucose (BS) (1,9-5,6 mmol/L)\n* Tolerates: Potatoes, rice, chicken, meat (non vegan/vegetarian).\n\nList of exclusion criteria:\n\n* Intestinal diseases (among healthy controls), systemic infections, psychiatric disorders, metabolic diseases (incl. diabetes), and any clinical condition/circumstance which assessed by the study official makes the person unfit for participation in the trial.\n* Patients diagnosed with short bowel syndrome (SBS).\n* Chronic or frequent use of medication. Primarily consumption of drugs with known effect/side effects on fat absorption. Further, anticoagulants (Marevan) and systemic treatment with glucocorticoids.\n* Have or have had a drug addiction\n* Smokers\n* Alcohol consumption beyond the recommended (7/14 units per week for women/men, respectively)\n* Intake of vitamins or other supplements (3 months before the study and during the study) (healthy controls). Subjects from the patient group included only with stable intake of dietary supplements through the last 3 months.\n* Sampling or donation of larger amount of blood e.g. as blood donors or to other scientific experiments from 3 months before the study until its completion.\n* allergy or intolerance to any of the foods included in the study.\n* Women who are nursing, pregnant or planning pregnancy\n* Not able to comply with the procedures protocol.\n* Macular degeneration to a degree greeter than or equal to a surface area with one or more drusen larger than 125 microns in diameter in at least one eye.\n* Cataracts, macular- or other ocular disease, preventing depiction of xanthophyll pigment.\n\nThe following separate registered information was additionally recorded for short bowel/ileostomy patients:\n\n* Time since operation (stable, \\>1 year post operation)\n* Type of disease/background for operation\n* Intestinal anatomy (inclusive length and type of residual intestine)\n* Type and doses of vitamin and other types of supplementation'}, 'identificationModule': {'nctId': 'NCT02450227', 'acronym': 'Popeye', 'briefTitle': 'Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices - a Explorative Study in Short-bowel Patients and Healthy Controls - The "Popeye-study"', 'orgStudyIdInfo': {'id': 'M220'}, 'secondaryIdInfos': [{'id': 'H-3-2014-112/46407', 'type': 'OTHER', 'domain': 'The Danish Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spinach - Whole leaf (10 mg lutein)', 'description': '1-2: Group given whole leaf as first intervention Whole leaf spinach (10 mg lutein) given every second day for a 15 days period.\n\nFollowed by:\n\nMinced spinach (10 mg lutein) given every second day for a 15 days period.', 'interventionNames': ['Dietary Supplement: Spinach - Whole leaf (10 mg lutein)', 'Dietary Supplement: Spinach - Minced (10 mg/lutein)']}, {'type': 'EXPERIMENTAL', 'label': 'Spinach - Minced (10 mg lutein)', 'description': '2-1: Group given minced spinach as first intervention Minced spinach (10 mg lutein) given every second day for a 15 days period.\n\nFollowed by:\n\nWhole leaf spinach (10 mg lutein) given every second day for a 15 days period.', 'interventionNames': ['Dietary Supplement: Spinach - Whole leaf (10 mg lutein)', 'Dietary Supplement: Spinach - Minced (10 mg/lutein)']}], 'interventions': [{'name': 'Spinach - Whole leaf (10 mg lutein)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet', 'armGroupLabels': ['Spinach - Minced (10 mg lutein)', 'Spinach - Whole leaf (10 mg lutein)']}, {'name': 'Spinach - Minced (10 mg/lutein)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet', 'armGroupLabels': ['Spinach - Minced (10 mg lutein)', 'Spinach - Whole leaf (10 mg lutein)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen Ø', 'country': 'Denmark', 'facility': 'Rigshospitalet, Department of Gastroenterology, CA-2121'}, {'zip': '1958', 'city': 'Frederiksberg C', 'country': 'Denmark', 'facility': 'Department of Nutrition, Exercise and Sports, University of Copenhagen'}], 'overallOfficials': [{'name': 'Lars O Dragsted, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agroscope Liebefeld-Posieux Research Station ALP', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Herta Messerli Stiftung', 'class': 'UNKNOWN'}, {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Lars Ove Dragsted', 'investigatorAffiliation': 'University of Copenhagen'}}}}