Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-22 @ 7:14 AM
Study NCT ID:
NCT02221050
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2014-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodialysis and Wanting for Protein-rich Foods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'targetDuration': '15 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-19', 'studyFirstSubmitDate': '2014-08-13', 'studyFirstSubmitQcDate': '2014-08-19', 'lastUpdatePostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of wanting for protein-rich foods', 'timeFrame': '20 min (from 8:00 to 8:20 am) and 20 min (from 11:00 to 11:20 am)', 'description': 'The wanting is determined after the successive presentation (for ten seconds) of 18 pictures of food. For each food the question is "at the present time, do you want to eat this food? ". For each photo, subjects place a vertical line on a 10 cm horizontal line bounded at its ends by "no desire" and "extremely envy" (visual analog scale).The wanting for proteins is the mean score for the desire to eat protein-rich foods.'}], 'secondaryOutcomes': [{'measure': 'Concentrations of the plasma amino-acids', 'timeFrame': '8:30 am and 11:30 am', 'description': 'Variation in concentrations of amino-acids during the morning a day with hemodialysis and a day without hemodialysis, and comparison with plasma AAs from healthy subjects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Failure']}, 'referencesModule': {'references': [{'pmid': '32723525', 'type': 'DERIVED', 'citation': 'Mouillot T, Filancia A, Boirie Y, Brindisi MC, Hafnaoui N, Van Wymelbeke V, Teillet E, Meintani I, Jacquin-Piques A, Leloup C, Penicaud L, Mousson C, Brondel L. Hemodialysis Affects Wanting and Spontaneous Intake of Protein-Rich Foods in Chronic Kidney Disease Patients. J Ren Nutr. 2021 Mar;31(2):164-176. doi: 10.1053/j.jrn.2020.05.006. Epub 2020 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'A study conducted in the laboratory revealed the existence of a "window" during which patients with renal failure appreciate the protein-rich foods. This period, located immediately after the dialysis, is likely related to the purification of plasma products resulting from protein catabolism. It therefore appears necessary to understand the mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone), leptin (anorectic hormone) and plasma amino acids.', 'detailedDescription': 'In 24 patients with renal failure treated by hemodialysis, it is evaluated (at 8:00 am and at 11:00 am), a day without hemodialysis and another day after the hemodialysis:\n\n* Hunger sensation,\n* Olfactory liking assessed separately for 6 foods (2 carbohydrate-, 2 fat- and 2 protein-rich foods) and 2 non-alimentary products,\n* Food wanting evaluated by the sequential presentation of 18 images of food (6 fat-, 6 carbohydrate- and 6 protein-rich foods),\n* Two blood samples for the assays of leptin, ghrelin, creatinine, albumin and pre-albumin as well as plasma amino acids.\n\n 24 healthy subjects are also evaluated in order to compare the results from patients to those of control subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'hemodialysis centers of Clinique Drevon, Dijon, France la Breuchillière, Saint Apollinaire, France University Hospital, Dijon, France Macon Hospital, Macon, France', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients and healthy subjects were included if they were aged between 18 and 80 years\n\nExclusion Criteria:\n\n* diabetes, advanced undernutrition (BMI \\< 17.5 kg m-2, prealbumin \\< 250 mg.L-1), congestive heart failure, acute or chronic infection, ongoing antibiotic treatment, active cancer, liver cirrhosis, smoking (more than 5 cigarettes/day), alcohol consumption (more than 3 units/day), aversion to the foods eaten or smelt during the study, impaired comprehension of the cognitive tasks'}, 'identificationModule': {'nctId': 'NCT02221050', 'briefTitle': 'Hemodialysis and Wanting for Protein-rich Foods', 'organization': {'class': 'OTHER', 'fullName': 'University of Burgundy'}, 'officialTitle': 'Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods', 'orgStudyIdInfo': {'id': '2013/28'}}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'state': 'Burgundy', 'country': 'France', 'facility': 'Centre des Sciences du Goût', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'overallOfficials': [{'name': 'Luc PENICAUD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre des Sciences du Goût, Centre National de la recherche Scientifique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Burgundy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University professor', 'investigatorFullName': 'Laurent BRONDEL', 'investigatorAffiliation': 'University of Burgundy'}}}}