Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 10:09 PM
Study NCT ID:
NCT06154161
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2023-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D011502', 'term': 'Protein-Energy Malnutrition'}], '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'}, {'id': 'D011488', 'term': 'Protein Deficiency'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '6-month prospective interventional clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum albumin', 'timeFrame': 'up to 6 months of the study', 'description': 'Collection of serum albumin to identify a change from pre-post to analyze the effect protein isolate had on inflammation marker and protein status.'}], 'secondaryOutcomes': [{'measure': 'Total protein', 'timeFrame': 'up to 6 months of the study', 'description': 'Collection of whole blood total protein to identify a change from pre-post to analyze the effect protein isolates had on protein stores.'}, {'measure': 'normalized protein catabolic rate (nPCR)', 'timeFrame': 'up to 6 months of the study', 'description': 'Collection of nPCR through serum to identify a change from pre-post to analyze the effect protein isolates had on nPCR.'}, {'measure': 'mid-arm muscle circumference', 'timeFrame': 'up to 6 months of the study', 'description': 'measuring mid-arm circumference from baseline to the end of the study to determine that protein isolates did not affect muscle mass.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peritoneal dialysis'], 'conditions': ['Renal Failure', 'Protein-Energy Malnutrition']}, 'descriptionModule': {'briefSummary': 'This is a 6-month prospective interventional clinical trial designed to evaluate the impact of whey protein isolate oral supplement on protein status. Differences in protein status will be evaluated with review of the medical chart from standard of care monthly blood collection for serum albumin, total protein, and normalized protein catabolic rate (nPCR) as detected by serum urea nitrogen. Mid-arm circumference and weight will be measured to ensure no significant changes. Quality of life will be measured to detect if the addition of protein aided in overall quality of life. There will be a 3-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. After the recruitment period has finished, eligible participants will sign the consent form in order to participate in the study. At this point, participants will be provided the supplements for the month and instructed with the amount of water and how to mix with the provided measuring and drinking cup.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* diagnosed with stage 5 Chronic Kidney Disease for at least 3 months prior to the starting date of the trial\n* on peritoneal dialysis at least three months prior to the starting date of the trial\n* can provide signed informed consent\n* have no dietary restriction\n* no food allergies\n* no chewing/swallowing difficulties.\n\nExclusion Criteria:\n\n* not meeting the above\n* pregnant/lactating as either self-reported or determined by the medical director\n\n * Chronic Kidney Disease patient stages 1-4.\n * Chronic Kidney Disease patient undergoing hemodialysis.\n* use of other protein supplement'}, 'identificationModule': {'nctId': 'NCT06154161', 'briefTitle': 'Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'WheyproteinPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whey protein consumption', 'description': 'Participants will receive 20g total protein of whey protein isolate in 115 mls of water to consume daily for up to 6 months', 'interventionNames': ['Dietary Supplement: Whey protein supplement']}], 'interventions': [{'name': 'Whey protein supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A monthly supply of 35 g of whey protein isolate will be provided to participants in individual sachet packets with instructions of preparation. Every month, participants will come to the center to provide the standard monthly blood sample. At this time, the PI will have participants complete the quality-of-life instrument, ask if there have been any changes in their dietary habits, and collect weights for up to 6-months. Additionally, participants will indicate if they had consumed the protein daily and/or bring back their empty/full satchel packets. As this is a feasibility trial, it is necessary to determine the compliancy of consuming protein daily and the amount. Furthermore, understanding how protein markers may be affected by consumption of the protein daily vs less frequently throughout the week is important to establish improved recommendations for consumption of protein supplements.', 'armGroupLabels': ['Whey protein consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32606', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Dialysis Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Jeanette M Andrade, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data and files will be secured in locked filling cabinets and office space. Paper questionnaires will only include date and research study assigned participant number. Data that is originally captured as hardcopy/paper (e.g. questionnaires) will be transcribed to encrypted electronic files.\n\nFollowing the completion of the study, any potential identifiers will be removed from data to meet HIPAA de-identification standards (According to the October 2002 Privacy Rule ยง 164.514.(b).2. the indicated information/will be removed from all study records).\n\nUpon publication, de-identified data can be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}