Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT05700851
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2022-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immuno-nutrition Supplementation in Haemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.taal@nottingham.ac.uk', 'phone': '01332224618', 'title': 'Prof. Maarten Taal', 'organization': 'University of Nottingham'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Reporting/recording of adverse event data was conducted from the baseline assessment until the end of the 6-week intervention period.', 'eventGroups': [{'id': 'EG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre.", 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Intolerance to the immuno-nutrition supplement', 'notes': 'Participant reported vomiting and diarrhoea after 4 days of taking the immuno-nutrition supplement.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'C Reactive Protein - Marker of Systemic Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre."}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '22.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'C reactive protein levels in mg/L using a high-sensitive laboratory test', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 - Marker of Systemic Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre."}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '25.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-8 - Marker of Systemic Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre."}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '7.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skeletal Muscle Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre."}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '32.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment.', 'unitOfMeasure': 'kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Skeletal muscle mass assessment requires participants to stand in the InBody equipment; therefore, skeletal muscle mass was not measured in 2 participants due to leg amputations. A contraindication for using the InBody equipment is having body metal implants; therefore, skeletal muscle mass was not measured in 1 participant due to this reason.'}, {'type': 'SECONDARY', 'title': 'Energy Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre."}], 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '22.3', 'upperLimit': '31.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Energy intake in kcal/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics', 'unitOfMeasure': 'kcal/kg of body weight/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Protein Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre."}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Protein intake in g/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics', 'unitOfMeasure': 'g/kg of body weight/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Handgrip Strength - a Measure of Muscle Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre."}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '30.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer', 'unitOfMeasure': 'kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Handgrip strength was not measured in 2 participants due to arthritis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Received a kidney transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Hospitalisation before starting baseline assessments', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.\n\nImmuno-nutrition supplement: Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'C reactive protein', 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'BG000', 'lowerLimit': '4.8', 'upperLimit': '32.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Interleukin-6', 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'BG000', 'lowerLimit': '7.0', 'upperLimit': '22.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Interleukin-8', 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'BG000', 'lowerLimit': '2.4', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Handgrip strength', 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'groupId': 'BG000', 'lowerLimit': '17.1', 'upperLimit': '27.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Skeletal muscle mass', 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'groupId': 'BG000', 'lowerLimit': '25.3', 'upperLimit': '33.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Energy intake', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'BG000', 'lowerLimit': '22.5', 'upperLimit': '33.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kcal/kg of body weight/day', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Protein intake', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'BG000', 'lowerLimit': '0.9', 'upperLimit': '1.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/kg of body weight/day', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-25', 'size': 628934, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-29T08:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2022-09-05', 'resultsFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C Reactive Protein - Marker of Systemic Inflammation', 'timeFrame': '6 weeks', 'description': 'C reactive protein levels in mg/L using a high-sensitive laboratory test'}, {'measure': 'Interleukin-6 - Marker of Systemic Inflammation', 'timeFrame': '6 weeks', 'description': 'Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay'}, {'measure': 'Interleukin-8 - Marker of Systemic Inflammation', 'timeFrame': '6 weeks', 'description': 'Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay'}], 'secondaryOutcomes': [{'measure': 'Skeletal Muscle Mass', 'timeFrame': '6 weeks', 'description': 'Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment.'}, {'measure': 'Energy Intake', 'timeFrame': '6 weeks', 'description': 'Energy intake in kcal/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics'}, {'measure': 'Protein Intake', 'timeFrame': '6 weeks', 'description': 'Protein intake in g/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics'}, {'measure': 'Handgrip Strength - a Measure of Muscle Strength', 'timeFrame': '6 weeks', 'description': 'Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Haemodialysis', 'Systemic inflammation', 'Skeletal muscle mass', 'Immuno-nutrition'], 'conditions': ['Chronic Kidney Disease Requiring Chronic Dialysis']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to test if an "immuno-nutrition" supplement can decrease inflammation in people on haemodialysis. This immuno-nutrition supplement is high in calories and protein like other common nutritional supplements, but also contains a unique combination of ingredients that have been shown to reduce inflammation (a problem which is caused by the body\'s defence \\[immune\\] system communicating that something is wrong) and improve the immune system in people with cancer. The research team hopes that this small study will help with gaining a good understanding of the effect of immuno-nutrition on inflammation in people on haemodialysis, which will guide and allow the research team to do a larger research study in the future.', 'detailedDescription': "Participants will be asked to take one sachet of the immuno-nutrition supplement each day for 6 weeks. The renal dietitian on the research team will provide participants with detailed oral advice on how and when to take the immuno-nutrition supplement.\n\nParticipants will need to complete 3-day food diaries at the beginning, mid-way point and end of the study.\n\nThe research team will measure weight, height, handgrip strength (a measure of muscle strength), body's composition of fat and muscle using a specialist scale, and skin autofluorescence levels (a measure of toxins called advanced glycation end-products).\n\nThe research team will collect the results of routine blood tests. The research team will also collect and store blood samples taken before and after a haemodialysis session to measure some molecules that indicate inflammation.\n\nAll of these measurements and samples will be taken at the start of the study, and after 6 weeks of taking the immuno-nutrition supplement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CRP level \\>5.0 mg/L.\n* At least three haemodialysis sessions per week for ≥3 hours using a biocompatible dialyser.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Treatment with drugs that cause immunosuppression.\n* Non-English speakers or those with special communication needs.\n* Pregnancy, breast feeding or intending pregnancy.\n* Expected survival \\<6 months.\n* Hospitalisation at the time of screening.\n* Known intolerance or allergy to ONS (or isolated ingredients).\n* Pre-dialysis serum potassium \\>5.0 mmol/L.\n* Unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05700851', 'briefTitle': 'Immuno-nutrition Supplementation in Haemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Effect of Immuno-nutrition on Systemic Inflammation in People Receiving Haemodialysis: a Pilot Study', 'orgStudyIdInfo': {'id': '21085'}, 'secondaryIdInfos': [{'id': '309937', 'type': 'OTHER', 'domain': 'IRAS ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Immuno-nutrition', 'description': "Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.\n\nParticipants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.", 'interventionNames': ['Dietary Supplement: Immuno-nutrition supplement']}], 'interventions': [{'name': 'Immuno-nutrition supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Oral Impact®, Nestlé'], 'description': 'Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre.', 'armGroupLabels': ['Immuno-nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DE22 3NE', 'city': 'Derby', 'state': 'Derbyshire', 'country': 'United Kingdom', 'facility': 'Department of Renal Medicine, Royal Derby Hospital', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}], 'overallOfficials': [{'name': 'Maarten Taal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospitals of Derby and Burton NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}