Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:39 PM
Study NCT ID:
NCT07422935
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plant-Protein Dominant Tube Feed Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Exploratory, randomised, controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gastrointestinal tolerance', 'timeFrame': 'Change from baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)', 'description': 'A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea).'}, {'measure': 'Acceptability', 'timeFrame': 'Baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)', 'description': 'Acceptability (e.g., liking, ease of use, preference) will be assessed by a questionnaire. Questions will be rated on a 7-point Likert scale (1 strongly disagree - 7 strongly agree)'}, {'measure': 'Compliance', 'timeFrame': 'Baseline to end of intervention (93 days) and end of follow-up (12 months)', 'description': 'Compliance with the study product prescription (%) will be assessed daily by recording how much of the study product was prescribed compared to the amount administered.'}, {'measure': 'Nutritional intake', 'timeFrame': 'Baseline to end of intervention (Day 93) and end of follow-up (12 months)', 'description': 'A 24-h dietary recall will be conducted to record all food, drink and nutritional feeds taken in the 24 hours prior for analysis of daily nutritional intake i.e., total energy intake (kcal/day) and macro- and micronutrients (g/day or mg/day).'}, {'measure': 'Body weight', 'timeFrame': 'Baseline to end of intervention (Day 93) and end of follow-up (12 months)', 'description': 'Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height and weight measures will be used to calculate body mass index (BMI) as kg/m\\^2.'}, {'measure': 'Height', 'timeFrame': 'Baseline to end of intervention (Day 93) and end of follow-up (12 months)', 'description': 'Height will be measured at baseline only using standard measures to the nearest 0.1cm, without shoes or socks. Height and weight measures will be used to calculate body mass index (BMI) as kg/m\\^2.'}, {'measure': 'Calf circumference', 'timeFrame': 'Baseline to end of intervention (Day 93) and end of follow-up (12 months)', 'description': 'Calf circumference will be measured using standard measures to the nearest 0.1cm'}, {'measure': '30-s Chair Stand Test', 'timeFrame': 'Baseline to end of intervention (Day93) and end of follow-up (12 months)', 'description': 'Number of times patients can stand up and sit down from a chair within 30 seconds.'}, {'measure': 'Handgrip strength', 'timeFrame': 'Baseline to end of intervention (Day93) and end of follow-up (12 months)', 'description': 'A novel dynamometer will be used to assess muscle strength (kg) via a maximal grip strength test'}, {'measure': 'Hand Grip Fatiguability', 'timeFrame': 'Baseline to end of intervention (Day93) and end of follow-up (12 months)', 'description': 'Muscle fatigability (in seconds) will be measured using a fatigue resistance test on a novel hand grip dynamometer'}, {'measure': 'Capacity to Perceived Vitality (CPV) ratio', 'timeFrame': 'Baseline to end of intervention (Day93) and end of follow-up (12 months)', 'description': 'Vitality capacity, measured as Capacity to Perceived Vitality (CPV) ratio will be calculated using fatiguability, measured with a novel hand grip dynamometer combined, combined with the score from a validated questionnaire'}, {'measure': 'Sarc-CalF tool', 'timeFrame': 'Baseline to end of intervention (Day93) and end of follow-up (12 months)', 'description': 'Sarcopenia screening tool consisting of a 5 question questionnaire combined with calf circumference measurement. A score ≥ 11 points is suggestive of sarcopenia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enteral Nutrition (Food for Special Medical Purposes)', 'Enteral Feeds']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether a reformulated plant-protein dominant protein blend in four existing enteral tube feeds is as effective as animal-protein dominant formulations in patients who are tube fed at home. This is an exploratory randomised, controlled, trial with a 3-day baseline period. Adult home tube feeding patients will be randomised to receive either a plant-protein dominant formulation or a control product (an animal-protein dominant formulation) for a 3-month intervention period followed by a 6-month and 12-month follow-up. The outcomes include gastrointestinal tolerance, compliance, acceptability, anthropometry, nutrient intake, and physical function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n\n -≥16 years of age\n* Using or requiring an enteral tube feed in the community as part of nutritional management plan\n* Expected to receive at least 500ml (≥500kcal) per day from one of the study products\n\nExclusion Criteria:\n\n* Receiving parenteral nutrition\n* Patients with major hepatic dysfunction (i.e., decompensated liver disease)\n* Patients with major renal dysfunction (i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD))\n* Patients receiving inpatient care\n* Known pregnancy or lactation\n* Participation in other clinical intervention studies within 1 month of this study\n* Allergy to any study product ingredients\n* Investigator concern regarding ability or willingness of patient to comply with the study requirements.'}, 'identificationModule': {'nctId': 'NCT07422935', 'briefTitle': 'Plant-Protein Dominant Tube Feed Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia UK Ltd'}, 'officialTitle': 'Exploratory Randomised, Controlled Trial To Evaluate The Impact Of Four Nutritionally Complete, Plant-Protein Dominant, Enteral Tube Feeds On Long Term Outcomes In Community-Based Adults', 'orgStudyIdInfo': {'id': 'PPD2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plant-Protein Dominant Intervention', 'description': 'During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the plant-protein dominant feeds.', 'interventionNames': ['Dietary Supplement: Plant-protein dominant enteral feed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Animal-Protein Dominant Control', 'description': 'During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the animal-protein dominant feed (control) daily.', 'interventionNames': ['Dietary Supplement: Animal-protein dominant enteral feed']}], 'interventions': [{'name': 'Plant-protein dominant enteral feed', 'type': 'DIETARY_SUPPLEMENT', 'description': "Patients randomised to the Intervention Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 plant-protein dominant enteral feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).", 'armGroupLabels': ['Plant-Protein Dominant Intervention']}, {'name': 'Animal-protein dominant enteral feed', 'type': 'DIETARY_SUPPLEMENT', 'description': "Patients randomised to the Control Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 animal-protein dominant control feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).", 'armGroupLabels': ['Animal-Protein Dominant Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA14 0XQ', 'city': 'Trowbridge', 'state': 'Wiltshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Nutricia Ltd', 'geoPoint': {'lat': 51.31889, 'lon': -2.20861}}], 'centralContacts': [{'name': 'Sophie Bell', 'role': 'CONTACT', 'email': 'sophie.bell@nutricia.com', 'phone': '+7717498628'}, {'name': 'Ellen Taylor', 'role': 'CONTACT', 'email': 'ellen.taylor@nutricia.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia UK Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospitals Coventry and Warwickshire NHS Trust', 'class': 'OTHER'}, {'name': 'Gateshead Health NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'University Hospitals of Derby and Burton NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Bradford Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER_GOV'}, {'name': 'University College London Hospitals', 'class': 'OTHER'}, {'name': 'South Warwickshire NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Birmingham Community Healthcare NHS', 'class': 'OTHER_GOV'}, {'name': 'University Hospital Birmingham', 'class': 'OTHER'}, {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}