Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-03-06 @ 10:57 AM
Study NCT ID:
NCT03736551
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Study outcome measures performed by assessor blinded to treatment arm'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel arm, single blinded, randomised controlled feasibility study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-04', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention rate of at least 60% in the intervention group', 'timeFrame': '6 months', 'description': 'Patients attending at least 80% of monthly clinic visits, including the baseline and final study visits, and remaining compliant with the 2 consecutive days VLED throughout the 6 month intervention will be considered "completers" and count as being retained in the intervention group at 6 months.'}, {'measure': 'Number of Adverse Events following intermittent very low energy diet', 'timeFrame': '6 months', 'description': 'record of all adverse events including but not limited to nausea, constipation and/or diarrhoea, dehydration, hypoglycaemia, lethargy \\& fatigue, headaches, gallstones and gout.'}], 'secondaryOutcomes': [{'measure': 'Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria', 'timeFrame': '1 year', 'description': 'at least 50% of those meeting the referral criteria and are approached to participant, consent to participating in the study'}, {'measure': 'Compliance with dietary intervention from dietary records', 'timeFrame': '6 months', 'description': 'at least 70% compliance with prescribed diet'}, {'measure': 'Weight change (kg)', 'timeFrame': '6 months', 'description': 'change in weight from baseline to 6 months'}, {'measure': 'kidney function (eGFR ml/min CKD EPI equation)', 'timeFrame': '6 months', 'description': 'monitoring if estimated kidney function declines during the study or if symptomatic for dehydration.'}, {'measure': 'Waist circumference (cm)', 'timeFrame': '6 months', 'description': 'change in waist circumference measured in cm at level of umbilicus'}, {'measure': 'Body composition', 'timeFrame': '6 months', 'description': 'lean and fat mass (kg) estimated by bioelectrical impedance analysis'}, {'measure': 'Exercise capacity - 6 minute timed walk test', 'timeFrame': '6 months', 'description': 'distance walked (m) in 6 minutes'}, {'measure': 'Exercise capacity - sit to stand 60', 'timeFrame': '6 months', 'description': 'number (count) of sit to stand movements in 60 seconds'}, {'measure': 'Proteinuria', 'timeFrame': '6 months', 'description': 'urinary protein to creatinine ratio'}, {'measure': 'Total Cholesterol', 'timeFrame': '6 months', 'description': 'plasma total cholesterol concentration'}, {'measure': 'Triglycerides', 'timeFrame': '6 months', 'description': 'plasma triglycerides concentration'}, {'measure': 'LDL cholesterol', 'timeFrame': '6 months', 'description': 'plasma LDL cholesterol concentration'}, {'measure': 'HDL cholesterol', 'timeFrame': '6 months', 'description': 'plasma HDL cholesterol concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intermittent fasting', 'weight loss'], 'conditions': ['Chronic Kidney Diseases', 'Obesity']}, 'descriptionModule': {'briefSummary': "This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2 diet) plus exercise, compared with the investigator's established Weight Management Programme (WMP), in obese patients with CKD, using feasibility study methodology.\n\nPatients will be invited to participate in the parallel arm, single blinded, randomised controlled feasibility study, and randomly allocated to 1 of 2 treatments for 6 months. The experimental arm involves an intermittent modified fasting regimen consisting of VLED (600 kcal/day) on 2 consecutive days, and 5 days each week on a modified diet to maintain an overall energy deficit of 600 kcal/day across the week (5:2 diet). The control arm will be the standard renal WMP with a continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day.\n\nThe feasibility outcomes are: recruitment rate \\>50%; intervention retention rate at 6 months \\>60%; dietary intervention compliance; and weight loss. Secondary outcomes include safety, body composition, proteinuria, lipids, blood pressure, and eating desire. Measurements will be made at baseline, midpoint, and twice at endpoint."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-75 years\n* KDIGO defined CKD (all categories)\n* BMI ≥30kg/m2\n* able to provide written informed consent in English\n\nExclusion Criteria:\n\n* pregnant or breastfeeding women\n* conservatively managed CKD stage 5\n* palliative or active treatment for cancer\n* unstable chronic liver disease\n* type 1 diabetes and type 2 diabetes controlled with anti-hyperglycaemic medication\n* previous bariatric surgery\n* unable to provide written informed consent\n* significant psychiatric disorder or uncontrolled depression\n* participated in a weight management drug trial in the previous 3 months\n* uncontrolled epilepsy\n* alcohol or substance abuse'}, 'identificationModule': {'nctId': 'NCT03736551', 'acronym': 'MIX-UP', 'briefTitle': 'Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'Model of Intermittent Very Low Energy Diet and eXercise for Lowering BMI in Patients With CKD (MIX UP): Feasibility Study', 'orgStudyIdInfo': {'id': 'KCH17-027'}, 'secondaryIdInfos': [{'id': '202350', 'type': 'REGISTRY', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention arm will involve standard care plus an intermittent modified fasting regimen consisting of a very low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet). All dietary intake on modified fasting days will be from LighterLife foodpacks, (4 x 150 kcal portions/day presented as milkshakes, cereal bars, soups and modified meals such as spaghetti bolognese, or macaroni cheese) providing \\~600 kcal/day and 100% of the RNI for vitamins and minerals.', 'interventionNames': ['Behavioral: 5:2 diet', 'Behavioral: Renal Weight Management Programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'Renal Weight management Programme - Patients will attend individual appointments with the specialist dietitian and physiotherapist once a month, for 6 months. Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure (9). In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing.', 'interventionNames': ['Behavioral: Renal Weight Management Programme']}], 'interventions': [{'name': '5:2 diet', 'type': 'BEHAVIORAL', 'description': 'very low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet)', 'armGroupLabels': ['Intervention']}, {'name': 'Renal Weight Management Programme', 'type': 'BEHAVIORAL', 'description': 'Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure. In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing.', 'armGroupLabels': ['Intervention', 'Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Helen L MacLaughlin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Fundation Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}