Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT02683720
Status:
UNKNOWN
Last Update Posted:
2016-07-21
First Post:
2016-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-20', 'studyFirstSubmitDate': '2016-02-12', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lean body mass', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'body weight', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malnutrition', 'Muscle Health']}, 'referencesModule': {'references': [{'pmid': '33799307', 'type': 'DERIVED', 'citation': 'Grootswagers P, Smeets E, Oteng AB, Groot L. A novel oral nutritional supplement improves gait speed and mitochondrial functioning compared to standard care in older adults with (or at risk of) undernutrition: results from a randomized controlled trial. Aging (Albany NY). 2021 Apr 2;13(7):9398-9418. doi: 10.18632/aging.202912. Epub 2021 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 65+\n* at risk of malnutrition/ malnourished\n\nExclusion Criteria:\n\n* • Mental status that is incompatible with the proper conduct of the study\n\n * Illness of such severity that life expectancy is considered to be less than 12 months\n * Use of diabetes medication (e.g. insulin, methformin)\n * Use of an oral nutritional supplement in the previous three months\n * Participating in any regular exercise training program (≥2h/w)\n * Renal insufficiency (eGFR \\<30 mL/min/1.73 m2)\n * Unstable organ failure or organ failure necessitating a special diet\n * Chronic corticosteroids use\n * Recent (previous 2 months) use of antibiotics\n * Recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin)\n * Recent blood donation (\\<1 month prior to Day 01 of the study)\n * Not willing or afraid to give blood during the study\n * Allergic or sensitive for milk proteins\n * Reported vegan or macrobiotic life-style\n * Drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week)\n * Individual unable to give informed consent\n * Current participation in other research from the Division of Human Nutrition\n * Not having a general practitioner\n * Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives'}, 'identificationModule': {'nctId': 'NCT02683720', 'acronym': 'ProMO', 'briefTitle': 'Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly', 'orgStudyIdInfo': {'id': 'NL56873.081.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONS1', 'description': 'new product', 'interventionNames': ['Dietary Supplement: ONS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ONS2', 'description': 'usual care', 'interventionNames': ['Dietary Supplement: ONS']}], 'interventions': [{'name': 'ONS', 'type': 'DIETARY_SUPPLEMENT', 'description': 'randomized clinical trial involving different ONS strategies', 'armGroupLabels': ['ONS1', 'ONS2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wageningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Pol Grootswagers, Msc', 'role': 'CONTACT', 'email': 'pol.grootswagers@wur.nl'}, {'name': 'Lisette de Groot, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pol Grootswagers, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Wageningen University', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vitalnext', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc PhD Prof', 'investigatorFullName': 'Lisette de Groot', 'investigatorAffiliation': 'Wageningen University'}}}}