Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT05609006
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2022-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance rate with ONS', 'timeFrame': 'One period of 28 days for both ONS (high-energy low-volume, and high-energy standard)', 'description': 'Percentage of consumed energy over the prescribed'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal tolerance', 'timeFrame': 'Weekly (from second to fourth week of each period) up to 8 weeks', 'description': 'Tolerance is measured using a numeric rate scale (NRS) of the frequency of symptoms (0, not at all; 10, very frequently) for the last 7 days such as nausea, vomiting, diarrhea, constipation, acid reflux, bellyache, bloated belly, stomach pain, flatulence, and satiety.'}, {'measure': 'Satisfaction with ONS', 'timeFrame': 'For each period/ONS, up to 8 weeks', 'description': 'Satisfaction with the ONS taste, satiety, ease of completing the intake, and overall satisfaction are measured using an NRS of the level of satisfaction (0, very dissatisfied; 10, very satisfied).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the compliance of high-energy, low-volume oral nutritional supplements (ONS) compared to equivalent high-energy standard ONS (control) in participants at risk of malnutrition.', 'detailedDescription': "The use of high-calorie, high-protein ONS is recommended in patients with malnutrition or who are at risk of malnutrition-related disease. However, compliance with ONS is a key feature to improve the patient's nutritional status. Since compliance with ONS could be influenced by the energy density and the volume of the nutritional supplement used, a higher energy density and lower volume ONS could provide similar energy to the standard ONS for the requirements of this population.\n\nThis study has been designed as an open-label randomized crossover study with nutritional intervention with the aim to compare the patient's compliance, defined as the percentage of energy consumed with respect to that prescribed, with a high-energy content, low volume ONS versus a standard high calorie and volume ONS, over an 8-weeks follow-up period. As secondary objectives, the study aims to describe the gastrointestinal tolerance and satisfaction of the study ONS, to establish the factors that may affect compliance with the ONS and to compare the cost associated with product wastage in both ONS.\n\nThe study population will consist of patients aged ≥ 18 years, distributed into three groups according to their diagnosis: oncological patients, surgical patients, and other patients, all of them malnourished or at risk of malnutrition according to Subjective Global Assessment (SGA), and requiring the use of an ONS. Participants will be randomly allocated to receive either:\n\nGroup A: A high energy, low volume ONS (2.4kcal/ml; 125ml) in addition to the diet for 28 days. Participants will then receive the equivalent standard ONS (2.0kcal/ml, 200ml) as control ad libitum in addition to diet for 7 days, or:\n\nGroup B. A standard ONS (2.0 kcal/ml, 200ml) as control in addition to the diet for 28 days. Participants will then receive the high energy, low volume equivalent ONS (2.4kcal/ml; 125ml) for 28 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥ 18 years\n* Patients who are in one of the following clinical situations: oncological patients who did not undergo surgery during the month prior to inclusion, including head and neck, esophagus, stomach, pancreas, or colon cancer; surgical patients who underwent surgery less than one month, including all types of surgical processes; and other non-surgical patients diagnosed with benign esophageal stricture, chronic radiation enteritis, and non-oncological maxillofacial pathology, cystic fibrosis, human immunodeficiency virus (HIV), malabsorption syndrome , ulcerative colitis, Crohn's disease, fistula, intestinal pseudo-obstruction, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), or who were undergone to scheduled major surgery or transplantation within a period of no less than 2 months until inclusion.\n* Patients with malnutrition or at risk of malnutrition according to Subjective Global Assessment (SGA).\n* Patients with a high energy requirement that require 2 bottles/day of an ONS (≥2kcal/ml), for a minimum period of 8 weeks\n* Patients who have not received ONS during the month prior to their inclusion. Surgical patients may have received ONS prior to the study in accordance with the guidelines of the institution.\n* Patients who voluntarily agree to participate in the study and give their signed consent for participation.\n\nExclusion Criteria:\n\n* Patients suffering from any of the following clinical disorders: chronic kidney insufficiency or diabetes.\n* Patients requiring enteral tube feeding or parenteral nutrition.\n* Patients suffering from an allergy or intolerance to the product ingredients.\n* Patients scheduled for surgery during the study period.\n* Patients who, in the opinion of the treating physician, are unable to adhere to the protocol instructions, including inability of the patient/caregiver to use the study eCRF, and to remain in the study during all the follow-up."}, 'identificationModule': {'nctId': 'NCT05609006', 'briefTitle': 'Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Specialized Nutrition'}, 'officialTitle': 'Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement (ONS)', 'orgStudyIdInfo': {'id': 'NUT 2.4 Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS', 'description': 'Intervention: high-energy low-volume ONS (2.4kcal/ml; 125ml) for 28 days followed by high-energy standard ONS (2.0kcal/ml; 200ml) for 28 days', 'interventionNames': ['Dietary Supplement: High-Energy, Low-Volume ONS', 'Dietary Supplement: High-Energy Standard ONS']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS', 'description': 'Intervention: high-energy standard ONS (2.0kcal/ml; 200ml) for 28 days followed by high-energy low-volume ONS (2.4kcal/ml; 125ml) for 28 days', 'interventionNames': ['Dietary Supplement: High-Energy, Low-Volume ONS', 'Dietary Supplement: High-Energy Standard ONS']}], 'interventions': [{'name': 'High-Energy, Low-Volume ONS', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Energy-dense ONS', '2.4 ONS'], 'description': '2 bottles/day of a High-Energy, Low-Volume ONS', 'armGroupLabels': ['Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS', 'Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS']}, {'name': 'High-Energy Standard ONS', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['2.0 ONS'], 'description': '2 bottles/day of a High-Energy Standard ONS', 'armGroupLabels': ['Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS', 'Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29001', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Miguel Leon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario 12 de Octubre'}, {'name': 'Gabriel Olveira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Regional de Malaga'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Specialized Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}