Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-28 @ 10:23 AM
Study NCT ID:
NCT04378556
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2020-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Dietary Protein Intake in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Repeated measures design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Protein intake', 'timeFrame': 'Change from baseline to 10 weeks', 'description': 'Protein intake (g/kg/body weight) per day'}], 'secondaryOutcomes': [{'measure': 'Change in Grip strength', 'timeFrame': 'Change from baseline to 10 weeks', 'description': 'Grip strength measured using dynamometer'}, {'measure': 'Change in Timed Up and Go Test', 'timeFrame': 'Change from baseline to 10 weeks', 'description': 'The timed up and go test measures the time (in seconds) that it takes to stand up from a seated position in a chair, walk 3 meters away from the chair at a comfortable pace to a line on the floor, turn around, walk back, and sit back down in the chair.'}, {'measure': 'Change in 3 meter walk', 'timeFrame': 'Change from baseline to 10 weeks', 'description': 'The 3-meter walk test measures the time (in seconds) that it takes to stand up from a seated position in a chair and walk 3 meters away from the chair at a comfortable pace to a line on the floor'}, {'measure': 'Change in 5-Chair Rise Stand Test', 'timeFrame': 'Change from baseline to 10 weeks', 'description': 'The 5 chair rise stand test requires participants to stand up 5 times without hand assistance from a straight back chair without an armrest. The time required to complete the 5 chair rises is recorded.'}, {'measure': 'Change in Short Performance Physical Battery Score', 'timeFrame': 'Change from baseline to 10 weeks', 'description': 'The Short Physical Performance Battery (SPPB) consists of timed measures of balance, 3-meter walk, and 5-chair rises. The balance portion requires participants to stand with feet next to each other, the toes of one foot next to the heel of the other foot, and heel to toe for a 10 second duration. Scores are assigned based on the number of seconds the participant can stand in the position for balance. Scores for the chair rise and 3 meter walk are based on the time taken to complete the task. The scores are totaled to arrive at the Short Performance Physical Battery Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Protein intake', 'Coaching', 'Strength'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A pilot, single-arm investigation used coaching, nutrition education, and a per-meal protein prescription to assess impact on protein intake, muscle strength and function in older adults.', 'detailedDescription': 'Objective: To evaluate the effects of nutrition education, diet coaching, and a protein prescription (PP) on protein intake, and associations with muscle strength and function. Design: Prospective pretest posttest single-arm study. Setting: Urban area, East coast of South Florida. Participants: Older adults. Intervention: 10-week telephone-based diet coaching, nutrition education and a per-meal PP. Measurements: Protein and energy intakes, weight, grip strength (GS), and 5-chair-rise (5CR), timed up and go (TUG), 3-meter walk (3mW) tests at baseline and 10 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 55 years or older,\n* Community-dwelling (living independently),\n* Able to provide consent,\n* Able to understand and respond to questions or instructions in English,\n* Have a working telephone (for coaching sessions),\n* Willingness to consume protein-containing animal products\n* Willingness to make changes to the diet\n\nExclusion Criteria:\n\n* Self-reported information that they have been told by a medical doctor that they have kidney (renal) disease.\n* Vegan dietary practices,\n* Refusal to make changes to usual dietary protein intake, or a usual dietary protein intake that meets recommendations.'}, 'identificationModule': {'nctId': 'NCT04378556', 'briefTitle': 'Improving Dietary Protein Intake in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Florida Atlantic University'}, 'officialTitle': 'Improving Dietary Protein Intake in Adults', 'orgStudyIdInfo': {'id': '1151456-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nutrition', 'description': 'All participants received diet coaching, nutrition education and a per-meal protein prescription.', 'interventionNames': ['Behavioral: Nutritional coaching']}], 'interventions': [{'name': 'Nutritional coaching', 'type': 'BEHAVIORAL', 'description': 'Participants were provided with nutrition education and a per-meal protein prescription followed by 9 weeks of nutritional coaching.', 'armGroupLabels': ['Nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Atlantic University', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Atlantic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}