Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-28 @ 4:22 AM
Study NCT ID:
NCT04656860
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2020-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Juice Plus Supplement Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Both the investigator and the participants will be blinded to study conditions'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to experimental or placebo controlled condition'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2023-03-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2020-04-03', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Interleukin -5', 'timeFrame': 'Baseline, Year, 1, and Year 2.', 'description': 'Interleukin -5 pg/mL'}, {'measure': 'Change in serum Amyloid A', 'timeFrame': 'Baseline, Year, 1, and Year 2.', 'description': 'Serum Amyloid A pg/mL'}, {'measure': 'Change in Interleukin 6', 'timeFrame': 'Baseline, Year, 1, and Year 2.', 'description': 'Interleukin 6 pg/mL'}, {'measure': 'Change in C-reactive protein', 'timeFrame': 'Baseline, Year, 1, and Year 2.', 'description': 'C-reactive protein pg/mL'}], 'secondaryOutcomes': [{'measure': 'Auditory Very Learning Test', 'timeFrame': 'Baseline, 6-months, 12-months, 18-months, and 24-months', 'description': 'Computer automated verbal memory recognition task'}, {'measure': 'Stroop Test', 'timeFrame': 'Baseline, 6-months, 12-months, 18-months, and 24-months', 'description': 'Verbal interference'}, {'measure': 'Trial Making task', 'timeFrame': 'Baseline, 6-months, 12-months, 18-months, and 24-months', 'description': 'Information processing speed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fruits and Vegetables', 'Inflammation', 'Cognition'], 'conditions': ['Cognitive Impairment', 'Alzheimer Disease, Early Onset', 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'The study is designed to determine whether encapsulated fruit and vegetable juice concentrates can improve biological indicators of cognitive and multiple dimensions of memory and learning.', 'detailedDescription': "Preventive interventions that delay the onset of mild cognitive impairment and benign forgetfulness have the potential to delay or even prevent the onset of Alzheimer's disease. However, few studies have examined the feasibility of Encapsulated Fruit and Vegetable Juice Concentrates in robust clinical trials; this limitation prevents investigators from determining the real value of these supplements. Therefore, we propose to enroll 150 adults aged 55 and older to a 24-month randomized placebo-controlled trial. Participants enrolled in the experimental condition will be encouraged to consume 6 Encapsulated Fruit and Vegetable Juice Concentrates capsules per day and 33 grams of a soy-based beverage power per day, which included 5 grams of fiber. Participants enrolled in the controlled condition will receive six placebo capsules and encouraged to maintain an adequate diet. Primary outcomes will include objective measures of cognition, and a panel of inflammatory markers, peptides, enzymes, and other biological markers known to be associated with cognitive decline."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Men and women ≥55 years old will be eligible participants\n\nExclusion Criteria:\n\n* Prior neurological or psychiatric condition\n* Using medications or supplements that influence cognition or inflammation (e.g., nootropics, asprin, and Nonsteroidal anti-inflammatory drugs,),\n* Prior cancer diagnosis,\n* Major respiratory, kidney, liver, and gastrointestinal issues\n* Currently enrolled in a weight loss program or taking an appetite suppressant;\n* Current smokers or excessive alcohol users\n* Consume \\>= 4 servings of fruits and vegetables per day\n\n * Participate in \\>= 90 minutes of purposeful physical activity per week\n * Do not have a mobile phone\n * Do not have a data plan or regular wireless network'}, 'identificationModule': {'nctId': 'NCT04656860', 'briefTitle': 'Juice Plus Supplement Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama, Tuscaloosa'}, 'officialTitle': 'Encapsulated Fruit and Vegetable Juice Concentrates, Cognition, and Inflammation - A Randomized Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '17-19-490'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Juice Plus+', 'description': 'Participants will consume 6 capsules daily consisting of a combination of Juice Plus+ Garden Blend, Juice Plus+ Orchard Blend and Juice Plus+ Berry Blend. Participants will consume supplements for 24-months.', 'interventionNames': ['Dietary Supplement: Juice Plus+']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will consume 6 capsules daily consisting of microcrystalline cellulose, rice starch, vegetarian capsule (cellulose), and magnesium stearate. Participants in this condition will receive 1-year of supplements after the study is completed.', 'interventionNames': ['Dietary Supplement: Juice Plus+']}], 'interventions': [{'name': 'Juice Plus+', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period', 'armGroupLabels': ['Juice Plus+', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35487', 'city': 'Tuscaloosa', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raheem Paxton, PhD', 'role': 'CONTACT', 'email': 'rpaxton@ua.edu', 'phone': '205-348-6857'}], 'facility': 'University of Alabama, North East Medical Building', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '35487', 'city': 'Tuscaloosa', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raheem Paxton, PhD', 'role': 'CONTACT', 'email': 'rpaxton@ua.edu', 'phone': '205-348-6857'}, {'name': 'Raheem Paxton, PhD', 'role': 'CONTACT', 'email': 'rpaxton@ua.edu', 'phone': '204-348-6857'}], 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}], 'centralContacts': [{'name': 'Raheem Paxton, PhD', 'role': 'CONTACT', 'email': 'rpaxton@ua.edu', 'phone': '205-348-6857'}], 'overallOfficials': [{'name': 'Raheem Paxton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual data will not be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama, Tuscaloosa', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Texas Health Science Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}