Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 5:37 PM
Study NCT ID:
NCT04499560
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2020-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a Nutrition Supplement on Health Related Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60', 'timeFrame': 'Baseline and day 60', 'description': 'The PSQI is a validated, self reporting instrument assessing sleep. Possible scores range from 0 to 21 with higher scores indicating lower quality sleep. The instrument contains 19 items.'}, {'measure': 'Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60', 'timeFrame': 'Baseline and day 60', 'description': 'The PHQ is a validated, self reporting instrument assessing general wellbeing through sleep, respiratory health, headache, and gastrointestinal symptoms. Possible scores on each item range from 1 to 7 with higher scores indicating greater frequency of symptoms. The instrument contains 14 items.'}, {'measure': 'Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60', 'timeFrame': 'Baseline and day 60', 'description': 'The SRMCA is a validated, self reporting instrument assessing cognitive wellbeing. Possible scores range from 0 to 27 with higher scores indicating greater cognitive wellbeing. The instrument contains 44 items.'}, {'measure': 'Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60.', 'timeFrame': 'Day 60', 'description': 'The Jackson Symptom Score is a validated, self reporting instrument which contains 8 cold and flu symptoms. Scores range from 0 (no symptoms) to 8 (every one of the listed symptoms.)'}, {'measure': 'Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60', 'timeFrame': 'Baseline and Day 60', 'description': 'The PSS is a validated, self reporting instrument assessing perceived stress. Possible scores range from 0 to 40 with higher scores indicating higher stress levels. The instrument contains ten items.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immune health', 'prevention', 'phytonutrients', 'superfoods', 'antioxidant', 'essential oils'], 'conditions': ['Sleep', 'Stress', 'Health, Subjective', 'Inflammation', 'Cognitive Symptom']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.', 'detailedDescription': 'After being informed about the study, participants will provide informed consent and be randomized to one of two groups: intervention or control. Those in the intervention group will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be assessed at baseline, on day 30 and on day 60.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* otherwise healthy\n* adults living in the US\n* is practicing adequate contraception or is abstaining from all activities which could result in pregnancy\n* understands and agrees to comply with study procedures\n* provides informed consent\n\nExclusion Criteria:\n\n* smoker\n* pregnant or may become pregnant\n* currently breastfeeding\n* currently taking antioxidant supplements\n* underlying chronic health conditions\n* COVID-19 diagnosis\n* demonstrated inability to comply with study procedures\n* history of allergy to citrus or berry fruits\n* has participated in an interventional clinical study within 31 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT04499560', 'briefTitle': 'The Effects of a Nutrition Supplement on Health Related Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Nutraceuticals Research Institute'}, 'officialTitle': 'The Effects of a Nutrition Supplement on Health Related Quality of Life', 'orgStudyIdInfo': {'id': '20-7-1100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants consume 2 ounces of the supplement each morning for 60 days.', 'interventionNames': ['Dietary Supplement: Supplement Drink']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants do not make any changes to their health related routines'}], 'interventions': [{'name': 'Supplement Drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Superfoods based nutritional supplement', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Franklin School of Integrative Health Sciences', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}], 'overallOfficials': [{'name': 'Jessie Hawkins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nutraceuticals Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutraceuticals Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Young Living Essential Oils', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Jessie Hawkins, PhD', 'investigatorAffiliation': 'Nutraceuticals Research Institute'}}}}