Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-05 @ 8:50 AM
Study NCT ID:
NCT06492694
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Supplement and Health Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression', 'timeFrame': '6 weeks', 'description': 'Gene expression analysis refers to a genome-wide quantification of methylation. EPIC850k array will be used for methylation analysis. This represents approximately 900,000 gene locations. The main feature performed is a differential methylation analysis to determine what has significantly changed from one time point to another.'}, {'measure': 'Interleukin 6 (pg/mL)', 'timeFrame': '6 weeks', 'description': 'Serum marker for inflammation'}, {'measure': 'High sensitivity C-reactive protein (mg/L)', 'timeFrame': '6 weeks', 'description': 'Serum marker for inflammation and cardiac health'}, {'measure': 'Apolipoprotein B (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Serum marker for cardiovascular disease risk'}, {'measure': 'Total cholesterol (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in lipid panel for efficacy assessment'}, {'measure': 'Triglycerides (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in lipid panel for efficacy assessment'}, {'measure': 'High density lipoprotein (HDL) Cholesterol (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in lipid panel for efficacy assessment'}, {'measure': 'Very Low density lipoprotein (VLDL) Cholesterol (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in lipid panel for efficacy assessment'}, {'measure': 'Low density lipoprotein (LDL) Cholesterol (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in lipid panel for efficacy assessment'}, {'measure': 'Omega-3 blood levels (%)', 'timeFrame': '6 weeks', 'description': 'Assessment of omega-3 fatty acid concentration in blood'}], 'secondaryOutcomes': [{'measure': 'Albumin (g/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Blood urea nitrogen (BUN) (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Creatinine (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Alkaline phosphatase (U/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Alanine transaminase (ALT) (U/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Aspartate aminotransferase (AST) (U/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Calcium (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Carbon Dioxide (mmol/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Chloride (mmol/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Potassium (mmol/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Sodium (mmol/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Total bilirubin (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Total protein (g/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Body mass index (BMI)', 'timeFrame': '6 weeks', 'description': 'Determine whether body mass index is affected by the consumption of the study product.'}, {'measure': 'Blood pressure (mmHg)', 'timeFrame': '6 weeks', 'description': 'Determine whether blood pressure is affected by the consumption of the study product.'}, {'measure': 'Heart rate (BPM)', 'timeFrame': '6 weeks', 'description': 'Determine whether heart rate is affected by the consumption of the study product.'}, {'measure': 'White blood cells (x10E3/uL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Red blood cells (x10E6/uL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Hemoglobin (g/dL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Hematocrit (%)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Mean corpuscular volume (fL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Mean corpuscular hemoglobin (pg)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Mean corpuscular hemoglobin concentration (g/dL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Red cell distribution width (%)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Platelets (x10E3/uL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Neutrophils (%)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Lymphocytes (%)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Monocytes (%)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Eosinophils (%)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Basophils (%)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Neutrophils (Absolute) (x10E3/uL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Lymphocytes (Absolute) (x10E3/uL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Monocytes (Absolute) (x10E3/uL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Basophils (Absolute) (x10E3/uL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Immature granulocytes (%)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Immature granulocytes (Absolute) (x10E3/uL)', 'timeFrame': '6 weeks', 'description': 'Item in complete blood count for safety assessment'}, {'measure': 'Safety/tolerability', 'timeFrame': '6 weeks', 'description': 'This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses.'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7) scale', 'timeFrame': '6 weeks', 'description': 'Self-reported scale for the measurement of anxiety severity'}, {'measure': 'Patient Health Questionnaire (PHQ-8) scale', 'timeFrame': '6 weeks', 'description': 'Self-reported scale for the measurement of depression severity'}, {'measure': 'Leeds Sleep Evaluation Questionnaire (LSEQ) scale', 'timeFrame': '6 weeks', 'description': 'Self-reported scale for the measurement of sleep quality'}, {'measure': 'Short Form-20 (SF-20) scale', 'timeFrame': '6 weeks', 'description': 'Self-reported scale for assessment of subjective quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fish oil', 'Omega-3', 'Gene expression', 'Wild orange essential oil'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn whether fish oil-based supplements can affect gene expression and serum protein markers in healthy volunteers. The main questions it aims to answer are:\n\n1. How does daily ingestion of fish oil supplements affect gene expression, omega-3 levels, and protein markers as measured in blood?\n2. How does daily ingestion of fish oil supplements affect anthropometric measurements?\n3. How does daily ingestion of fish oil supplements affect subjective quality of life and health parameters?\n4. Do fish oil + wild orange essential oil supplements produce different outcomes than fish oil supplements alone?\n5. Is ingesting fish oil supplements daily safe, as measured by laboratory tests and adverse events?\n\nResearchers will compare two types of fish oil supplements. One type contains fish oil and wild orange essential oil as its active ingredients. The other type contains only fish oil as its active ingredient.\n\nParticipants will:\n\n* Be assigned one of the two types of fish oil supplements\n* Take three softgels of their assigned supplement every day for about six weeks\n* Attend two study visits in which they provide blood and urine samples, complete subjective health and quality of life assessments, and undergo anthropometric measurements\n* Complete weekly subjective health assessments from home', 'detailedDescription': 'This randomized, double-blind study will recruit healthy adults to compare gene expression profile, omega-3 levels, and protein markers before and after consumption of fish oil supplements for approximately six weeks. Quality of life will also be assessed using subjective surveys and questionnaires. Safety markers (liver and kidney function, hematology, urinalysis, and adverse events) will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females, 18-64 years old\n\n * Local to Pleasant Grove, Utah, and/or willing to come to the clinical research center for study visits\n * Willing to provide blood and urine samples during study visits\n * Willing and able to consume study product daily for about 6 weeks\n * Willing to track consumption of study product\n * Willing to keep diet, exercise, sleeping, and current non-study supplement use the same throughout the study\n * Willing to avoid alcohol, recreational drugs, and smoking/vaping for the duration of the study (approximately 7 weeks)\n * Willing to wash out of all internally-consumed essential oil and botanical products for at least 2 weeks prior to starting the study and willing to maintain the washout for the duration of the study (about 9 weeks)\n * Willing to receive and respond to regular texts, emails, and/or phone calls from study staff\n * No metabolic disease (BMI\\>35, diagnosis and treatment of hypertension, diabetes, or dyslipidemia)\n * No major diseases under treatment by a doctor (Medical Reviewer's discretion)\n * No pregnancy within the last 60 days or currently breastfeeding (females)\n * No allergy to fish oil, olive oil, or orange essential oil\n * No regular internal consumption of orange essential oil within the last 1 month (regularly is defined as dosing daily for more than 2 consecutive weeks, or dosing more than 2-3 times per week for 4 consecutive weeks)\n * No regular internal consumption of omega-3 or other fish oil supplements within the last 1 month (regularly is defined as dosing daily for more than 2 consecutive weeks, or dosing more than 2-3 times per week for 4 consecutive weeks)\n * No alcohol, recreational drug, or smoking/vaping use in the past 1 month\n * No evidence of medical condition, significant disease or disorder, medication, or surgery within the past 12 months that may, in the judgment of the medical provider, put the participant at risk or affect study results, procedures, or outcomes\n * Not currently or previously participating in any other clinical trial within the last 30 calendar days\n * Signed informed consent, HIPAA Authorization, and Confidentiality Agreement\n\nExclusion Criteria:\n\n* Failure to meet any of the above inclusion criteria"}, 'identificationModule': {'nctId': 'NCT06492694', 'briefTitle': 'Omega-3 Supplement and Health Markers', 'organization': {'class': 'INDUSTRY', 'fullName': 'dōTERRA International'}, 'officialTitle': 'Evaluation of a Fish Oil-based, Essential-oil Infused Supplement on Markers of Health', 'orgStudyIdInfo': {'id': 'DO-124023-OWO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fish oil + wild orange essential oil supplement', 'description': 'Participants in this arm will take three capsules of a fish oil + wild orange essential oil supplement daily for approximately six weeks.', 'interventionNames': ['Dietary Supplement: Fish oil + wild orange essential oil supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fish oil supplement', 'description': 'Participants in this arm will take three capsules of a fish oil essential oil supplement daily for approximately six weeks.', 'interventionNames': ['Dietary Supplement: Fish oil supplement']}], 'interventions': [{'name': 'Fish oil + wild orange essential oil supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This supplement contains fish oil and wild orange essential oil as its active ingredients.', 'armGroupLabels': ['Fish oil + wild orange essential oil supplement']}, {'name': 'Fish oil supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This supplement contains fish oil as its active ingredient.', 'armGroupLabels': ['Fish oil supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84062', 'city': 'Pleasant Grove', 'state': 'Utah', 'country': 'United States', 'facility': 'doTERRA International', 'geoPoint': {'lat': 40.36412, 'lon': -111.73854}}], 'overallOfficials': [{'name': 'Nicole Stevens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'doTERRA International'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'dōTERRA International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}