Omega-3 Supplement and Health Markers
NCT Number: NCT06492694
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: Fish oil + wild orange essential oil supplement|DIETARY_SUPPLEMENT: Fish oil supplement
Sponsor: dōTERRA International
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-06-10
Completion Date: 2024-08-26
Locations: doTERRA International, Pleasant Grove, Utah, 84062, United States

Summary:
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:

1. How does daily ingestion of fish oil supplements affect gene expression, omega-3 levels, and protein markers as measured in blood?
2. How does daily ingestion of fish oil supplements affect anthropometric measurements?
3. How does daily ingestion of fish oil supplements affect subjective quality of life and health parameters?
4. Do fish oil + wild orange essential oil supplements produce different outcomes than fish oil supplements alone?
5. Is ingesting fish oil supplements daily safe, as measured by laboratory tests and adverse events?

Researchers 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.

Participants will:

* Be assigned one of the two types of fish oil supplements
* Take three softgels of their assigned supplement every day for about six weeks
* Attend two study visits in which they provide blood and urine samples, complete subjective health and quality of life assessments, and undergo anthropometric measurements
* Complete weekly subjective health assessments from home

Primary Outcome Measures: Gene expression, 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., 6 weeks|Interleukin 6 (pg/mL), Serum marker for inflammation, 6 weeks|High sensitivity C-reactive protein (mg/L), Serum marker for inflammation and cardiac health, 6 weeks|Apolipoprotein B (mg/dL), Serum marker for cardiovascular disease risk, 6 weeks|Total cholesterol (mg/dL), Item in lipid panel for efficacy assessment, 6 weeks|Triglycerides (mg/dL), Item in lipid panel for efficacy assessment, 6 weeks|High density lipoprotein (HDL) Cholesterol (mg/dL), Item in lipid panel for efficacy assessment, 6 weeks|Very Low density lipoprotein (VLDL) Cholesterol (mg/dL), Item in lipid panel for efficacy assessment, 6 weeks|Low density lipoprotein (LDL) Cholesterol (mg/dL), Item in lipid panel for efficacy assessment, 6 weeks|Omega-3 blood levels (%), Assessment of omega-3 fatty acid concentration in blood, 6 weeks
Secondary Outcome Measures: Albumin (g/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Blood urea nitrogen (BUN) (mg/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Creatinine (mg/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Alkaline phosphatase (U/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Alanine transaminase (ALT) (U/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Aspartate aminotransferase (AST) (U/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Calcium (mg/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Carbon Dioxide (mmol/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Chloride (mmol/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Potassium (mmol/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Sodium (mmol/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Total bilirubin (mg/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Total protein (g/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Body mass index (BMI), Determine whether body mass index is affected by the consumption of the study product., 6 weeks|Blood pressure (mmHg), Determine whether blood pressure is affected by the consumption of the study product., 6 weeks|Heart rate (BPM), Determine whether heart rate is affected by the consumption of the study product., 6 weeks|White blood cells (x10E3/uL), Item in complete blood count for safety assessment, 6 weeks|Red blood cells (x10E6/uL), Item in complete blood count for safety assessment, 6 weeks|Hemoglobin (g/dL), Item in complete blood count for safety assessment, 6 weeks|Hematocrit (%), Item in complete blood count for safety assessment, 6 weeks|Mean corpuscular volume (fL), Item in complete blood count for safety assessment, 6 weeks|Mean corpuscular hemoglobin (pg), Item in complete blood count for safety assessment, 6 weeks|Mean corpuscular hemoglobin concentration (g/dL), Item in complete blood count for safety assessment, 6 weeks|Red cell distribution width (%), Item in complete blood count for safety assessment, 6 weeks|Platelets (x10E3/uL), Item in complete blood count for safety assessment, 6 weeks|Neutrophils (%), Item in complete blood count for safety assessment, 6 weeks|Lymphocytes (%), Item in complete blood count for safety assessment, 6 weeks|Monocytes (%), Item in complete blood count for safety assessment, 6 weeks|Eosinophils (%), Item in complete blood count for safety assessment, 6 weeks|Basophils (%), Item in complete blood count for safety assessment, 6 weeks|Neutrophils (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 6 weeks|Lymphocytes (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 6 weeks|Monocytes (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 6 weeks|Basophils (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 6 weeks|Immature granulocytes (%), Item in complete blood count for safety assessment, 6 weeks|Immature granulocytes (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 6 weeks|Safety/tolerability, This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses., 6 weeks|Generalized Anxiety Disorder-7 (GAD-7) scale, Self-reported scale for the measurement of anxiety severity, 6 weeks|Patient Health Questionnaire (PHQ-8) scale, Self-reported scale for the measurement of depression severity, 6 weeks|Leeds Sleep Evaluation Questionnaire (LSEQ) scale, Self-reported scale for the measurement of sleep quality, 6 weeks|Short Form-20 (SF-20) scale, Self-reported scale for assessment of subjective quality of life, 6 weeks