Omega-3 Supplement and Health Markers
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Fish oil + wild orange essential oil supplementDietary Supplement: Fish oil supplement
- Registration Number
- NCT06492694
- Lead Sponsor
- dÅTERRA International
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
-
Males and females, 18-64 years old
- Local to Pleasant Grove, Utah, and/or willing to come to the clinical research center for study visits
- Willing to provide blood and urine samples during study visits
- Willing and able to consume study product daily for about 6 weeks
- Willing to track consumption of study product
- Willing to keep diet, exercise, sleeping, and current non-study supplement use the same throughout the study
- Willing to avoid alcohol, recreational drugs, and smoking/vaping for the duration of the study (approximately 7 weeks)
- 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)
- Willing to receive and respond to regular texts, emails, and/or phone calls from study staff
- No metabolic disease (BMI>35, diagnosis and treatment of hypertension, diabetes, or dyslipidemia)
- No major diseases under treatment by a doctor (Medical Reviewer's discretion)
- No pregnancy within the last 60 days or currently breastfeeding (females)
- No allergy to fish oil, olive oil, or orange essential oil
- 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)
- 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)
- No alcohol, recreational drug, or smoking/vaping use in the past 1 month
- 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
- Not currently or previously participating in any other clinical trial within the last 30 calendar days
- Signed informed consent, HIPAA Authorization, and Confidentiality Agreement
- Failure to meet any of the above inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fish oil + wild orange essential oil supplement Fish oil + wild orange essential oil supplement Participants in this arm will take three capsules of a fish oil + wild orange essential oil supplement daily for approximately six weeks. Fish oil supplement Fish oil supplement Participants in this arm will take three capsules of a fish oil essential oil supplement daily for approximately six weeks.
- Primary Outcome Measures
Name Time Method Triglycerides (mg/dL) 6 weeks Item in lipid panel for efficacy assessment
Gene expression 6 weeks 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.
Interleukin 6 (pg/mL) 6 weeks Serum marker for inflammation
High sensitivity C-reactive protein (mg/L) 6 weeks Serum marker for inflammation and cardiac health
Omega-3 blood levels (%) 6 weeks Assessment of omega-3 fatty acid concentration in blood
High density lipoprotein (HDL) Cholesterol (mg/dL) 6 weeks Item in lipid panel for efficacy assessment
Very Low density lipoprotein (VLDL) Cholesterol (mg/dL) 6 weeks Item in lipid panel for efficacy assessment
Apolipoprotein B (mg/dL) 6 weeks Serum marker for cardiovascular disease risk
Total cholesterol (mg/dL) 6 weeks Item in lipid panel for efficacy assessment
Low density lipoprotein (LDL) Cholesterol (mg/dL) 6 weeks Item in lipid panel for efficacy assessment
- Secondary Outcome Measures
Name Time Method Red cell distribution width (%) 6 weeks Item in complete blood count for safety assessment
Chloride (mmol/L) 6 weeks Item in comprehensive metabolic panel for safety assessment
Albumin (g/dL) 6 weeks Item in comprehensive metabolic panel for safety assessment
Blood urea nitrogen (BUN) (mg/dL) 6 weeks Item in comprehensive metabolic panel for safety assessment
Calcium (mg/dL) 6 weeks Item in comprehensive metabolic panel for safety assessment
Carbon Dioxide (mmol/L) 6 weeks Item in comprehensive metabolic panel for safety assessment
Sodium (mmol/L) 6 weeks Item in comprehensive metabolic panel for safety assessment
Hematocrit (%) 6 weeks Item in complete blood count for safety assessment
Neutrophils (%) 6 weeks Item in complete blood count for safety assessment
Eosinophils (%) 6 weeks Item in complete blood count for safety assessment
Basophils (%) 6 weeks Item in complete blood count for safety assessment
Neutrophils (Absolute) (x10E3/uL) 6 weeks Item in complete blood count for safety assessment
Monocytes (Absolute) (x10E3/uL) 6 weeks Item in complete blood count for safety assessment
Immature granulocytes (%) 6 weeks Item in complete blood count for safety assessment
Immature granulocytes (Absolute) (x10E3/uL) 6 weeks Item in complete blood count for safety assessment
Safety/tolerability 6 weeks This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses.
Creatinine (mg/dL) 6 weeks Item in comprehensive metabolic panel for safety assessment
Alkaline phosphatase (U/L) 6 weeks Item in comprehensive metabolic panel for safety assessment
Alanine transaminase (ALT) (U/L) 6 weeks Item in comprehensive metabolic panel for safety assessment
Aspartate aminotransferase (AST) (U/L) 6 weeks Item in comprehensive metabolic panel for safety assessment
Body mass index (BMI) 6 weeks Determine whether body mass index is affected by the consumption of the study product.
Hemoglobin (g/dL) 6 weeks Item in complete blood count for safety assessment
Mean corpuscular hemoglobin (pg) 6 weeks Item in complete blood count for safety assessment
Mean corpuscular hemoglobin concentration (g/dL) 6 weeks Item in complete blood count for safety assessment
Platelets (x10E3/uL) 6 weeks Item in complete blood count for safety assessment
Potassium (mmol/L) 6 weeks Item in comprehensive metabolic panel for safety assessment
Lymphocytes (%) 6 weeks Item in complete blood count for safety assessment
Total bilirubin (mg/dL) 6 weeks Item in comprehensive metabolic panel for safety assessment
Total protein (g/dL) 6 weeks Item in comprehensive metabolic panel for safety assessment
Heart rate (BPM) 6 weeks Determine whether heart rate is affected by the consumption of the study product.
White blood cells (x10E3/uL) 6 weeks Item in complete blood count for safety assessment
Red blood cells (x10E6/uL) 6 weeks Item in complete blood count for safety assessment
Lymphocytes (Absolute) (x10E3/uL) 6 weeks Item in complete blood count for safety assessment
Patient Health Questionnaire (PHQ-8) scale 6 weeks Self-reported scale for the measurement of depression severity
Leeds Sleep Evaluation Questionnaire (LSEQ) scale 6 weeks Self-reported scale for the measurement of sleep quality
Blood pressure (mmHg) 6 weeks Determine whether blood pressure is affected by the consumption of the study product.
Mean corpuscular volume (fL) 6 weeks Item in complete blood count for safety assessment
Monocytes (%) 6 weeks Item in complete blood count for safety assessment
Basophils (Absolute) (x10E3/uL) 6 weeks Item in complete blood count for safety assessment
Generalized Anxiety Disorder-7 (GAD-7) scale 6 weeks Self-reported scale for the measurement of anxiety severity
Short Form-20 (SF-20) scale 6 weeks Self-reported scale for assessment of subjective quality of life
Trial Locations
- Locations (1)
doTERRA International
ðºðžPleasant Grove, Utah, United States