Evaluation of a Fish Oil-based, Essential-oil Infused Supplement on Markers of Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- Triglycerides (mg/dL)
Study Overview
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:
- How does daily ingestion of fish oil supplements affect gene expression, omega-3 levels, and protein markers as measured in blood?
- How does daily ingestion of fish oil supplements affect anthropometric measurements?
- How does daily ingestion of fish oil supplements affect subjective quality of life and health parameters?
- Do fish oil + wild orange essential oil supplements produce different outcomes than fish oil supplements alone?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Failure to meet any of the above inclusion criteria
Outcomes
Primary Outcomes
Triglycerides (mg/dL)
Time Frame: 6 weeks
Item in lipid panel for efficacy assessment
Gene expression
Time Frame: 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)
Time Frame: 6 weeks
Serum marker for inflammation
High sensitivity C-reactive protein (mg/L)
Time Frame: 6 weeks
Serum marker for inflammation and cardiac health
Omega-3 blood levels (%)
Time Frame: 6 weeks
Assessment of omega-3 fatty acid concentration in blood
High density lipoprotein (HDL) Cholesterol (mg/dL)
Time Frame: 6 weeks
Item in lipid panel for efficacy assessment
Very Low density lipoprotein (VLDL) Cholesterol (mg/dL)
Time Frame: 6 weeks
Item in lipid panel for efficacy assessment
Apolipoprotein B (mg/dL)
Time Frame: 6 weeks
Serum marker for cardiovascular disease risk
Total cholesterol (mg/dL)
Time Frame: 6 weeks
Item in lipid panel for efficacy assessment
Low density lipoprotein (LDL) Cholesterol (mg/dL)
Time Frame: 6 weeks
Item in lipid panel for efficacy assessment
Secondary Outcomes
- Albumin (g/dL)(6 weeks)
- Blood urea nitrogen (BUN) (mg/dL)(6 weeks)
- Calcium (mg/dL)(6 weeks)
- Carbon Dioxide (mmol/L)(6 weeks)
- Sodium (mmol/L)(6 weeks)
- Hematocrit (%)(6 weeks)
- Neutrophils (%)(6 weeks)
- Eosinophils (%)(6 weeks)
- Basophils (%)(6 weeks)
- Neutrophils (Absolute) (x10E3/uL)(6 weeks)
- Monocytes (Absolute) (x10E3/uL)(6 weeks)
- Immature granulocytes (%)(6 weeks)
- Immature granulocytes (Absolute) (x10E3/uL)(6 weeks)
- Safety/tolerability(6 weeks)
- Creatinine (mg/dL)(6 weeks)
- Alkaline phosphatase (U/L)(6 weeks)
- Alanine transaminase (ALT) (U/L)(6 weeks)
- Aspartate aminotransferase (AST) (U/L)(6 weeks)
- Body mass index (BMI)(6 weeks)
- Hemoglobin (g/dL)(6 weeks)
- Mean corpuscular hemoglobin (pg)(6 weeks)
- Mean corpuscular hemoglobin concentration (g/dL)(6 weeks)
- Platelets (x10E3/uL)(6 weeks)
- Potassium (mmol/L)(6 weeks)
- Lymphocytes (%)(6 weeks)
- Chloride (mmol/L)(6 weeks)
- Total bilirubin (mg/dL)(6 weeks)
- Total protein (g/dL)(6 weeks)
- Heart rate (BPM)(6 weeks)
- White blood cells (x10E3/uL)(6 weeks)
- Red blood cells (x10E6/uL)(6 weeks)
- Lymphocytes (Absolute) (x10E3/uL)(6 weeks)
- Patient Health Questionnaire (PHQ-8) scale(6 weeks)
- Leeds Sleep Evaluation Questionnaire (LSEQ) scale(6 weeks)
- Blood pressure (mmHg)(6 weeks)
- Mean corpuscular volume (fL)(6 weeks)
- Red cell distribution width (%)(6 weeks)
- Monocytes (%)(6 weeks)
- Basophils (Absolute) (x10E3/uL)(6 weeks)
- Generalized Anxiety Disorder-7 (GAD-7) scale(6 weeks)
- Short Form-20 (SF-20) scale(6 weeks)