Omega-3 Supplement and Health Markers

dōTERRA International55 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Interventions

Fish oil + wild orange essential oil supplementDIETARY_SUPPLEMENT

This supplement contains fish oil and wild orange essential oil as its active ingredients.

Fish oil supplementDIETARY_SUPPLEMENT

This supplement contains fish oil as its active ingredient.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

doTERRA International

Pleasant Grove, Utah, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks

Interleukin 6 (pg/mL)

Serum marker for inflammation

Time frame: 6 weeks

High sensitivity C-reactive protein (mg/L)

Serum marker for inflammation and cardiac health

Time frame: 6 weeks

Apolipoprotein B (mg/dL)

Serum marker for cardiovascular disease risk

Time frame: 6 weeks

Total cholesterol (mg/dL)

Item in lipid panel for efficacy assessment

Time frame: 6 weeks

Triglycerides (mg/dL)

Item in lipid panel for efficacy assessment

Time frame: 6 weeks

High density lipoprotein (HDL) Cholesterol (mg/dL)

Item in lipid panel for efficacy assessment

Time frame: 6 weeks

Very Low density lipoprotein (VLDL) Cholesterol (mg/dL)

Item in lipid panel for efficacy assessment

Time frame: 6 weeks

Low density lipoprotein (LDL) Cholesterol (mg/dL)

Item in lipid panel for efficacy assessment

Time frame: 6 weeks

Omega-3 blood levels (%)

Assessment of omega-3 fatty acid concentration in blood

Time frame: 6 weeks

Secondary Outcomes

Albumin (g/dL)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Blood urea nitrogen (BUN) (mg/dL)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Creatinine (mg/dL)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Alkaline phosphatase (U/L)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Alanine transaminase (ALT) (U/L)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Aspartate aminotransferase (AST) (U/L)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Calcium (mg/dL)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Carbon Dioxide (mmol/L)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Chloride (mmol/L)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Potassium (mmol/L)

Item in comprehensive metabolic panel for safety assessment

Data from ClinicalTrials.gov

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Sodium (mmol/L)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Total bilirubin (mg/dL)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Total protein (g/dL)

Item in comprehensive metabolic panel for safety assessment

Time frame: 6 weeks

Body mass index (BMI)

Determine whether body mass index is affected by the consumption of the study product.

Time frame: 6 weeks

Blood pressure (mmHg)

Determine whether blood pressure is affected by the consumption of the study product.

Time frame: 6 weeks

Heart rate (BPM)

Determine whether heart rate is affected by the consumption of the study product.

Time frame: 6 weeks

White blood cells (x10E3/uL)