Omega-3 Supplement and Health Markers

Evaluation of a Fish Oil-based, Essential-oil Infused Supplement on Markers of Health

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Fish oil + wild orange essential oil supplement; Dietary supplement: Fish oil supplement

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Pleasant Grove, Utah, United States, 84062
      • dōTERRA International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Fish oil + wild orange essential oil supplement; This supplement contains fish oil and wild orange essential oil as its active ingredients.
Active Comparator: Fish oil supplement; Participants in this arm will take three capsules of a fish oil essential oil supplement daily for approximately six weeks.	Dietary supplement: Fish oil supplement; This supplement contains fish oil as its active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: dōTERRA International
• Investigators: Principal Investigator: Nicole Stevens, PhD, dōTERRA International

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Actual): August 28, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Omega-3; Fish oil; Gene expression; Wild orange essential oil
• Other Study ID Numbers: DO-124023-OWO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No