Omega-3 Supplement and Health Markers

NCT06492694 | Completed

• 1 other identifier: DO-124023-OWO
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Healthy

Keywords

Fish oil; Omega-3; Gene expression; Wild orange essential oil

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (41)

• Albumin (g/dL)

  6 weeks

• Blood urea nitrogen (BUN) (mg/dL)

  6 weeks

• Creatinine (mg/dL)

  6 weeks

• Alkaline phosphatase (U/L)

  6 weeks

• Alanine transaminase (ALT) (U/L)

  6 weeks

Study Arms (2)

Fish oil + wild orange essential oil supplement

EXPERIMENTAL

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

Fish oil supplement

ACTIVE COMPARATOR

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

Interventions

Fish oil + wild orange essential oil supplement DIETARY_SUPPLEMENT

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

Fish oil + wild orange essential oil supplement

Fish oil supplement DIETARY_SUPPLEMENT

This supplement contains fish oil as its active ingredient.

Fish oil supplement

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• dōTERRA International: lead

Study Sites (1)

doTERRA International

Pleasant Grove, Utah, 84062, United States

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Nicole Stevens, PhD

  doTERRA International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: June 10, 2024
• Primary Completion: August 28, 2024
• Study Completion: September 3, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

US (1)