Omega-3 Supplement and Health Markers

NCT ID: NCT06492694

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2024-09-03

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fish oil + wild orange essential oil supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Fish oil supplement

Participants in this arm will take three capsules of a fish oil essential oil supplement daily for approximately six weeks.

Group Type: ACTIVE_COMPARATOR

Fish oil supplement

Intervention Type: DIETARY_SUPPLEMENT

This supplement contains fish oil as its active ingredient.

Interventions

Fish oil + wild orange essential oil supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Fish oil supplement

This supplement contains fish oil as its active ingredient.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

dōTERRA International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

doTERRA International

Locations

doTERRA International

Pleasant Grove, Utah, United States

Countries

United States

Other Identifiers

DO-124023-OWO

Identifier Type: -

Identifier Source: org_study_id