Clinical trial NCT06492694: Omega-3 Supplement and Health Markers
Official title: Evaluation of a Fish Oil-based, Essential-oil Infused Supplement on Markers of Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Fish oil
Omega-3
Gene expression
Wild orange essential oil
Lead sponsor: dōTERRA International
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Exclusion Criteria:

* Failure to meet any of the above inclusion criteria

Primary outcomes:
measure: Gene expression
timeFrame: 6 weeks
measure: Interleukin 6 (pg/mL)
timeFrame: 6 weeks
measure: High sensitivity C-reactive protein (mg/L)
timeFrame: 6 weeks
measure: Apolipoprotein B (mg/dL)
timeFrame: 6 weeks
measure: Total cholesterol (mg/dL)
timeFrame: 6 weeks
measure: Triglycerides (mg/dL)
timeFrame: 6 weeks
measure: High density lipoprotein (HDL) Cholesterol (mg/dL)
timeFrame: 6 weeks
measure: Very Low density lipoprotein (VLDL) Cholesterol (mg/dL)
timeFrame: 6 weeks
measure: Low density lipoprotein (LDL) Cholesterol (mg/dL)
timeFrame: 6 weeks
measure: Omega-3 blood levels (%)
timeFrame: 6 weeks
Secondary outcomes:
measure: Albumin (g/dL)
timeFrame: 6 weeks
measure: Blood urea nitrogen (BUN) (mg/dL)
timeFrame: 6 weeks
measure: Creatinine (mg/dL)
timeFrame: 6 weeks
measure: Alkaline phosphatase (U/L)
timeFrame: 6 weeks
measure: Alanine transaminase (ALT) (U/L)
timeFrame: 6 weeks
measure: Aspartate aminotransferase (AST) (U/L)
timeFrame: 6 weeks
measure: Calcium (mg/dL)
timeFrame: 6 weeks
measure: Carbon Dioxide (mmol/L)
timeFrame: 6 weeks
measure: Chloride (mmol/L)
timeFrame: 6 weeks
measure: Potassium (mmol/L)
timeFrame: 6 weeks
measure: Sodium (mmol/L)
timeFrame: 6 weeks
measure: Total bilirubin (mg/dL)
timeFrame: 6 weeks
measure: Total protein (g/dL)
timeFrame: 6 weeks
measure: Body mass index (BMI)
timeFrame: 6 weeks
measure: Blood pressure (mmHg)
timeFrame: 6 weeks
measure: Heart rate (BPM)
timeFrame: 6 weeks
measure: White blood cells (x10E3/uL)
timeFrame: 6 weeks
measure: Red blood cells (x10E6/uL)
timeFrame: 6 weeks
measure: Hemoglobin (g/dL)
timeFrame: 6 weeks
measure: Hematocrit (%)
timeFrame: 6 weeks
measure: Mean corpuscular volume (fL)
timeFrame: 6 weeks
measure: Mean corpuscular hemoglobin (pg)
timeFrame: 6 weeks
measure: Mean corpuscular hemoglobin concentration (g/dL)
timeFrame: 6 weeks
measure: Red cell distribution width (%)
timeFrame: 6 weeks
measure: Platelets (x10E3/uL)
timeFrame: 6 weeks
measure: Neutrophils (%)
timeFrame: 6 weeks
measure: Lymphocytes (%)
timeFrame: 6 weeks
measure: Monocytes (%)
timeFrame: 6 weeks
measure: Eosinophils (%)
timeFrame: 6 weeks
measure: Basophils (%)
timeFrame: 6 weeks
measure: Neutrophils (Absolute) (x10E3/uL)
timeFrame: 6 weeks
measure: Lymphocytes (Absolute) (x10E3/uL)
timeFrame: 6 weeks
measure: Monocytes (Absolute) (x10E3/uL)
timeFrame: 6 weeks
measure: Basophils (Absolute) (x10E3/uL)
timeFrame: 6 weeks
measure: Immature granulocytes (%)
timeFrame: 6 weeks
measure: Immature granulocytes (Absolute) (x10E3/uL)
timeFrame: 6 weeks
measure: Safety/tolerability
timeFrame: 6 weeks
measure: Generalized Anxiety Disorder-7 (GAD-7) scale
timeFrame: 6 weeks
measure: Patient Health Questionnaire (PHQ-8) scale
timeFrame: 6 weeks
measure: Leeds Sleep Evaluation Questionnaire (LSEQ) scale
timeFrame: 6 weeks
measure: Short Form-20 (SF-20) scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Pleasant Grove
country: United States
facility: doTERRA International
state: Utah
Study officials:
affiliation: doTERRA International
name: Nicole Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: