doTERRA International
Pleasant Grove, Utah, 84062, United States
NCT Number: NCT06492694
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
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Notify Me18 year–64 year
All sexes
Interventional
Not applicable
Pleasant Grove, Utah, 84062, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This supplement contains fish oil and wild orange essential oil as its active ingredients.
This supplement contains fish oil as its active ingredient.
Time frame: 6 weeks
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
Serum marker for inflammation
Time frame: 6 weeks
Serum marker for inflammation and cardiac health
Time frame: 6 weeks
Serum marker for cardiovascular disease risk
Time frame: 6 weeks
Item in lipid panel for efficacy assessment
Time frame: 6 weeks
Item in lipid panel for efficacy assessment
Time frame: 6 weeks
Item in lipid panel for efficacy assessment
Time frame: 6 weeks
Item in lipid panel for efficacy assessment
Time frame: 6 weeks
Item in lipid panel for efficacy assessment
Time frame: 6 weeks
Assessment of omega-3 fatty acid concentration in blood
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Determine whether body mass index is affected by the consumption of the study product.
Time frame: 6 weeks
Determine whether blood pressure is affected by the consumption of the study product.
Time frame: 6 weeks
Determine whether heart rate is affected by the consumption of the study product.
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
Item in complete blood count for safety assessment
Time frame: 6 weeks
This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses.
Time frame: 6 weeks
Self-reported scale for the measurement of anxiety severity
Time frame: 6 weeks
Self-reported scale for the measurement of depression severity
Time frame: 6 weeks
Self-reported scale for the measurement of sleep quality
Time frame: 6 weeks
Self-reported scale for assessment of subjective quality of life
dōTERRA International
Industry
Evaluation of a Fish Oil-based, Essential-oil Infused Supplement on Markers of Health
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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