Evaluation of Frankincense Essential Oil Supplements on Markers of Inflammation and Cellular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- High sensitivity C-reactive protein (mg/L)
研究概览
简要总结
The goal of this clinical trial is to learn whether frankincense essential oil-based supplements can affect gene expression and serum protein markers in healthy volunteers. The main questions it aims to answer are:
- Do frankincense essential oil supplements affect gene expression and protein markers as measured in blood?
- How does daily ingestion of frankincense supplements affect anthropometric measurements, including body mass index, waist circumference, blood pressure, and heart rate?
- How does daily ingestion of frankincense essential oil supplements affect subjective quality of life and health parameters?
- Is ingesting frankincense essential oil supplements daily safe, as measured by laboratory tests and adverse events?
Researchers will compare two types of frankincense essential oil supplements. One type contains frankincense essential oil and boswellic acid as its active ingredients. The other type contains only frankincense essential oil as its active ingredient.
Participants will:
- Be assigned one of the two types of frankincense essential oil supplement
- Take two capsules of their assigned supplement every day for about 30 days
- 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
详细描述
This randomized, double-blind study will recruit healthy men and women to compare gene expression profile and serum protein markers before and after consumption of frankincense essential oil supplements for approximately 4 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 18-64 years old
- •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 7 weeks)
- •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 4 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 5 weeks)
- •Willing to wash out of internally-consumed essential oil and botanical products for approximately 7 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 doctor (Medical Reviewer's discretion)
- •No pregnancy within the last 60 days or currently breastfeeding (females)
- •No allergy to olive oil, frankincense essential oil, or boswellic acid
- •No internal consumption of frankincense oil regularly 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
排除标准
- •Failure to meet any of the above inclusion criteria
结局指标
主要结局
High sensitivity C-reactive protein (mg/L)
时间窗: 4 weeks
Serum marker for inflammation and cardiac health
Gene expression
时间窗: 4 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.
Matrix metalloproteinase-9 (ELISA)
时间窗: 4 weeks
Serum protein involved in inflammatory response and tissue remodeling
Interleukin 6 (pg/mL)
时间窗: 4 weeks
Serum marker for inflammation
Fasting insulin (uIU/mL)
时间窗: 4 weeks
Serum marker used to determine whether insulin levels are affected by the consumption of the study product.
次要结局
- Alkaline phosphatase (U/L)(4 weeks)
- Alanine transaminase (ALT) (U/L)(4 weeks)
- Chloride (mmol/L)(4 weeks)
- Blood pressure (mmHg)(4 weeks)
- Heart rate (BPM)(4 weeks)
- White blood cells (x10E3/uL)(4 weeks)
- Red blood cells (x10E6/uL)(4 weeks)
- Neutrophils (%)(4 weeks)
- Lymphocytes (Absolute) (x10E3/uL)(4 weeks)
- Immature granulocytes (Absolute) (x10E3/uL)(4 weeks)
- Safety/tolerability(4 weeks)
- Generalized Anxiety Disorder-7 (GAD-7) scale(4 weeks)
- Albumin (g/dL)(4 weeks)
- Aspartate aminotransferase (AST) (U/L)(4 weeks)
- Calcium (mg/dL)(4 weeks)
- Total bilirubin (mg/dL)(4 weeks)
- Waist circumference (cm)(4 weeks)
- Creatinine (mg/dL(4 weeks)
- Carbon Dioxide (mmol/L)(4 weeks)
- Total protein (g/dL)(4 weeks)
- Body mass index (BMI)(4 weeks)
- Hemoglobin (g/dL)(4 weeks)
- Hematocrit (%)(4 weeks)
- Basophils (Absolute) (x10E3/uL)(4 weeks)
- Potassium (mmol/L)(4 weeks)
- Sodium (mmol/L)(4 weeks)
- Red cell distribution width (%)(4 weeks)
- Platelets (x10E3/uL)(4 weeks)
- Basophils (%)(4 weeks)
- Short Form-20 (SF-20) scale(4 weeks)
- Blood urea nitrogen (BUN) (mg/dL)(4 weeks)
- Monocytes (%)(4 weeks)
- Eosinophils (%)(4 weeks)
- Neutrophils (Absolute) (x10E3/uL)(4 weeks)
- Lymphocytes (%)(4 weeks)
- Mean corpuscular volume (fL)(4 weeks)
- Mean corpuscular hemoglobin (pg)(4 weeks)
- Mean corpuscular hemoglobin concentration (g/dL)(4 weeks)
- Monocytes (Absolute) (x10E3/uL)(4 weeks)
- Eosinophils (Absolute) (x10E3/uL)(4 weeks)
- Immature granulocytes (%)(4 weeks)
- Patient Health Questionnaire (PHQ-8) scale(4 weeks)
- Leeds Sleep Evaluation Questionnaire (LSEQ) scale(4 weeks)