Metabolic and Epigenetic Impact of Concomitant Fatty Acid Amide Hydrolase Inhibitors and Oleoylethanolamide in a Novel Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Gene expression
研究概览
简要总结
The goal of this clinical trial is to learn whether a dietary supplement can affect gene expression and serum protein markers in healthy volunteers. The main questions it aims to answer are:
- Does the supplement affect gene expression and protein markers as measured in blood?
- How does daily ingestion of the supplement affect anthropometric measurements, including body mass index, waist circumference, blood pressure, and heart rate?
- How does daily ingestion of the supplement affect subjective health parameters?
- Is ingesting the supplement daily safe, as measured by laboratory tests and adverse events?
The supplement is made with oleoylethanolamide (OEA), ginger extract, and lavender essential oil.
Participants will:
- Take one supplement capsule in the morning and one in the evening every day for 12 weeks
- Attend three study visits in which they provide blood and urine samples, and undergo anthropometric measurements
- Complete surveys and subjective health assessments
详细描述
This open-label, repeated measures study will recruit healthy men and women to compare gene expression profile and serum protein markers before and after consumption of a dietary supplement for 12 weeks. Secondary outcomes include anthropometric measurements, vitals, and other subjective health assessments. Safety data (from blood sampling, urinalysis, and adverse events) will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adults ages 18-64 years old
- •BMI 25-30 inclusive (self-reported for screening, confirmed at first study visit)
- •For purposes of blood collection and other in-person procedures:
- •o Reside within driving distance of the study center or be willing to travel to the study center
- •Willing and able to undergo three blood draws over 12 weeks
- •Willing to wash out of all internally-consumed essential oils or botanical products for at least 2 weeks prior to starting the study, and willing to maintain the washout for the duration of the study (14 weeks).
- •Willing and able to consume study product twice daily for about 12 weeks
- •Willing to track consumption of study product
- •Willing to keep diet, exercise, sleep habits, and current non-study supplement use the same throughout the study
- •Willing to limit alcohol consumption to "social drinking" (typically no more than 3 drinks per day and 7 per week) during the study
- •History of alcohol consumption limited to "social drinking" (typically no more than 3 drinks per day and 7 per week)
- •Willing to avoid recreational drugs and smoking/vaping for the duration of the study (approximately 12 weeks)
- •No metabolic disease (BMI>30, 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, lavender essential oil, ginger oleoresin/extract/essential oil, or OEA.
- •No regular internal consumption of lavender essential oil, ginger oleoresin or extract, or OEA 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 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
- •No recreational drug or smoking/vaping use in the past 1 month
- •Not currently or previously participating in any other clinical trial within the last 30 calendar days
排除标准
- •Failure to meet all inclusion criteria
研究组 & 干预措施
Dietary supplement
Participants take two capsules of the dietary supplement (one capsule in the morning and one in the evening) every day for 12 weeks.
干预措施: OEA supplement (Dietary Supplement)
结局指标
主要结局
Gene expression
时间窗: 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. The changes will be evaluated before and after treatment with the study supplement for 6 weeks.
Hemoglobin A1C (HbA1c) (%)
时间窗: 12 weeks
Change in blood HbA1c value before and after 12 weeks of treatment with the study supplement.
次要结局
- Complete blood count (CBC)(12 weeks)
- Generalized Anxiety Disorder-7 (GAD-7) scale(12 weeks)
- Leptin (ng/mL)(12 weeks)
- Comprehensive metabolic panel (CMP)(12 weeks)
- Apolipoprotein B (ApoB) (mg/dL)(12 weeks)
- Leeds Sleep Evaluation Questionnaire (LSEQ) scale(12 weeks)
- Blood pressure (mmHg)(12 weeks)
- Heart rate (BPM)(12 weeks)
- Safety/tolerability(12 weeks)
- High sensitivity C-reactive protein (mg/dL)(12 weeks)
- Patient Health Questionnaire (PHQ-8) scale(12 weeks)
- Body weight (kg)(12 weeks)
- Lipid panel(12 weeks)
- Waist circumference (cm)(12 weeks)
- Erythrocyte Sedimentation Rate (ESR) (mm/h)(12 weeks)
研究者
Nicole Stevens, PhD
Vice President, Clinical Research
dōTERRA International