Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Tolerance
研究概览
简要总结
Tolerance and palatability of short-term supplementation with a whole-food dietary formulation based on hemp oil, calamari oil, and broccoli was evaluated in healthy adults. This was a 10-day open-label, prospective, controlled trial (n=14) in which participants acted as their own controls to receive daily intervention standardized to contain 15 mg phytocannabinoids, 230 mg omega-3 fatty acids, and 5 mg glucoraphanin. The primary objective was to evaluate gastrointestinal tolerability and acceptability. The study demonstrated that daily ingestion of the investigational product was well tolerated with no or minor adverse events, and a good palatability. The secondary objectives were to access parameters of blood biochemistry, liver enzymes, biomarkers of immune and oxi-dative health, as well as phytocannabinoid profiles in urine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is between 18 and 75 years old
- •Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit, and is not actively planning a pregnancy
- •If on a chronic medication (that does not result in exclusion), subject has been on stable dose for at least two months prior to screening visit
- •Subject has at least two week wash out period between completion of a previous research study that required ingestion of any study food or drug, and their start in the current study
- •No allergy to any study products
- •Willingness to comply with study protocol for 10 days
排除标准
- •Subjects who are experiencing any adverse events due to any nutraceutical, OTC, pharmaceutical, or investigational products
- •Subjects may not receive any other investigational products not part of normal clinical care
- •Lipid lowering drugs or the use of anticoagulant medications in the preceding 4 weeks and for duration of trial
- •Subjects with untreated endocrine, neurological, or infectious disease
- •Subjects with a current diagnosis or personal history of: significant liver or kidney disease, autoimmune disorders, deep vein thrombosis, history of cancer
- •Serious medical illness including a history of attempted suicide
- •Use of ethanol within 24 hours of the evaluation visits (baseline, and end of the study visit
- •Do not comply with the study protocol
结局指标
主要结局
Tolerance
时间窗: 10 days
gastrointestinal and general health measured by daily questionnaire, this is a numbered scale from 1-9 from the Global Quality of Life scale
palatability
时间窗: 10 days
palatability of Standard Process Hemp Oil Complex by questionnaire scale.
次要结局
- Oxidative Stress Biomarkers(1 month)
- Medical Symptom Questionnaire (MSQ)(10 days)
- Liver Enzymes(1 month)