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
- 1
- 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
研究组 & 干预措施
Supplementation
Participants were enrolled at baseline where all outcome measures were collected. Once baseline visit was complete, participants started with the supplementation of Hemp Oil Complex by Standard Process. After 10 days, outcome measures were collected.
干预措施: Standard Process Hemp Oil Complex (Dietary Supplement)
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
- Medical Symptom Questionnaire (MSQ)(10 days)
- Oxidative Stress Biomarkers(1 month)
- Liver Enzymes(1 month)