NCT03017651已完成1 期
An Evaluation of a Proprietary Omega-3 Fatty Acid Incorporated Into a MAG on Blood EPA and DHA Levels: a PK Study
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- AUC0-t
研究概览
简要总结
This protocol will determine the pK profile of two different omega-3 fatty acid supplements on plasma EPA and DHA levels.
详细描述
This protocol is to assess the omega-3 blood levels of DHA and EPA following a single dose administration of study products by means of pharmacokinetics over a 24 hour period of time (post-dose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between 18 and 65 years old (inclusive)
- •Body Mass Index (BMI) between 25.0 and 34.9 kg/m2 (inclusive) at Screening.
- •Subjects with normal or moderately elevated lipidemia (borderline lipids as defined by the AACE - Total cholesterol ≤ 240 mg/dl; LDL ≤ 160 mg/dl; TG ≤ 199 mg/dl).
- •Subjects with no clinically significant findings in the physical examination, medical history, vital signs, clinical laboratory test (hematology and serum chemistry) results and as deemed by the Investigator.
- •Subjects must understand and agree to comply with the requirements of the study and they must be willing to sign the informed consent indicating voluntary consent to participate in the study prior to the initiation of Screening or study related activities.
- •Male and female subjects of childbearing potential must agree to use one of the following medically acceptable contraceptive methods for the duration of the study: same-sex partner; double barrier (condom, diaphragm or cervical cap with spermicidal foam, gel or cream); IUD (with or without hormones) in place or hormonal contraception (oral, injectable, implantable, transdermal or vaginal) used consecutively for at least 3 months prior to study product administration; vasectomized partner or sterilization by bilateral insertion of Essure® or similar product for 6 months minimum prior to study product administration; bilateral tubal ligation, hysterectomy and/or bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to study product administration
排除标准
- •Currently using fish oil capsules (supplements or prescription products).
- •Regular use of omega-3 supplements (defined as greater than 500 mg/week) within 4 weeks of study product administration.
- •Currently using any medications that may impact dietary fat absorption (i.e., Orlistat, Alli, etc.).
- •Currently using any medications that may interfere with omega-3 uptake (i.e. blood thinning medication or anticoagulants).
- •Currently using any lipid lowering medications (i.e. any cholesterol or triglyceride lowering agent).
- •Currently consuming high amounts of EPA & DHA in the diet (as defined by greater than 200 mg/day by FFQ)
- •Currently following a self-reported no-fat or ultra-restrictive (less than 15%) Low-Fat Diet
- •Having the following medical conditions:
- •i. Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc.
- •ii. Hypertriglyceridemia (as defined by the Inclusion and per PI discretion; Total cholesterol > 240 mg/dl; LDL > 160 mg/dl; TG > 199 mg/dl) iii. Type2 Diabetes Mellitus
- •Currently a smoker or nicotine user or has been nicotine free for less than 6 months
- •Use of any systemic medications, including OTC medications, herbal products, dietary supplements or vitamins (not previously listed) within 1 week of study product administration (occasional use of OTC analgesics such as acetaminophen may be allowed as judged by the Investigator)
- •Evidence or history of allergic or adverse responses to either study product, any of the product excipients or any comparable or similar products
- •Subjects who are not willing and not able to comply with scheduled visits and the requirements of the study protocol.
- •Female subjects who are breastfeeding, pregnant or plan to become pregnant during this study.
- •Current employee or immediate family member of the study sponsor or study site personnel.
- •Currently participating or have participated in another clinical trial within 4 weeks of study product administration
- •Donated blood, blood components, or significant loss of blood within 30 days of study product administration
- •History of a clinically-significant illness within 4 weeks of study product administration
- •History of hospitalization or treatment for clinically-significant drug or alcohol use/abuse within 1 year of dosing.
- •Subject has poor venous access or difficulty swallowing capsules
- •Any other issue which, in the judgment of the Investigator, will make the subject ineligible for study participation
结局指标
主要结局
AUC0-t
时间窗: from 0 to 24 hours
The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
次要结局
- tmax(between 0 and 24 hours)
- t½(between 0 and 24 hours)
- Cmax(between 0 and 24 hours)
- AUC0-inf(from 0 to infinity)
研究者
研究点 (2)
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