NCT02712593已完成2 期
A Randomized, Double-blind, Placebo Controlled Parallel Study Investigating the Effects of Niagen™ (Nicotinamide Riboside) on Niagen™ Metabolites in Healthy Adults.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Urinary Methylnicotinamide
研究概览
简要总结
This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a placebo. One quarter of subjects will receive the low dose of Niagen™, one quarter will receive the moderate dose of Niagen™, one quarter will receive the higher dose of Niagen™ and one quarter will reveive the placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 25-30kg/m²
- •If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Double-barrier method
- •Non-hormonal intrauterine devices
- •Vasectomy of partner
- •Healthy as determined by laboratory results, medical history, and physical exam
- •Agrees to comply with study procedure
- •Agrees to maintain current level of physical activity throughout the study and avoid exercising on the day of study visits 3 to 7 (prior to the visit).
- •Agrees to refrain from consuming caffeine (i.e. coffee) on the days of study visits 3 to 7 (prior to the visit)
- •Agrees to avoid taking Vitamin B3 (niacin, nicotinic acid,niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period
- •Has given voluntary, written, informed consent to participate in the study
- •Agrees to avoid foods that contain high amounts of tryptophan and niacin and limit their ingestion of foods containing moderate amounts of tryptophan and niacin
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- •Alcohol use >2 standard alcoholic drinks per day
- •History of alcohol or drug abuse within the past year
- •Medicinal use of marijuana
- •Diabetes (Type I or Type II)
- •Subjects taking lipid lowering drugs
- •History of renal and/or liver disease
- •History of pellagra or niacin deficiency
- •Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, and neurological disorders including epilepsy, and recent cerebrovascular disease
- •Subjects with or who had recently experienced a traumatic injury, inflammation, infections or had undergone surgery
- •Use of natural health products containing NR within 14 days prior to randomization and during the course of the study
- •Unstable medical conditions as determined by the Qualified Investigator
- •Clinically significant abnormal lab results at screening (e.g. AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN) will be assessed by the Medical Investigator
- •History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable
- •Participation in a clinical research trial within 30 days prior to randomization
- •Allergy or sensitivity to study supplement ingredients
- •Allergy or sensitivity to lidocaine
- •Bleeding disorder
- •Serum creatinine ≥ 130µmol/L for males and ≥ 125µmol/L for female
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or which may pose significant risk to the subjects
研究组 & 干预措施
Niagen™ 100
Experimental
干预措施: Niagen™ 100 (Dietary Supplement)
Niagen™ 300
Experimental
干预措施: Niagen™ 300 (Dietary Supplement)
Niagen™ 1000
Experimental
干预措施: Niagen™ 1000 (Dietary Supplement)
Placebo
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Urinary Methylnicotinamide
时间窗: 8 weeks: from baseline to end of study
Change in levels
次要结局
- Blood Nicotinamide Riboside Metabolites(8 weeks: from baseline to end of study)
- Urinary Nicotinamide Riboside Metabolites(8 weeks: from baseline to end of study)
- Muscle Nicotinamide Riboside Metabolites(8 weeks: from baseline to end of study)
研究者
研究点 (2)
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