Absorption and Digestion Kinetics of Human Metabolites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Circulating Plasma Levels of Metabolites
研究概览
简要总结
The purpose of this pilot study is to evaluate the effects oral supplementation with four human metabolites (spermidine, nicotinamide, palmitoylethanolamide (PEA), and oleoylethanolamide(OEA)) at varying doses on the circulating blood levels of these metabolites as well as their immediate effects on plasma functionality and postprandial inflammation. 5 young healthy subjects will participate in a four armed study consisting of a Placebo arm and a Low, Medium, and High Dose arm. Subjects will be given a standardized breakfast along with supplementation with either an escalating dose (Low: 1x, Medium: 2x, High: 3x) of a combination of spermidine, nicotinamide, PEA and OEA or a placebo control and a time course of their blood plasma will be collected after supplementation. Plasma samples will be assessed for their concentration of spermidine, nicotinamide, PEA, and OEA as well as their experimental and clinical functionalities including their anti-inflammatory, antioxidant, and cholesterol efflux abilities on primary human macrophage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: 20-40 years old to constitute a young study population
- •BMI: 19-27 kg/m2 to constitute a normal/healthy weight population
- •Weight: 133lbs or more
- •Subjects must be willing and able to consume a standardized breakfast bar containing cashews and dates (Larabar).
- •Subjects must be willing to consume oral dietary supplement versions of spermidine, 1-methlynicotinamide, palmitoylethanolamide, and oleoylethanolamide.
- •Subjects must be willing and able to undergo blood draws at the UC Davis Ragle Nutrition Center at 0, 1, 2, and 4 hours after supplementation with spermidine, niacinamide, palmitoylethanolamide, and oleoylethanolamide.
排除标准
- •Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer, autoimmune diseases, or previous cardiovascular events
- •Any inflammatory bowel disease including IBS, Crohn's Disease, Celiac Disease
- •Any allergy or sensitivity to wheat, gluten, or soy products
- •Consumption of >1 alcoholic drink/day
- •Current consumption of any probiotic, prebiotic, or dietary supplements
- •Extreme dietary or exercise patterns
- •Recent weight fluctuations (greater than 10% in the last six months)
- •Regular use of over-the-counter allergy or pain medications (>1/week)
- •Taking prescription lipid medications (e.g. statins) or other supplements known to alter lipoprotein metabolism such as isoflavones.
- •Use of any form of hormonal birth control including oral contraception pills, hormonal IUDs or rings, or hormonal birth control patches
- •Illness such as flu or cold of any kind within the last two weeks
- •Allergy to components of standardized breakfast bar (cashew/dates)
- •Changes to any of the above during the study period.
结局指标
主要结局
Circulating Plasma Levels of Metabolites
时间窗: 1, 2, and 4 hours after ingestion
Quantitative plasma concentrations of spermidine, nicotinamide, pamitoylethanolamide, and oleoylethanolamide (in nmol/L).
次要结局
- Anti-inflammatory capacity of plasma(1, 2, and 4 hours after ingestion)
研究者
Angela Zivkovic, PhD
Associate Professor
University of California, Davis