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临床试验/NCT04583722
NCT04583722已完成不适用

Clinical Evaluation of a New Encapsulation Technology for Improving Astaxanthin Bioavailability Based on Natural Food Ingredients Only

Yoav D. Livney1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
1
主要终点
Plasma AX AUC

研究概览

简要总结

The purpose of this study was to develop a potato protein (PP)-based delivery system for increasing oral bioavailability of lipophilic bioactives (nutraceuticals and drugs), using astxanthin (AX) as a model, and to evaluate the system in vivo in a crossover clinical study in human volunteers. Three different formulations were prepared, encapsulating AX oleoresin (AXO) with (1) PP only, (2) PP+lecithin (LEC), and (3) PP+olive oil (OO). In a randomized, double-blind, crossover study in human subjects, the PP-OO-AX formulation had a 4.8-fold higher median plasma AX area under the concentration-over time curve (AUC; P<0.001) compared to the raw AXO formulation.

In conclusion, a non-allergenic, vegan, PP based delivery system made of "all-natural ingredients" offers a great promise for increasing oral bioavailability of lipophilic bioactives such as AX, for the enrichment of food and for dietary supplements, or oral delivery of lipophilic drugs.

详细描述

Astaxanthin (AX) is a red xanthophyll carotenoid found mainly in algae (notably Haematococcus Pluvialis microalga) and marine animals. AX is a stronger antioxidant than vitamin E and β-carotene but has very low oral bioavailability. The purpose of this study was to develop a potato protein (PP)-based delivery system for increasing oral bioavailability of lipophilic bioactives (nutraceuticals and drugs), using AX as a model, and to evaluate the system in vitro and in vivo in a crossover clinical study in human volunteers. Three different formulations were prepared, encapsulating AX oleoresin (AXO) with (1) PP only, (2) PP+lecithin (LEC), and (3) PP+olive oil (OO). The average particle diameters after preparation were 0.29, 0.29, and 1.76 μm, and after freeze-drying and reconstitution 0.17, 0.07, and 6.93 μm, respectively. In vitro bioaccessibility was 33, 47, and 69%, respectively, versus 16% only for the raw AXO. In a randomized, double-blind, crossover study in human subjects, the PP-OO-AX formulation had a 4.8-fold higher median plasma AX area under the concentration-over time curve (AUC; P<0.001) compared to the raw AXO formulation. In conclusion, a non-allergenic, vegan, PP based delivery system made of "all-natural ingredients" offers a great promise for increasing oral bioavailability of lipophilic bioactives such as AX, for the enrichment of food and for dietary supplements, or oral delivery of lipophilic drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers
  • Aged 18 - 26
  • Normal physical examination
  • Normal electrocardiogram (E.C.G.)
  • Normal laboratory profile

排除标准

  • Any active medical illness (e.g. liver disease, kidney disease, or diabetes, intestinal malabsorption, hypercalcemia)
  • Lactose intolerance
  • Food allergies
  • Excessive alcohol use (over 40 ml/day)
  • Pregnant or breast-feeding
  • Hyperlipidemia (LDL>130, triglycerides>200)
  • Regular medication use
  • Obesity (BMI>30 kg/m2)
  • Use of multivitamins, or carotenoid supplements during the past month prior to the study
  • Current smoking

结局指标

主要结局

Plasma AX AUC

时间窗: 1 year

Plasma AX AUC of 13 participants after consuming either the microencapsulated AX or the reference AX oleoresin, measured during 72 hrs post-ingestion, in a cross over study.

次要结局

未报告次要终点

研究者

发起方
Yoav D. Livney
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yoav D. Livney

Prof.

Technion, Israel Institute of Technology

研究点 (1)

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