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临床试验/NCT02450227
NCT02450227终止不适用

Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices - a Explorative Study in Short-bowel Patients and Healthy Controls - The "Popeye-study"

University of Copenhagen4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
4
主要终点
Serum concentration of lutein and beta-carotene

研究概览

简要总结

Absorption and metabolism of carotenoids from two types of spinach preparations will be investigated in two study groups, short bowel/ileostomy and healthy, respectively.

The study will be conducted as a randomised, controlled, 2-way crossover study in 24 participants (12 in each group), randomized to two sequences (1-2, 2-1) of interventions with a more and a less bio-accessible spinach preparation. The serum, chylomicron and fecal/effluent levels of lutein and beta-carotene will be determined.

详细描述

Absorption and metabolism of carotenoids from two types of spinach preparations will be investigated in two study groups, short bowel/ileostomy and healthy, respectively.

The study will be conducted as a randomised, controlled, 2-way crossover study. Twenty four participants (12 in each group) will be randomized to two sequences (1-2, 2-1) of interventions with a more and a less bio-accessible spinach preparation (differentiates only on the basis of particle size).

The intervention period is sub-divided into three parts: run-in period (48 hours) with a standardized low-carotenoid diet, 0-24 hours (follow-up period 1 (FP1)) and 24 hours - 2 weeks (FP2). The intervention periods will be separated by a wash-out period of at least 14 days.

At start of each intervention, the intervention meal (breakfast) is served, followed by standardized, carotenoid-free meals in the following 24 hours. Participants will in FP1 and FP2 receive an intervention meal every second day. Participants will otherwise keep their habitual diets during these follow-up periods.

Study participants are asked to collect urine during 24 hours before and after the first intervention meal in each period. They will also collect feces/ileostomy efflux for 24 hours before and after initiation of the intervention for short bowel/ileostomy patients and for 48 periods in the healthy volunteers, respectively. Overnight-fasting serum samples are drawn at day 1, 7 and 15 of each intervention period. On day 1 plasma samples are drawn at 0,1, 3, 4, 6, 7, 9 and 24 hours post first intervention meal.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Serum concentration of lutein and beta-carotene

时间窗: 15 days

Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.

次要结局

  • Concentration of lutein and beta-carotene in the chylomicron/TLR fraction(24 hours)
  • Concentration of other carotenoids in the chylomicron/TLR fraction(24 hours)
  • Level of optical density of the macula lutea(Baseline)
  • Total lutein and beta-carotene sekretion with feces/ileostomy-efflux(48/24 hours)
  • Serum concentration of other carotenoids(15 days)
  • Serum concentration of other fat-soluble vitamins(15 days)
  • Changes in metabolic markers(15 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Lars Ove Dragsted

Professor

University of Copenhagen

研究点 (4)

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