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临床试验/NCT05319548
NCT05319548已完成不适用

Plant Pigments for Human Health: Determining the Interactions the Impact of Co-ingestion of Carotenoids and Anthocyanins From Multicolored Carrots on the Bioavailability of Provitamin A Carotenoids and the Impact on Each Pigment Groups' Respective Antidiabetic Activity in Humans

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Change in serum retinol concentration

研究概览

简要总结

The proposed research will help characterize the impact that simultaneous consumption of anthocyanins and carotenoids has on the bioavailability of the provitamin A carotenoids a-carotene and b-carotene and the non-provitamin A carotenoid lycopene, and on their respective antidiabetic activity in humans. The central hypothesis is that provitamin A carotenoids will be bioavailable from purple-red multicolored carrots in humans, and the co-ingestion of carotenoids and anthocyanins from these carrots will have synergistic impacts on their respective antioxidant and antidiabetic effects. This hypothesis will be assessed through a 53 day randomized crossover time course study that consists of three arms in which healthy males and females ages 18-40 (n = 12) will consume carrot juice prepared from red, purple-red, or purple carrots. During each arm, participants will switch the type of juice they consume and by the end of the third arm, all participants will have ingested juice made from all three carrot varieties. Blood will be collected at multiple time points over 72 hours following consumption.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Non-smoking
  • Not pregnant (or planning to become pregnant)
  • Body Mass Index (BMI) greater than 18.5 and less than 30

排除标准

  • Major comorbidities (cardiovascular disease (CVD), diabetes, cancer, kidney/liver/bowel disease)
  • History of malabsorptive/GI disorders
  • Abnormal diet
  • BMI less than 18.5 or greater than 30
  • Food intolerances/allergies/hypersensitivities
  • History of substance abuse or alcoholism
  • Unwilling to restrict consumption of specific foods prior to study
  • Unwilling to participate in blood draws
  • History of difficulty drawing blood/health issues associated with blood draws (gets dizzy, etc).

结局指标

主要结局

Change in serum retinol concentration

时间窗: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours

Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)

Change in serum carotenoid concentration

时间窗: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours

Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)

Change in serum anthocyanin concentration

时间窗: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours

Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)

次要结局

  • Change in serum glucose concentration(Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours)
  • Change in antioxidant capacity of the carrots and carrot juice measured by enzyme activity assay(up to 1 month)
  • Change in alpha-glucosidase inhibition activities of the carrots and carrot juice measured by enzyme activity assay(up to 1 month)
  • Change in serum incretin concentration(Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours)
  • Change in alpha-amylase inhibition activities of the carrots and carrot juice measured by enzyme activity assay(up to 1 month)
  • Change in serum insulin concentration(Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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