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临床试验/NCT04914312
NCT04914312已完成不适用

Beneficial Effects of Maqui Berry Extract Combination With Omega-3 Fatty Acids on Cytokine Reduction in Elderly Obese Adults

Arizona State University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月15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
32
试验地点
2
主要终点
Tumor Necrosis Factor (TNF)

研究概览

简要总结

The purpose of this trial is to determine the effect of maqui extract plus omega-3 fatty acids compared to a placebo for reducing inflammatory cytokine levels in older, obese adults.

详细描述

Anthocyanins, a subclass of flavonoids, are plant pigments that provide the rich color of many plants, fruits, and flowers. Health benefits of anthocyanins have been widely reported in the research literature, particularly for disease conditions associated with oxidative stress, such as cardiovascular and neurodegenerative diseases. Emerging evidence suggests that anthocyanins may also modulate gut microbiota, which can impact a wide variety of health conditions. Maqui berries (Aristotelia chilensis), indigenous to Chile, have one of the highest concentrations of anthocyanins in the plant world; moreover, the dominant anthocyanin in maqui berries is delphinidin. Delphinidin is more bioavailable than most flavonoids, with intact molecules absorbed in appreciable amounts in less than an hour after consumption. Systemic effects of delphinidin include reduced inflammation due to downregulation of NF-kB, the transcription factor that initiates the generation of pro-inflammatory cytokines. The omega-3 fatty acid eicosapentaenoic acid [EPA], a component of omega-3 fatty acid concentrates, also has anti-inflammatory properties. There is much empirical evidence demonstrating beneficial effects of EPA supplementation, linked mainly to reductions in inflammation. It has been demonstrated the dietary supplementation with EPA-rich marine oil concentrations reduces cytokine levels up to 15%.

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
Double (Participant, Investigator)

盲法说明

Experimental capsules matched to placebo capsules

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females 50-85 years old
  • Generally healthy, non-smoker
  • Able to provide informed consent
  • BMI: 30-40 kg/m2

排除标准

  • Existing auto-immune conditions
  • Use of warfarin or other blood thinners
  • Use of anti-inflammatory drugs, cardiovascular medications, lipid-altering drugs, and hormone replacement therapy
  • Individuals engaged in vigorous exercise (>2 x 30 min/week), vegetarians, and people who routinely take multivitamins or herbal supplements.

结局指标

主要结局

Tumor Necrosis Factor (TNF)

时间窗: change from baseline at day 56

Blood concentration of TNF

Interleukin-6 (IL-6)

时间窗: change from baseline at day 56

Blood concentrations of IL-6

Interleukin-1 beta (IL-1 beta)

时间窗: change from baseline at day 56

Blood concentration of IL-1 beta

次要结局

  • Arachidonic acid (AA)(change from baseline at day 56)
  • Eicosapentaenoic acid (EPA)(change from baseline at day 56)

研究者

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

Carol Johnston

Professor and Associate Dean

Arizona State University

研究点 (2)

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