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临床试验/NCT03020680
NCT03020680已完成1 期

The Effect of Redox Status on Bioavailability of Ubiquinone and Ubiquinol in 10 Older Adults

Tufts University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
2
主要终点
Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells

研究概览

简要总结

Coenzyme Q10 (or CoQ10) is a marketed supplement in US even though it can be synthesized in the body via complicated biochemical pathways. It exists in both reduced and oxidized states, namely ubiquinol and ubiquinone, respectively. It is commonly present in all cell membranes. The main function of CoQ10 is to participate in energy production. Further, the reduced form of CoQ10, ubiquinol, is appreciated as an important lipophilic antioxidant to protect free radical induced damages to DNA, lipid, and proteins. Given that older adults have increased production of free radicals, suboptimal antioxidant defenses toward free radicals, and a decreased capability to replenish utilized CoQ10, CoQ10 supplementation can be one of feasible ways to increase CoQ10 status in order adults. Most supplements available for consumers are in the oxidized form. While the ubiquinol form is also available, whether the reduced form will be more effective to replenish CoQ10 status in older subjects remains to be explored. Thus, investigators aimed to examine whether ubiquinol will be more effectively absorbed in older adults with a low antioxidant defense status. To pursue this aim, investigators will conduct a double blind, randomized, crossover design trail with 5 study visits (1 screening visit and 4 study visits). Ten older men (>55 y, BMI: 25-5 kg/m2) with a compromised antioxidant defenses will be recruited and complete the trial. Eligible subjects will be randomized to receive 200 mg/d ubiquinol or ubiquinone for 2 weeks with 2-week washout between crossover. Ubiquinol and ubiquinone in plasma and immune cells in blood will be assessed to reveal whether the reduced form, ubiquinol, is more absorbable than the oxidized form, ubiquinone in older adults.

详细描述

Coenzyme Q10 (or CoQ10) is a marketed supplement in US even though it can be synthesized in the body via complicated biochemical pathways. It exists in both reduced and oxidized states, namely ubiquinol and ubiquinone, respectively. It is commonly present in all cell membranes. The main function of CoQ10 is to participate in energy production. Further, the reduced form of CoQ10, ubiquinol, is appreciated as an important lipophilic antioxidant to protect free radical induced damages to DNA, lipid, and proteins. Given that older adults have increased production of free radicals, suboptimal antioxidant defenses toward free radicals, and a decreased capability to replenish utilized CoQ10, CoQ10 supplementation can be one of feasible ways to increase CoQ10 status in order adults. Most supplements available for consumers are in the oxidized form. While the ubiquinol form is also available, whether the reduced form will be more effective to replenish CoQ10 status in older subjects remains to be explored. Thus, investigators aimed to examine whether ubiquinol will be more effectively absorbed in older adults with a low antioxidant defense status. To pursue this aim, investigators will conduct a double blind, randomized, crossover design trail with 5 study visits (1 screening visit and 4 study visits). Ten older men (>55 y, BMI: 25-5 kg/m2) with a compromised antioxidant defenses will be recruited and complete the trial. Eligible subjects will be randomized to receive 200 mg/d ubiquinol or ubiquinone for 2 weeks with 2-week washout between crossover. Ubiquinol and ubiquinone in plasma and immune cells in blood will be assessed to reveal whether the reduced form, ubiquinol, is more absorbable than the oxidized form, ubiquinone in older male adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
56 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age: >55 and <76 y
  • BMI: ≥25 and <35 kg/m2
  • Willing to take the assigned supplement for 4 weeks
  • Willing to maintain dietary habit for 6 week
  • <1000 µmol/L Fe2+ plasma total antioxidant capacity determined by Ferric Reducing Antioxidant Power and <400 µmol/L total thiol content in plasma

排除标准

  • Regular use of any dietary supplements containing vitamins and minerals; however, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their enrollment and throughout the entire study may be considered eligible; subjects will be excluded if they are taking physician prescribed vitamin and/or mineral supplements
  • Use of medications known to affect lipid metabolism
  • Gain or loss of ≥5% of body weight in the last 6 mo
  • Impaired gastrointestinal, renal, and endocrine functions, diseases, conditions or medications influencing gastrointestinal absorption
  • Unusual dietary pattern, including vegan/vegetarian
  • Active treatment for cancer of any type longer than 1 year.
  • Daily alcoholic intake of more than 14 drinks/week (168 oz. beer, 56 oz. wine, 14 oz. hard liquor)
  • Values of standard blood biochemistries are critically abnormal based on study physician's

研究组 & 干预措施

ubiquinone

Active Comparator

It is the oxidized form of coenzyme Q10

干预措施: Coenzyme Q10 (Dietary Supplement)

ubiquinol

Experimental

It is the reduced form of coenzyme Q10

干预措施: Coenzyme Q10 (Dietary Supplement)

结局指标

主要结局

Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells

时间窗: before and after the 2-week supplementation of coenzyme Q10

Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells before and after the 2-week supplementation of coenzyme Q10

次要结局

  • Concentration change of ubiquinol and ubiquinone in plasma(before and after the 2-week supplementation of coenzyme Q10)

研究者

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

Oliver Chen

Scientist I

Tufts University

研究点 (2)

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