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临床试验/NCT02837107
NCT02837107Unknown不适用

Study of Supplement's Antioxidant Properties That Contains Natural Extracts

Harokopio University0 个研究点目标入组 62 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
62
主要终点
Change from Baseline of anti-oxidant enzymes activity at 4 weeks

研究概览

简要总结

While it is well accepted that a low level of RONS production is necessary to maintain physiological function, too much formation of RONS are believed to participate in biomolecules damage. Damage of lipids, proteins and DNA/RNA, to cellular and tissue level, as a consequence of oxidative stress has been linked to a number of serious diseases, including cancer, cardiovascular diseases (CVDs) such as hypertension and atherosclerosis, neurodegenerative diseases such as Parkinson's disease and Alzheimer's dementias, diabetes and the process of aging.

The dietary intake of antioxidants is thought to play a major role in oxidative stress network. Many epidemiologic studies have reported an inverse association between vegetable and fruit consumption with reduced risk of chronic diseases, especially cancer and CVDs. However, although many clinical trials have been conducted with vitamins (E, C or their combinations) their in vivo protective effect remains uncertain. Therefore the possibility that the complex mixture of phytochemicals in foods may contribute to their protecting effects has been raised. In this concept, it is possible multiple compounds to act through complimentary or synergistic mechanisms to present a greater biologic effect than can be achieved by any individual component To investigate this hypothesis, a double-blind, randomized, and placebo-controlled clinical trial was conducted in order to investigate the effects of a multi-micronutrient supplement against oxidative stress in apparently healthy adults.

详细描述

This was a double-blind, block randomized, parallel-arm, placebo-controlled, eight-week study. Initially 77 apparently healthy volunteers were recruited to participate in the study. 62 volunteers were enrolled in the study and assigned to either the MM group (n = 32) or the placebo group (n = 30) using a stratified randomization to guarantee comparability of age, sex and BMI distribution between the two groups. The randomization code was prepared by a staff member who was not involved in running the trial, by using computer-generated random numbers. At the initiation of the study, the subjects received 5 bottles (0.5L each) of the MM or placebo, which were made indistinguishable by their identical packaging. At 4 weeks the subjects received again 5 bottles. The subjects were asked to consume 80mL per day, preferably after meals. The dose was chosen based on the commercially recommended level. At each visit, the remaining volume of the supplement was counted by research coordinators. The subjects were excluded from the analysis if they consumed <80% of the recommended dose.

研究设计

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

入排标准

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

入选标准

  • •BMI: 23-30

排除标准

  • •regular use of dietary supplements or medications
  • •being on slimming or any other special diet
  • •hypertension
  • •metabolic or endocrine disease
  • •gastrointestinal disorders
  • •recent history of medical or surgical events

研究组 & 干预措施

Supplement

Active Comparator

The supplement (Mind Master) were custom prepared and donated by LR Healthy and Beauty Systems LTD. The supplement contained per 80ml, aloe barbadensis miller gel (USA/Mexico 36%), grape juice, Polygonum cuspidatum extract (that contain 10% resveratrol), green tea extract, 1.1 mg vitamin B1 (100% RDA), 2.5 µg vitamin B12 (100% RDA), 12 mg vitamin E (α - ΤΕ) (100% RDA), coenzyme Q10, 200 µg folic acid (100% RDA), ascorbic acid, 27.5 µg selenium (100% RDA), 4.2 mg iron (100% RDA).

干预措施: Mind Master (Dietary Supplement)

Placebo

Placebo Comparator

A look-alike placebo were prepared and donated by LR Healthy and Beauty Systems LTD. The placebo contained Aloe barbadensis Miller Gel (USA/Mexico 3.6%), ascorbic acid, and some excipients.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Change from Baseline of anti-oxidant enzymes activity at 4 weeks

时间窗: 0, 4 weeks

serum

Change from Baseline of TBARS levels at 8 weeks

时间窗: 0, 8 weeks

serum

Change from Baseline of DNA/RNA damage at 8 weeks

时间窗: 0, 8 weeks

urinary DNA/RNA damage

Change from Baseline of protein carbonyls levels at 4 weeks

时间窗: 0, 4 weeks

serum

Change from Baseline of protein carbonyls levels at 8 weeks

时间窗: 0, 8 weeks

serum

Change from Baseline of oxLDL levels at 4 weeks

时间窗: 0, 4 weeks

serum

Change from Baseline of isoprostane levels at 4 weeks

时间窗: 0, 4 weeks

urinary isoprostane

Change from Baseline of isoprostane levels at 8 weeks

时间窗: 0, 8 weeks

urinary isoprostane

Change from Baseline of DNA/RNA damage at 4 weeks

时间窗: 0, 4 weeks

urinary DNA/RNA damage

Change from Baseline of serum resistant in oxidation at 8 weeks

时间窗: 0, 8 weeks

ex vivo serum oxidation with cupper

Change from Baseline of oxLDL levels at 8 weeks

时间窗: 0, 8 weeks

serum

Change from Baseline of TBARS levels at 4 weeks

时间窗: 0, 4 weeks

serum

Change from Baseline of serum resistant in oxidation at 4 weeks

时间窗: 0, 4 weeks

ex vivo serum oxidation with cupper

Change from Baseline of anti-oxidant enzymes activity at 8 weeks

时间窗: 0, 8 weeks

serum

次要结局

  • Change from Baseline of Platelet aggregation against PAF at 8 weeks(0, 8 weeks)
  • Change from Baseline of Platelet aggregation against ADP at 8 weeks(0, 8 weeks)
  • Change from Baseline of Platelet aggregation against TRAP at 8 weeks(0,8 weeks)
  • Change from Baseline of Platelet aggregation against PAF at 4 weeks(0, 4 weeks)
  • Change from Baseline of Platelet aggregation at against ADP 4 weeks(0, 4 weeks)
  • Change from Baseline of Platelet aggregation against TRAP at 4 weeks(0, 4 weeks)
  • Change from Baseline of Inflammatory markers at 4 weeks(0, 4 weeks)
  • Change from Baseline of Inflammatory markers at 8 weeks(0,8 weeks)

研究者

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

Elizabeth Fragopoulou

Assistant Professor of Biological Chemistry

Harokopio University

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