Short-term Supplementation, Bone Turnover and Antioxidant Status in Postmenopausal Stage: A Placebo Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Antioxidant status
研究概览
简要总结
This is a 8-week, double-blinded, placebo-controlled, randomized intervention trial to investigate the effects of Mg and Zn supplementation on antioxidant status and bone hormonal parameters. Participants were randomly assigned to one of three treatment groups: Placebo group (PbG: 25 women); Magnesium Group - 500 mg/day of Mg (MgG: 27 women); Zinc Group - 50 mg/day of Zn (ZnG: 26 women).
详细描述
Seventy-eight healthy postmenopausal volunteers aged between 44 and 76 were recruited once had been informed about the protocol. This is a 8-week, double-blinded, placebo-controlled, randomized intervention trial to investigate the effects of Mg and Zn supplementation on antioxidant status and bone hormonal parameters. Participants were randomly assigned to one of three treatment groups: Placebo group (PbG: 25 women); Magnesium Group - 500 mg/day of Mg (MgG: 27 women); Zinc Group - 50 mg/day of Zn (ZnG: 26 women).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 44 Years 至 76 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •to present postmenopausal status (with at least 12 months of amenorrhea)
- •to present low status in Mg and/or Zn obtained in a previous biochemical assessment
- •not present any pathology that could affect their nutritional status
- •not to be subjected to hormone replacement therapy (HRT)
- •not to demonstrate lactose intolerance
- •Exclusion criteria
- •acute or terminal illness
- •unwillingness to either complete the study requirements or to be randomised into control or experimental group
- •to be smoker
- •to be on a medication regimen
排除标准
- 未提供
研究组 & 干预措施
Placebo Supplemented Group
Placebo control
干预措施: Placebo Comparator (Dietary Supplement)
Magnesium Supplemented Group
Magnesium Group
干预措施: Magnesium supplement (Dietary Supplement)
Zinc Supplemented Group
Zinc Group
干预措施: Zinc Supplement (Dietary Supplement)
结局指标
主要结局
Antioxidant status
时间窗: 2 months
Total antioxidant capacity (TAC) determination in plasma samples was carried out evaluating the reduction power of Cu2+ from the action of antioxidants present in samples (TAC kit, Jaica, Shizuoka, Japan). Values were expressed in umol/L.
Oxidative stress
时间窗: 2 months
Glutathione peroxidase (GPx) in mU/mL and Superoxide dismutase (SOD) in U/mL. GPx activity was determined by using the Bioxytech GPx-340™ kit (OxisResearch™), an indirect colorimetric assay of the activity of c-GPx \[28\]. SOD activity was determined by using the Randox Ransod kit (RANDOX Laboratories Ltd., United Kingdom).
次要结局
- Anthropometric assessment - Height(2 months)
- Anthropometric assessment - Waist circumference(2 months)
- Anthropometric assessment - Body composition by bioelectrical impedance(2 months)
- Intake assessment(2 months)
- Biochemical parameters - Clinical-nutritional parameters(2 months)
- Hormonal parameters(2 months)
研究者
Elena Planells del Pozo
University Professor
Universidad de Granada