Effects of Supplementation With Flaxseed Oil and Pomegranate Extract on Inflammation Markers, Lipid Profile and Nutritional Status of Individuals on Hemodialysis: a Randomized, Placebo-controlled, Triple-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- interleukin 2
研究概览
简要总结
Nutritional and metabolic alterations in patients with chronic kidney disease (CKD) such as inflammation, oxidative stress, dyslipidemia, and poor nutritional status which associate with poor clinical outcome can potentially be targeted and ameliorated by interventions using nutritional supplements. The investigators evaluated the effects of 8 weeks of oral supplementation with flaxseed oil and pomegranate dry extract on markers of inflammation, lipid profile and nutritional status of individuals undergoing hemodialysis (HD).
The goal of this randomized, placebo-controlled, double-blind clinical trial is to evaluate the effects of 8 weeks of oral supplementation with flaxseed oil and pomegranate dry extract on markers of inflammation, lipid profile and nutritional status of individuals undergoing hemodialysis (HD).
Participants will be randomly assigned, in a 1:1 ratio, to supplementation group to receive twice a day 1 capsule of 1.000 mg of flaxseed oil plus 1 capsule of 600mg of pomegranate dry extract; or to placebo group, to receive twice a day 1 capsule of 1.000 mg of sunflower oil plus 1 capsule of 600mg of microcrystalline celulose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 19 years; have a diagnosis of CKD;
- •perform HD three times a week for a period of ≥ three months;
- •acceptance of participation.
排除标准
- •history of allergy to flaxseed or pomegranate;
- •infection or hospitalization in the beginning or during the course of the study;
- •HIV seropositivity and active malignancy;
- •pregnancy or breastfeeding.
结局指标
主要结局
interleukin 2
时间窗: Change from Baseline and at 8 weeks (end of study)
tumor necrosis factor alpha
时间窗: Change from Baseline and at 8 weeks (end of study)
interferon-gamma
时间窗: Change from Baseline and at 8 weeks (end of study)
C-reactive protein
时间窗: Change from Baseline and at 8 weeks (end of study)
interleukin 10
时间窗: Change from Baseline and at 8 weeks (end of study)
interleukin 6
时间窗: Change from Baseline and at 8 weeks (end of study)
interleukin 4
时间窗: Change from Baseline and at 8 weeks (end of study)
次要结局
- low-density lipoprotein(Change from Baseline and at 8 weeks (end of study))
- total cholesterol(Change from Baseline and at 8 weeks (end of study))
- high-density lipoprotein(Change from Baseline and at 8 weeks (end of study))
- triglycerides(Change from Baseline and at 8 weeks (end of study))
研究者
Aline Miroski de Abreu
Principal investigator
Santa Catarina Federal University