NCT03580447已完成不适用
The Effect of Citrus Extract Administration on Markers of Oxidative Stress in Elderly Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Oxidative stress
研究概览
简要总结
This randomized, cross-over, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 4 weeks on markers of oxidative stress in elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals
- •Age 70-85 years
- •BMI < 30 kg/m2
排除标准
- •History or actual status of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- •Disease with a life expectancy shorter than 5 years
- •Institutionalized (e.g. hospital or nursing home).
- •Subjects with abnormalities in haematology which may interfere with the endpoints of the study (to be decided by the principle investigator)
- •Use of drugs or hormones within 3 months prior to the start of the study which may interfere with the endpoints of the study (to be decided by the principle investigator)
- •Self-admitted Inflammation, (viral) infection (e.g. HIV or hepatitis B)
- •Subjects with an autoimmune disease (e.g. Rheumatoid arthritis)
- •Subjects with intestinal disorders which may interfere with the endpoints of the study (to be decided by the principle investigator)
- •Use of immunosuppressive drugs within 3 months prior to the start of the study
- •Use of medication (e.g. NSAIDs), antibiotics or corticosteroids which may interfere with the endpoints of the study (to be decided by the principle investigator)
- •Changes in medication that may significantly affect the study outcome (according to the investigator's judgment) within 1 month prior to the start of the study.
- •Use of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days before the study
- •Use of (dietary) supplements containing antioxidants, vitamins and minerals
- •Weight gain or loss (> 3 kg in the previous 3 months)
- •Excessive intake of foods with a high polyphenol concentration
- •Use of pre-, pro or synbiotics within 1 month prior to the start of the study
- •Blood donation within 1 month prior to the start of the study
- •Excessive alcohol consumption (>20 alcoholic consumptions per week)
- •History of any side effects towards the intake of flavonoids or citrus fruits
结局指标
主要结局
Oxidative stress
时间窗: Change from baseline to four weeks supplementation, of each intervention period
Oxidative stress, as measured by blood biomarkers
次要结局
未报告次要终点
研究者
Yala Stevens
MSc.
Maastricht University Medical Center
研究点 (2)
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