ISRCTN25890011进行中（未招募）未知
A randomised, double-blind, placebo-controlled pilot study investigating the effects of 12 weeks ergothioneine supplementation on serum oxidative, inflammatory, and metabolic markers in people with metabolic syndrome
niversity of Leeds0 个研究点目标入组 108 人开始时间: 2021年2月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participants must be 18-70 years old, overweight or obese, and have risks of metabolic syndrome, defined by presenting with at least two of the six following criteria:
- •1. BMI >25 kg/m²
- •2. Abdominal obesity: high waist circumference (Asian/Asian British - men =90 cm; women =80 cm; White and all other ethnic groups - men =94 cm, women =80 cm)
- •3. Fasting glucose =100 mg/dl (5.6 mmol/l) or treatment for elevated blood glucose
- •4. Blood pressure =130/85 mmHg or treatment for elevated blood pressure
- •5. Triglycerides =150 mg/dl (1.7 mmol/l) or treatment for elevated triglycerides
- •6. Cholesterol-high density lipoprotein (HDL-C) < 40 mg/dl (1.0 mmol/l) for male or < 50 mg/dl (1.3 mmol/l) for female or treatment for low HDL-C
排除标准
- •1. Participants who are under 18 years old or over 70 years
- •2. Women who are pregnant or lactating
- •3. Participants who smoke
- •4. Participants who consume =28 units of alcohol per week (28 units = ~10 medium glasses of wine (175 mL) or ~10 pints of beer/cider)
- •5. Participants who have taken dietary/antioxidant supplements within the last 4 months (adequate washout period)
- •6. Participants who have newly implemented a diet or exercise regime (=150 min/week moderate aerobic exercise or =75 min/week vigorous aerobic exercise) aimed at weight loss
- •7. Participants who have gained or lost weight of >3 kg or more in last month
- •8. Participants who are following lifestyle change advice
- •9. Diagnosis of liver disease, diabetes, heart disease, kidney disease or intestinal disorders (Crohn’s disease, short bowel syndrome, pancreatic insufficiency, cystic fibrosis, tropical sprue, Whipple's disease, chronic pancreatitis, gastrojejunostomy, surgical treatment for obesity, cholestasis, biliary atresia, parasitic infections)
- •10. Diagnosis of cancer or end of cancer treatment within 2 years
- •11. Participants taking prescription anti-inflammatory medicines (occasional aspirin, paracetamol, ibuprofen use acceptable)
- •12. Participants who have been diagnosed with a blood borne disease (HepB, HIV etc.)
- •13. Participants receiving antibiotic treatment within last month or 3 courses within the last 6 months
- •14. Participating in other clinical trials that may influence outcomes
- •15. Participants who are impaired in cognition or cannot complete the trial independently
- •16. Participants who have difficulties in understanding written and/or verbal English
- •17. Participants who cannot come to the University
- •18. Participants who are unwilling or unable to provide informed consent
- •19. Participants who can not wear a face mask during the visit
研究者
相似试验
进行中（未招募）
1 期
The Oxford Marfan TrialEUCTR2010-023612-14-GBClinical Trials and Research Governance56
招募中
2 期
Effect of centhaquine on cardiovascular parameters in patients with hypovolemic shock.CTRI/2023/12/060444Aman Hospital and Research Centre
进行中（未招募）
1 期
A Randomized pilot study to evaluate the safety and efficacy of Cinryze (C1-Esterase Inhibitor (human)) for the treatment of graft rejection in kidney transplant patientsEUCTR2012-000441-12-DEVIROPHARMA Incorporated20
已完成
2 期
Alendronate for the prevention of osteoporosis in ankylosing spondylitisAnkylosing spondylitis.Ankylosing spondylitisIRCT201212206975N3Vice chancellor for research, Tabriz University of Medical Sciences20
进行中（未招募）
不适用
A Randomized, double-blind, placebo-controlled pilot study of KB001 in mechanically-ventilated patients colonized with pseudomonas aeruginosaEUCTR2007-006764-29-FRKaloBios Pharmaceuticals, Inc.