NL-OMON48468已完成不适用
Exploratory Biomarker Study of Fatty Acid profiles in Healthy Volunteers and patients with Parkinson's Disease - Fatty Acid profiles in Healthy Volunteers and Parkinson*s Disease
Yumanity0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Healthy male or female subjects 35-80 years of age, inclusive. Healthy
- •status is defined by absence of evidence of any active acute or chronic disease
- •or illness following a detailed medical and surgical history, a complete
- •physical examination including vital signs, 12-lead ECG, hematology, blood
- •chemistry and urinalysis; deemed by the investigator to be clinically
- •significant;
- •OR: Male or female subjects 40-75 years of age, with a confirmed diagnosis of
- •Parkinson*s disease (Hoehn and Yahr grade 1-4) inclusive;
- •2. Body mass index (BMI) between 18-35 kg/m2, inclusive, and with a minimum
- •weight of 50kg and maximum weight of 120kg;
- •3. Evidence of a personally signed, dated and witnessed informed consent
- •document indicating that the subject has been informed of all pertinent aspects
- •of the study;
- •4. Able and willing to give written informed consent and to comply with any and
- •all study restrictions.
排除标准
- •1. Legal incapacity or inability to understand or comply with the requirements
- •of the study;
- •2. Clinically significant findings as determined by medical history taking,
- •physical examination, ECG and vital signs, which, in the opinion of the
- •Investigator, does not allow study participation.
- •3. Any current, clinically significant, known medical condition other than
- •Parkinson*s disease. Patients with a diagnosis of other neurological diseases,
- •including Alzheimer*s disease, Huntington*s disease, vascular dementia,
- •epilepsy, etc., will not be eligible for this study.
- •4. Have a urine drug screen detecting illicit drug(s) of abuse (morphine,
- •benzodiazepines, cocaine, amphetamine, THC, methamphetamine, MDMA) or positive
- •alcohol breath test at screening, with exception of positive urine drug screens
- •caused by prescribed drugs, such as benzodiazepines for PD sleeping disorders;
- •5. Consume, on average, >8 units/day of (methyl)xanthines (e.g., coffee, tea,
- •cola, chocolate);
- •6. History or clinical evidence of alcoholism or drug abuse;
- •7. Smoking of >5 cigarettes/day or equivalent;
- •8. Use of prescription, illicit or herbal medication within 7 days of study
- •initiation, except for contraception or their current standard of care
- •medications for the treatment of parkinsonism;
- •9. Simultaneous participation in a clinical trial more than 4 times in the
- •previous year;
- •10. Being on a diet composed of relevantly altered amounts of fat, protein or
- •carbohydrates that may affect triglyceride and fatty acid levels.
- •11. Loss of blood * 500ml within 3 months before screening
研究者
相似试验
招募中
4 期
Study of factors associated with fatty acid in the blood of hemodialysis patients :cross-sectional study and cross-over study with EPA ethyl ester.JPRN-UMIN000006806Dialysis Division, University of Miyazaki Hospital150
尚未招募
不适用
Effect of using sunflower versus groundnut oil on glycemic and lipid profile among overweight Indian adults.CTRI/2020/10/028703Indian Council of Medical Research
尚未招募
不适用
octurnal free fatty acids. Measurements in obese and lean subjects and the effect of beta-blockage on pulsatile release.10018424insulin resistanceNL-OMON32829Academisch Medisch Centrum20
已完成
不适用
Plasma Free Fatty Acids Profile As A Diagnostic Tool For Acute Ischemic StrokeStroke, AcuteNCT03618290Sanford Health102
已完成
不适用
Fatty Acid Biomarkers of Carbohydrate IntakeDyslipidemiasNCT03295448Uppsala University19