NCT02871271撤回不适用
Open-Label Pilot Study to Evaluate the Tolerability and Benefit of IQP-AS-121 on Fatigue and Mental Alertness in Healthy Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in VAS-F parameter
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and benefit of IQP-AS-121 on reducing fatigue and tiredness and to improve mental alertness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian males and females, 21-55 years of age
- •Body mass index (BMI) 18.5-29.9 kg/m2
- •Generally in good health without clinically significant findings at screening
- •No chronic fatigue syndrome according to the Fukuda Centres for Disease Control and Prevention (CDC) criteria at screening
- •Subjective feeling of chronic stress and tiredness for 3-12 last months prior to screening
- •Screening Scale of Chronic Stress (SSCS) score >18
- •Fatigue Severity Scale score >4
- •≤ 3 cups/portions of coffee and/or caffeine-containing food/beverages per day in the 3 last months prior to screening and during the study
- •Regular stable continuous level of daily activities
- •Regular sleep-wake cycle
- •Normal dietary habits according to investigator's judgement
- •≤ moderate level of physical exercise
- •Readiness to comply with study procedures, in particular:
- •Consumption of the IP during the treatment period
- •Filling in all questionnaires
- •Keep habitual diet and level of physical exercise
- •No change in smoking habits during the study
- •Women of child-bearing potential only:
- •negative pregnancy testing (ß-HCG in urine at screening)
- •commitment to use reliable contraception methods during the entire study Participation is based upon written informed consent form (ICF) by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
排除标准
- •Known sensitivity to any components of the IP
- •Any medical condition associated with tiredness (e.g. iron deficiency, hypotension etc.)
- •History and/or presence of clinically significant disease, which per investigator's judgement could interfere with the results of the study or the safety of the subject:
- •Psychiatric diseases, e.g. depression, schizophrenia
- •Eating disorders such as anorexia
- •Untreated or non-stabilized metabolic diseases, e.g. diabetes mellitus
- •Untreated or non-stabilized thyroid disorder
- •Untreated or non-stabilized hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg)
- •Significant gastrointestinal diseases
- •Known bleeding disorders such as haemophilia
- •Any other known significant or serious condition / disease that renders subjects ineligible (e.g. history of malignancy within the past 5 years prior to screening, any clinically significant cardiovascular, renal, liver disease etc.)
- •Use of medication which in the investigator's judgement could interfere with the results of the study (e.g. psychoactive medication, statins, proton pump inhibitors, blood-pressure medications, antihistamines, antibiotics, diuretics) within the last 4 weeks prior to screening and during the study
- •Consumption of vitamins, nutritional supplements, supplementary balanced diet, mineral products which in the investigator's judgement could interfere with the results of the study within last 4 weeks prior to screening and during the study
- •Consumption of adaptogens (e.g. ginseng or Schisandra) or St. John's Wort within last 4 weeks prior to screening and during the study
- •Consumption of energy drinks during the study
- •Start of use of contraception medication during the last 3 months prior to screening and during the study
- •Use of anticoagulants such as warfarin
- •Clinically significant deviation of laboratory parameters and/or deviations > 2 x ULN (upper limit of normal) at screening
- •Recent or current significant stressors (e.g. active grieving)
- •Chronic pain
- •Chronic sleep deficiency (< 5 hours/night)
- •Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- •Participation in another study during the last 30 days prior to screening
- •Women of child-bearing potential: pregnant or breastfeeding
- •Any situation expected during the study causing acute high level of stress
- •Any other reason deemed suitable for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
结局指标
主要结局
Change in VAS-F parameter
时间窗: 6 weeks
Compared between timepoints week 6 versus baseline - To assess fatigue and energy with 18 items which possesses two subscales: fatigue (13 items) and energy (5 items).
次要结局
- Change in Bond & Lader VAS parameter(6 weeks)
- Change in FAIR-2(6 weeks)
- Global evaluation of benefit(6 weeks)
- Adverse events(6 weeks)
- Change in SF-12 parameter(6 weeks)
- Change in Number Connection Test(6 weeks)
- Change in PSQ20 parameter(6 weeks)
- Change in POMS-35 parameters(6 weeks)
- Global evaluation of tolerability(6 weeks)
研究者
研究点 (2)
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