NCT02873910已完成不适用
Randomized, Double-Blind, Placebo-Controlled, Monocentric, Parallel-Group Study to Evaluate the Influence of IQPAS-119 on Post-Marathon Susceptibility to Infections and Influence on Other Complaints and Its Tolerability: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Hooper's Index
研究概览
简要总结
The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-119 for reduction of susceptibility to infections and other complaints after extreme physical stress (participation in a marathon).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian males and females, 18-65 years of age, residents of Berlin or Brandenburg
- •Body mass index (BMI) 18.5-26.0 kg/m2
- •Registered as runner for the 43rd BMW Berlin Marathon 2016
- •History of at least 2 successful finished marathons (personal record of 3-5.5h within the last 5 years)
- •History of post-exercise susceptibility to infections (e.g. upper respiratory tract symptoms) and/or other health conditions (infections, stress complaints) after strenuous exercise (eg. marathon, half-marathon, bicycle races, triathlons, heavy training loads) within the last 5 years (to be distinctly documented at screening)
- •Readiness to comply with all study procedures, in particular:
- •Consumption of the investigational product (IP) during the entire treatment period of the study
- •Maintaining the habitual diet, with the exception of consumption of maximal 2 garlic cloves per week
- •Adapt pre-marathon training / physical activity to generally accepted proven or individually successful training plan
- •Adapt post-marathon training / physical activity to generally accepted proven or individually successful recovery plan
- •Filling in diaries and questionnaires
- •Readiness to ensure generally proven or individually successful optimal food intake and rehydration before, during, and after the marathon.
- •Non-smoker / smoking cessation of last ≥12 months prior to screening
- •Regular sleeping pattern (no suspicion of sleep disorder) in the three months prior to screening
- •Stable concomitant, permitted medication (if any) for at least last 2 weeks prior to screening and during the study
- •Women of child-bearing potential only:
- •negative pregnancy testing (Beta human chorionic gonadotropin (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 ingredients of the IP
- •Additional strenuous exercise/activity other than regular occupational load, completing training runs / exercises prior the marathon. Additional strenuous exercise/activity other than regular occupational load and recovery exercise loads after the marathon
- •History of severe cardiovascular disease or collapse during a running event (half marathon, marathon etc.) and/or training
- •Hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg)
- •Any abnormality observed in screening exercise ECG pointing to an increased cardiovascular risk (alternatively: any abnormality in the results of an exercise ECG performed in the last 6 weeks prior to screening pointing to an increased cardiovascular risk)
- •Any chronic disease affecting the upper respiratory tract and the lungs, eg. asthma bronchial, chronic obstructive pulmonary disease, or ears-nose-throat (ENT) infection
- •Acute infection of ENT or upper respiratory tract (URT) within the last month prior to screening
- •Any nasal abnormalities:
- •History of nasal reconstructive surgery
- •Severe nasal septum deviation or other condition that could cause nasal obstruction
- •Presence of nasal ulcers or nasal polyps
- •Active organ or systemic diseases including severe cardiovascular disease, diabetes mellitus, renal or liver disorder
- •Known congenital or acquired immunodeficiency disease (e.g. HIV infection)
- •Known bleeding disorders such as bleeding ulcers, or haemophilia
- •Vaccination against influenza within 3 months prior to screening; any vaccination planned during the study
- •Anticoagulants such as warfarin
- •Systemic analgesics (other than paracetamol up to 2000mg/day or ibuprofen up to max. 800 mg/day, or if medically indicated and prescribed by a physician), antibiotics (unless medically indicated and prescribed by a physician) or decongestant nose drops / spray (except for isotonic sea water, or if medically indicated and prescribed by a physician) during the study
- •Use of medications or supplements influencing immune function (e.g. antihistamines, systemic corticosteroids, immune-suppressants), and physical performance, as per investigator's judgement, during the study
- •Use of any doping substance as listed by the "World Anti-Doping Agency" at present or in the past, unless prescribed by a physician under a '"therapeutic use exemption", per investigator's judgement
- •Any use of food supplements containing vitamins, minerals, or trace elements, as per investigator's judgement, during the study
- •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)
- •Women of child-bearing potential: pregnant or breastfeeding
- •Participation in other studies within the last month prior to screening and during study
- •Any other clinically significant condition which in the investigator's opinion could interfere with the results of the study or the safety of the subject
研究组 & 干预措施
Placebo
Placebo Comparator
One tablet to be taken daily with any meal, with a glass of water. They should not be chewed, but swallowed whole.
干预措施: Placebo (Dietary Supplement)
IQP-AS-119
Experimental
One tablet to be taken daily with any meal, with a glass of water. They should not be chewed, but swallowed whole.
干预措施: IQP-AS-119 (Dietary Supplement)
结局指标
主要结局
Change in Hooper's Index
时间窗: 5 weeks
Compared between verum and placebo groups at baseline and all timepoints thereafter.
次要结局
- Short Form-12 (SF-12) Health Survey(5 weeks)
- Perceived Stress Questionnaire (PSQ20)(5 weeks)
- URT symptoms recorded in daily dairy(5 weeks)
- Daily subject diary on URT symptoms and other health conditions (including Overall Treatment Effect (OTE)(5 weeks)
- Wisconsin upper respiratory symptom survey (WURSS-21)(5 weeks)
- Global evaluation of benefit (4-point categorical scale)(5 weeks)
- Blood pressure(5 weeks)
- Pulse rate(5 weeks)
- Body temperature(5 weeks)
- Adverse events (AEs) throughout study(5 weeks)
- Global evaluation of tolerability (4-point categorical scale)(5 weeks)
研究者
研究点 (2)
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