DRKS00010568已完成未知
Double-Blind, Randomized, Placebo-Controlled, Mono-Centre Pilot (Proof-of-Concept) Study to Investigate the Effect of IMPP-1 on Immune Functions That Contribute to Resistance to (Respiratory) Infection in Healthy Subjects
Chief Executive Officer, NutriLeads B.V.0 个研究点目标入组 60 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Apparently healthy, Caucasian, males and females, aged 20–65 years at study start
- •2.BMI of 18.5 to 29.9 kg/m2
- •3.No disorders that may interfere with the study conduct or evaluation, e.g. current or previous respiratory, cardiovascular or metabolic diseases, chronic (auto)-immune, gastrointestinal disorders, infections etc.
- •4.Values within the normal reference range at V1 of leucocytes, lymphocytes and monocytes
- •5.No clinically relevant deviations and/or no deviations > 2 x ULN (upper limit of normal) in other laboratory values at V1
- •6.Readiness to comply with all specific study procedures, in particular:
- •– Consumption of the investigational product (IP) during the entire study
- •– Maintaining the habitual diet, with the exception regarding the required dietary restrictions throughout the study to be complied with
- •– Accepting the collection of fecal samples
- •– Accepting blood draws to evaluate immune response
- •– Filling in health questionnaires
- •7.Women of childbearing potential only:
- •Negative pregnancy testing (ß-HCG (beta subunit of human chorionic gonadotropin) test in urine) at V1 and readiness to use reliable contraception methods for the trial duration
- •Prerequisite for the participation in the study is a written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, possible benefit and possible risks of the clinical study.
排除标准
- •1.Previously known hypersensitivity to any component of the investigational product and/or to the source crop for NutrL-c01
- •2.Known severe acute or chronic immunological disorders such as acquired immune deficiency syndrome (AIDS) (or human immunodeficiency virus (HIV) positive)
- •3.Malignant disease within the last 5 years prior to V1
- •4.Known diagnosed allergies (including any food allergy)
- •5.Untreated or unstable hypertension (>140/90 mmHg)
- •6.Mastopathy and/or menstrual disorders
- •7.Any surgery or vaccination within the last 3 months prior to V1 and during the study
- •8.Intake of antibiotics, systemic corticosteroids, immune-suppressants, psychotherapeutic treatment that may effect the blood count within the last 3 months prior to V1 (except for nonsteroidal anti-inflammatory drugs and other potentially anti-inflammatory local analgesics =2 days prior to V1) and during study and/or intake of any treatment and/or supplementation influencing the immune system during the study (except for nonsteroidal anti-inflammatory drugs and other potentially anti-inflammatory analgesics =2 days prior to V2, V3 and V4)
- •9.Regular use of statins
- •10.Reported, unexplainable weight loss or gain >2 kg in the last month before V1
- •11.Intense sporting activities >10 h/week before V1 and during the study
- •12.Participation in night shift work or reported irregular sleep-wake pattern 2 weeks before V1 and during the study
- •13.Reported dietary restrictions such as consuming a medically prescribed diet, slimming diet or vegetarian diet in the last 3 months prior to V1 or during the study
- •14.Reported total consumption of >10 units (tablets, capsules, sachets etc.) of vitamin supplements containing ß-carotene, vitamin C, E or zinc in the last 3 months prior to V1 or any such supplementation during the study
- •15.Reported consumption of probiotic foods or drinks in the last month prior to V1 or during the study
- •16.Reported alcohol consumption of >2 units/day (1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- •17.Reported history of abuse of drugs or medication in the last 6 months prior to V1
- •18.Regular consumption of tobacco
- •19.Blood donation or transfusion in the last 2 months prior to V1 or during the study
- •20.Participation in another study in the last 2 months before V1 or during the study
- •21.Participation in the present study of a person living in the same household as the subject
- •22.Plans to travel abroad during the period of the entire study
- •23.Inability to comply with study procedures (e.g. due to language difficulties etc.)
- •24.Pregnancy or lactation
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