ISRCTN14647763已完成未知
Rapid immune-modulating effects: proof of concept study
nigen Inc.0 个研究点目标入组 12 人开始时间: 2022年4月12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
- 12
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37699014/ (added 03/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy adults
- •2. Age 18-75 years (inclusive)
- •3. BMI between 18.0 and 34.9 kg/m² (inclusive)
- •4. Veins easy to see in one or both arms (to allow for the multiple blood draws)
- •5. Willing to comply with study procedures, including:
- •5.1. Maintaining a consistent diet and lifestyle routine throughout the study
- •5.2. Consistent habit of bland breakfasts on days of clinic visits
- •5.3. Abstaining from exercise and nutritional supplements on the morning of a study visit
- •5.4. Abstaining from use of coffee, tea, and soft drinks for at least 1 hour prior to a clinic visit
- •5.5. Abstaining from music, candy, gum, computer/cell phone use, during clinic visits
排除标准
- •1. Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder)
- •2. Taking anti-inflammatory medications on a daily basis
- •3. Currently experiencing intense stressful events/life changes
- •4. Currently in intensive athletic training (such as marathon runners)
- •5. Cancer during the past 12 months
- •6. Chemotherapy during the past 12 months
- •7. Currently treated with immune suppressant medication
- •8. Diagnosed with autoimmune disorders e.g. systemic lupus erythematosus, hemolytic anemia
- •9. Donation of blood during the study or within the 4 weeks prior to study start
- •10. Have received a cortisone shot within the past 12 weeks
- •11. Immunization during last month
- •12. Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication
- •13. Ongoing acute infections (including teeth, sinus, ear, etc)
- •14. Participation in another clinical trial study during this trial, involving an investigational product or lifestyle change
- •15. An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying)
- •16. Unwilling to maintain a constant intake of supplements over the duration of the study
- •17. Anxiety about having blood drawn
- •18. Women of childbearing potential: pregnant, nursing, or trying to become pregnant
- •19. Known food allergies related to ingredients in the active test product or placebo
- •20. Prescription medication will be evaluated on a case-by-case basis
研究者
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