ISRCTN11550896已完成未知
Double-blind, randomized, placebo-controlled assessment of the antioxidant efficacy of an ingredient to be used in food supplements (ROC H clinical trial 2020)” aimed to assess the efficacy of Red Orange Complex H
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- BIONAP srl
- 入组人数
- 60
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36296919/ (added 07/11/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men (50%) and women (50%) aged 45-60 years old
- •2. Subjects with menopausal symptoms (only for women)
- •3. Subjects naïve to treatment and food supplements that can interfere with the study treatment for the previous 1 month
- •4. Not used topical products/food supplements with similar effects to the product being tested (antioxidant) during the entire study period
- •5. Subjects registered with health social security or health social insurance
- •6. Subjects reading, understanding and signed approval of the informative consent
- •7. Not vegetarian
- •8. Subjects who will continue their normal lifestyle
- •9. Healthy subjects without clinical illness diagnosed with relevant diseases of the gastrointestinal system or visceral motility
- •10. Not pregnant
- •11. Non-smokers
- •12. Subjects available and willing to follow the procedures of the study protocol
- •13. Subjects able to understand the language used in the investigation centre and the information given
排除标准
- •1. Subjects who do not fit the inclusion criteria
- •2. Subjects <45 and >60 years old
- •3. Clinical history of relevant present disorders or administration of drugs/food supplements that can potentially interfere with the treatment under study
- •4. Lack of compliance defined as not using the correct dose or placebo for >1 week, and the inability to give informed consent
- •5. Subjects who have changed their diet significantly or have been placed on weight reduction products
- •6. Smokers, obese subjects
- •7. Subjects changing their eating habits within the 2 weeks previous to the screening
- •8. Pregnancy or subjects planning a pregnancy
- •9. Breastfeeding
- •10. Subjects with a history of drug, alcohol, and other substance abuse
- •11. Subjects planning to change their lifestyle or physical activity
- •12. Known food intolerance or food allergy
- •13. Subjects involved in a clinical or food study within the previous month
- •14. Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure)
- •15. Subjects with a history of paralysis or cerebral vascular accident
- •16. Subjects with active cancers or on chemotherapy
- •17. Subjects who have been under diuretics for the previous one months
- •18. Other factors that limit their ability to cooperate during the study
- •19. Subjects deprived of freedom by administrative or legal decision or under guardianship
- •20. Subjects not able to be contacted in case of emergency
- •21. Subjects planning a hospitalisation during the study
研究者
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