Assessment of Opuntia Ficus-indica Supplementation on Improving Antioxidant and Inflammation Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Inflammation Levels
研究概览
简要总结
The goal of this clinical trial is to learn if supplementation Opuntia ficus-indica improve the antioxidant status and inflammation levels of the participants. The main questions it aims to answer are:
- Does supplementation Opuntia ficus-indica improve the antioxidant status of the participants?
- Does supplementation Opuntia ficus-indica improve the inflammation levels of the participants?
Researchers will compare before and after intervention to see if supplementation Opuntia ficus-indica works to improve the antioxidant status and inflammation levels of the participants.
Participants will:
Take drug supplementation Opuntia ficus-indica every day for 12 weeks. Visit the clinic once every 4 weeks for checkups and tests
详细描述
Study Design
This open-label, single-arm, prospective study involved a supplementation period of three months. The research was conducted in full compliance with the Declaration of Helsinki and the criteria outlined in Malaysian guidelines for Good Clinical Practice [76]. Participant eligibility was confirmed according to the protocol checklist, and written informed consent was obtained from all participants. The study received approval from the Institutional Ethics Committee, UCSI University, Malaysia, approval code is IEC-2022-FMHS-082.
Participants Selection
Participants were recruited through off-campus advertisements, and the study was conducted at UCSI University in Kuala Lumpur, Malaysia. The inclusion criteria were as follows: (1) generally healthy individually; (2) aged 18 years and above; (3) capable of understanding the study protocol and information; and (4) willing to provide informed consent. Exclusion criteria included: (1) currently undergoing supplementation aimed at enhancing antioxidant status, (2) having undergone major surgical procedures within six months before study entry and (3) pregnant or lactating woman. All participants were provided a participant information sheet and received a thorough explanation from the investigator. Written informed consent was obtained from each participant. Potential risks, including food allergies, were communicated to participants during the consent process.
Supplementation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy individually
- •aged 18 years and above
- •capable of understanding the study protocol and information
- •willing to provide informed consent.
排除标准
- •currently undergoing supplementation aimed at enhancing antioxidant status
- •having undergone major surgical procedures within six months before study entry
- •pregnant or lactating woman.
结局指标
主要结局
Inflammation Levels
时间窗: From enrollment to the end of intervention at 12 weeks
Unstimulated saliva samples were collected using a sterile 2.0-mL vial. Participants uncapped the vial, placed the straw into the vial, and passively drooled down the straw for 90 secs. All samples were assayed for different parameters in duplicates. Inflammatory markers IL-1beta, IL-6 and IL-10 were assayed using Elabsciecne ELISA Kit (Elabscience Biotechnology Co. Ltd, Texas, United States).
Antioxidant Status
时间窗: From enrollment to the end of intervention at 12 weeks
Unstimulated saliva samples were collected using a sterile 2.0-mL vial. Participants uncapped the vial, placed the straw into the vial, and passively drooled down the straw for 90 secs. All samples were assayed for different parameters in duplicates. Total antioxidant capacity was assayed using Elabsciecne total T-AOC colourimetric assay kit (Elabscience Biotechnology Co. Ltd, Texas, United States), MDA as lipid peroxidation biomarker was assayed using Elabsciecne MDA colourimetric assay Kit (Elabscience Biotechnology Co. Ltd, Texas, United States), 3-NT as a biomarker of oxidative stress-derived protein damage was assayed using Elabsciecne 3-NT ELISA Kit (Elabscience Biotechnology Co. Ltd, Texas, United States) and 8-OHdG as a biomarker of oxidative stress-derived DNA damage was assayed using Elabsciecne 8-OHdG ELISA Kit (Elabscience Biotechnology Co. Ltd, Texas, United States).
次要结局
- Vital Signs - Blood Pressure(From enrollment to the end of intervention at 12 weeks)
- Vital Signs - Heart Rate(From enrollment to the end of intervention at 12 weeks)
- Vital Signs - Body Temperature(From enrollment to the end of intervention at 12 weeks)
- General Wellbeing(From enrollment to the end of intervention at 12 weeks)