Study of the Effect of a Ginger-based Functional Beverage on Markers of Inflammation, Oxidative Stress, and Endothelial Damage.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in serum interleukin-1 beta (IL-1β) levels
研究概览
简要总结
Randomized, double-blind, parallel, placebo-controlled clinical trial designed and conducted to evaluate the effect of daily consumption of ginger, on parameters related to inflammation, oxidative stress, and endothelial damage in adults with excess adiposity.
详细描述
The duration of the study will be 60 days, during which the investigational product or placebo will be consumed daily according to the assigned intervention. Participants will be randomly allocated to the different study arms following a double-blind design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 23 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants.
- •Age between 23 and 65 years.
- •Body mass index (BMI) > 27.5 kg/m².
- •Absence of diagnosed chronic diseases.
- •Not receiving pharmacological treatment or dietary supplementation on a regular basis.
- •Ability to understand the study procedures and willingness to comply with study requirements.
排除标准
- •Presence of acute or chronic diseases not specified in the inclusion criteria.
- •Ongoing chronic pharmacological treatment or active use of dietary supplements.
- •Major surgery within the previous three months.
- •Current smokers or recent former smokers (less than six months since cessation).
- •History of clinically relevant food allergies or eating disorders.
- •Concurrent participation in another clinical trial or research study.
- •Pregnancy or breastfeeding.
- •Following an active weight-loss diet.
- •Investigator's judgment of unsuitability for study participation.
研究组 & 干预措施
Ginger-supplemented beverage
Daily consumption of the functional product enriched with ginger for 60 days.
干预措施: Functional beverage enriched with ginger (Dietary Supplement)
Placebo beverage
Placebo beverage matched in appearance to the intervention for 60 days
干预措施: Control beverage without ginger (Dietary Supplement)
结局指标
主要结局
Change in serum interleukin-1 beta (IL-1β) levels
时间窗: Day 1 and Day 60
Evaluation on differences in serum IL-1β levels
Change in serum interleukin-6 (IL-6) levels
时间窗: Day 1 and Day 60
Evaluation on differences in serum IL-6 levels
Change in plasma homocysteine levels
时间窗: Day 1 and Day 60
Evaluation on differences in homocysteine levels
Change in plasma fibrinogen concentrations
时间窗: Day 1 and Day 60
Evaluation on differences in fibrinogen concentrations
Atherogenic index
时间窗: Day 1 and Day 60
Evaluation on differences in atherogenic index. Differences in the Atherogenic Index of Plasma (AIP), calculated as log (triglycerides/HDL-cholesterol), will be evaluated between the intervention and control groups. Additionally, pre-post changes in AIP will be assessed within each group.
次要结局
- Change in total cholesterol(Day 1 and Day 60)
- Change in LDL-cholesterol(Day 1 and Day 60)
- Change in HDL-cholesterol(Day 1 and Day 60)
- Change in triglycerides(Day 1 and Day 60)
- Change in fasting plasma glucose(Day 1 and Day 60)
- Change in body weight(Day 1 and Day 60)
- Change in body mass index(Day 1 and Day 60)
- Change in fat mass(Day 1 and Day 60)
- Change in lean mass(Day 1 and Day 60)
- Change in blood pressure(Day 1 and Day 60)
研究者
Javier Marhuenda
Principal Investigator
Universidad Católica San Antonio de Murcia