Development of a Novel Polyphenol-Enriched Functional Product for the Treatment of Overweight and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
The aim of this randomized, parallel, two-arm, placebo-controlled, quadruple-blind clinical trial is to evaluate the efficacy of a polyphenol-enriched functional product in individuals with overweight or obesity, focusing primarily on body composition, insulin sensitivity, inflammatory markers, and other metabolic health parameters.
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 assignment.
Subjects will be randomized to each of the study arms (consumption of the polyphenol-enriched product or control product).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes, aged 18 years or older.
- •Body Mass Index (BMI) between 25 and
- •Clinical diagnosis of overweight or obesity according to established criteria.
- •Ability to understand and sign the informed consent form.
排除标准
- •Presence of severe or terminal chronic diseases.
- •Current treatment with antioxidants or similar dietary supplements.
- •Known allergies to any of the product components.
- •Pregnancy or breastfeeding.
- •Participation in another clinical trial within the past 3 months.
研究组 & 干预措施
Experimental
Daily consumption of the polyphenol-enriched functional product for 60 days.
干预措施: Polyphenol-enriched functional product (Dietary Supplement)
Control
Identically appearing placebo capsules consumed for 60 days.
干预措施: Control without active polyphenols (Dietary Supplement)
结局指标
主要结局
Change in Body Weight
时间窗: Day 1 and Day 60
Evaluation of differences in body weight (kg)
Change in fat mass
时间窗: Day 1 and Day 60
Evaluation of differences in fat mass (kg)
Change in fat mass (%)
时间窗: Day 1 and Day 60
Evaluation of differences in fat mass percentage (%)
Change in Body Mass Index (BMI)
时间窗: Day 1 and Day 60
BMI will be calculated from measured weight and height using the formula weight (kg) / height² (m²).
次要结局
- Change in plasma adiponectin levels(Day 1 and Day 60)
- Change in plasma SOCS3 levels(Day 1 and Day 60)
- Change in fasting glucose(Day 1 and Day 60.)
- Change in fasting insulin(Day 1 and Day 60.)
- Change in plasma leptin levels(Day 1 and Day 60)
- Change in plasma ghrelin levels(Day 1 and Day 60)
- Change in plasma interleukin-1 (IL-1β) levels(Day 1 and Day 60)
- Change in plasma interleukin-6 (IL-6) levels(Day 1 and Day 60)
- Change in plasma interleukin-10 (IL-10) levels(Day 1 and Day 60)
- Change in plasma oxidized LDL (oxLDL) levels(Day 1 and Day 60)
- Change in plasma malondialdehyde (MDA) levels(Day 1 and Day 60)
- Change in plasma superoxide dismutase (SOD) levels(Day 1 and Day 60)
- Changes in C-reactive protein (CRP)(Day 1 and Day 60)
研究者
Carmen Lucas Abellán
Principal Investigator
Universidad Católica San Antonio de Murcia