Effects of Resveratrol Supplementation on Inflammatory Biomarkers and Cardiometabolic Parameters in Community-dwelling Adults. (RESINCA-trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Inflammatory biomarkers: Total plasma antioxidant capacity (µmol/L).
研究概览
简要总结
This study aims to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers and cardiometabolic parameters in community-dwelling adults
详细描述
Three groups will be studied: control group (RES 120), experimental group 1 (RES 250) and experimental group 2 (RES 500).
During 8 weeks the RES 120 group will received daily one grape pomace bars with 120 mg of total polyphenols contents (TPC), the RES 250 group will received daily one grape pomace bars enriched with resveratrol until reach 250 mg of TPC and the RES 500 group will received daily one grape pomace bars enriched with resveratrol until reach 500 mg of TPC.
Outcomes will be assessed at baseline and after 8 weeks.
At the end of the study, the groups that shows less o no effects will be invited to enjoy the bar showing to be more effective.
Primary outcomes are: Total plasma antioxidant capacity (TAC), ultra-sensitivity CRP, IL-6, TNF-alfa, plasma malondialdehyde and AGEs.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Comunnity-dwelling persons.
- •Any ethnicity.
- •With willingness to consume the bar daily during the intervention period.
排除标准
- •Allergy/intolerance to ingredients in the bar.
- •Pregnancy or breastfeeding.
- •Use of antioxidant/polymeroid supplements in the last 4 weeks.
- •Unstable chronic diseases (e.g., severe liver failure, advanced kidney failure, active cancer).
- •Persons in treatments that strongly interfere with polyphenol metabolism (e.g., antibiotics, anti-inflammatories, corticosteroids, anti-allergy medication).
- •Persons with metal prosthesis.
- •Persons undergoing or waiting for metabolic bariatric surgery.
- •Persons with scheduled digestive surgery within the next 8 weeks
- •Persons in recent treatments for hypertension (less than 3 month).
- •Participation in another clinical trial.
研究组 & 干预措施
RES 120
This is the control group
干预措施: RES 120 (Dietary Supplement)
RES 250
This is the experimental group 1
干预措施: RES 250 (Dietary Supplement)
RES 500
This is the experimental group 2
干预措施: RES 500 (Dietary Supplement)
结局指标
主要结局
Inflammatory biomarkers: Total plasma antioxidant capacity (µmol/L).
时间窗: From enrollment to the end of treatment at 8 weeks
The total plasma antioxidant capacity by Ferric Reducing Antioxidant Power will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
Inflammatory Biomarkers: Ultra-sensitivity CRP (mg/L).
时间窗: From enrollment to the end of treatment at 8 weeks
The ultra-sensitivity CRP by Elisa test will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
Inflammatory Biomarkers: IL-6 (pg/mL).
时间窗: From enrollment to the end of treatment at 8 weeks
The IL-6 by Elisa test will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
Inflammatory Biomarkers: Plasma malondialdehyde (µmol/L).
时间窗: From enrollment to the end of treatment at 8 weeks
The plasma malondialdehyde by TBARS/HPLC method will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
Inflammatory Biomarkers: TNF-alfa (pg/mL).
时间窗: From enrollment to the end of treatment at 8 weeks
The TNF-alfa by Elisa test will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
Inflammatory Biomarkers: Advanced glycation end-products (AGEs) in 1 to 5 units.
时间窗: From enrollment to the end of treatment at 8 weeks
The AGEs will assess with non-invasive fluorescence pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
次要结局
- Cardiometabolic Parameters: Body weight (kg).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic Parameters: Body mass index-BMI (kg/m2).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic Parameters: Basal metabolic rate (kcal).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic Parameters: Fat mass (kg, %).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic Parameters: Skeletal muscle mass (kg).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic Parameters: Waist-to-hip ratio.(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic Parameters: Handgrip strength (kg).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic Parameters: 30-second sit-to-stand test (n° of repetitions achieved).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic parameters: HRV, RMSSD and SDNN in (ms).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic parameters: PNN50 (%).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic parameters: Insuline (µIU/mL).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic parameters: Glucose (mg/dL).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic parameters: HOMA-IR (index).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic parameters: Lipid profile (mg/dL).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic parameters: Liver profile (U/L).(From enrollment to the end of treatment at 8 weeks)
- Cardiometabolic parameters: Blood pressure (mmHg)(From enrollment to the end of treatment at 8 weeks)