Biological Effects in Consumers of Resveratrol-enriched Wine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Epigenetic age
研究概览
简要总结
The objective of this clinical trial is to compare the health conditions of the participating population before and after an intervention with Resveratrol enriched wine.
The main questions it aims to answer are:
- • The consumption of wine enriched with resveratrol could slow down or reverse the biological age ?
- • The consumption of wine enriched with resveratrol could improve body composition fat mass / muscle mass ? The participants will be evaluated at the beginning and at the end of the clinical trial and will adopt only one change in their habits, that is, change the usual wine they consume with their meals for a wine enriched with resveratrol, in a moderate measure, 250 cc for men and 125 cc/day for women. The design of the study will be that each volunteer is their own control, pre and post intervention.
详细描述
Study objectives The objective of the study is to determine the possible relationship between the consumption of pure Malbec wine 100% enriched with pure resveratrol (150 mg/L of wine) ingested during meals, with biomarkers (oxidative stress, DNA damage, antioxidant defenses and chronic systemic inflammation in blood and urine), generated in the body by the damage produced by the oxidative stress of metabolism, age and chronic pathologies.
Procedures to follow
- First visit A doctor will take details of your medical history, perform a complete physical examination, and explain the reasons for the study. If you meet the criteria and are eligible to be included in the study, you will only be told not to take dietary supplements or antioxidants and you will be seen again in the office two weeks later. At that time, you will be asked to carry out a blood laboratory analysis. These will be the Baseline Controls.
- Visits 30, 60, 90 days:
Each period between consultations is 30 days, during which time the participant follows a free diet. At the end of each month, you will go for a medical consultation and be given the resveratrol-enriched wine. In the 4th consultation (90 days) the procedure of the first consultation will be repeated. That is, Consultation + Fasting blood extraction.
Observations of eventual adverse events will be recorded; the information will be recorded in the CRF (Clinical Research Form).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 1.1 Minimum 40 years 1.2 Maximum 80 years
- •Gender 2.1 Male 2.2 Female
- •Habits 3.1 Regular wine consumers
- •Exclusion criteria
- •Age 1.1 under 40 years 1.2 over 80 years
- •Modifications in treatments during the clinical trial 2.1 Pharmacological 2.2 Non-Pharmacological.
- •Pregnant women.
- •Women in planned pregnancy during the study period.
- •Women in the lactation period.
- •Patients who have been hospitalized for an infectious disease.
- •Patients suffering from autoimmune pathologies.
- •Patients who have cancer.
- •Patients with gastrointestinal pathologies.
- •Patients who have a history of liver disease.
- •Patients who have a history of kidney disease.
- •Patients who have hematological disease.
- •Patients who present disorders of the disease of psychiatric origin.
- •Patients who have epilepsy.
- •Patients with allergies to the active principles of: 15.1 Wine 15.2 Resveratrol.
排除标准
- 未提供
结局指标
主要结局
Epigenetic age
时间窗: 3 months
DNAm Phenoage
InBody muscle mass
时间窗: 3 months
Body composition
Body composition
时间窗: 3 months
InBody fat mass
次要结局
未报告次要终点