Biological Effects in Consumers of Resveratrol-enriched Wine
Condition: Aging; Healthy Aging; Sarcopenia; Obesity
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      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:

        1. • The consumption of wine enriched with resveratrol could slow down or reverse the
           biological age ?

        2. • 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.
    

Detailed description: 
      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

        1. 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.

        2. 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).

           All the instruments used will be used only for you (disposable material), to avoid all
           types of contagion or infection.

        3. Biochemical Analysis Determination of analysis to perform on the samples obtained from
           venous blood, initial and final at 90 days.

           samples. Venous blood will be obtained with heparin at both moments according to the
           protocol, with a 12-h fast. Start and end at 90 days.

           Determinations. Analysis of oxidative damage, analysis of enzymatic antioxidant
           defenses, inflammatory response in polymorphonuclear cells (PMN), red blood cells,
           plasma, and general biochemical analysis will be performed.

           Biochemical-Clinical Studies

             1. Ferritin

             2. Complete blood count w/Platelet count

             3. Mean cell volume

             4. RDW - Red Distribution Width

             5. Ultrasensitive PCR

             6. Glycemia

             7. Creatinine

             8. albumin

             9. Alkaline Phosphatase

        4. Body composition analysis The determination of the InBody analysis will be carried out
           at the beginning and at the end of the study.

      Statistical analysis: The statistical analysis was performed using the Student t-test for
      paired samples (Prism 7.0, GraphPad, San Diego, CA, USA). The Student t-test was selected to
      evaluate a single biomarker at a time in eight series of paired data (D0 vs. D90 for
      chronological and DNAm PhenoAge, muscle mass and fat mass) for each patient before and after
      the intervention. Results with p < 0.05 were considered significant.
    

Intervention name(s): Wine enriched with Resveratrol
Intervention type(s): Dietary Supplement
Intervention description(s): Wine enriched with Resveratrol
Other intervention name(s): https://vinospiner.com.ar/
Intervention MeSH terms: Resveratrol
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers and with risk factors of cardiovascular diseases
      
Biospecimen description: 
      Biochemical-Clinical Studies

        1. Ferritin

        2. Complete blood count w/Platelet count

        3. Mean cell volume

        4. RDW - Red Distribution Width

        5. ultrasensitive PCR

        6. Glycemia

        7. Creatinine

        8. albumin

        9. Alkaline Phosphatase
    
Keywords: Food Science & Technology; Epigenetic age; Biological aging; Body composition; Muscle mass; Fat mass; Wine enriched; Resveratrol; Wine and health; Antiaging wine