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| Name | Class |
|---|---|
| University of Buenos Aires | OTHER |
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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:
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).
All the instruments used will be used only for you (disposable material), to avoid all types of contagion or infection.
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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wine enriched with Resveratrol | Dietary Supplement | Wine enriched with Resveratrol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Epigenetic age | DNAm Phenoage | 3 months |
| InBody muscle mass | Body composition | 3 months |
| Body composition | InBody fat mass | 3 months |
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Inclusion Criteria:
Exclusion criteria
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Healthy volunteers and with risk factors of cardiovascular diseases
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raul Francisco Pastor | Buenos Aires | Buenos Aires City | 1408 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29676998 | Background | Levine ME, Lu AT, Quach A, Chen BH, Assimes TL, Bandinelli S, Hou L, Baccarelli AA, Stewart JD, Li Y, Whitsel EA, Wilson JG, Reiner AP, Aviv A, Lohman K, Liu Y, Ferrucci L, Horvath S. An epigenetic biomarker of aging for lifespan and healthspan. Aging (Albany NY). 2018 Apr 18;10(4):573-591. doi: 10.18632/aging.101414. | |
| 29206058 |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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Biochemical-Clinical Studies
| Pastor RF, Restani P, Di Lorenzo C, Orgiu F, Teissedre PL, Stockley C, Ruf JC, Quini CI, Garcia Tejedor N, Gargantini R, Aruani C, Prieto S, Murgo M, Videla R, Penissi A, Iermoli RH. Resveratrol, human health and winemaking perspectives. Crit Rev Food Sci Nutr. 2019;59(8):1237-1255. doi: 10.1080/10408398.2017.1400517. Epub 2017 Dec 5. |
| 33076345 | Background | Pastor RF, Repetto MG, Lairion F, Lazarowski A, Merelli A, Manfredi Carabetti Z, Pastor I, Pastor E, Iermoli LV, Bavasso CA, Iermoli RH. Supplementation with Resveratrol, Piperine and Alpha-Tocopherol Decreases Chronic Inflammation in a Cluster of Older Adults with Metabolic Syndrome. Nutrients. 2020 Oct 15;12(10):3149. doi: 10.3390/nu12103149. |
| 33844651 | Background | Fitzgerald KN, Hodges R, Hanes D, Stack E, Cheishvili D, Szyf M, Henkel J, Twedt MW, Giannopoulou D, Herdell J, Logan S, Bradley R. Potential reversal of epigenetic age using a diet and lifestyle intervention: a pilot randomized clinical trial. Aging (Albany NY). 2021 Apr 12;13(7):9419-9432. doi: 10.18632/aging.202913. Epub 2021 Apr 12. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |