Clinical trial NCT05981053: Biological Effects in Consumers of Resveratrol-enriched Wine
Official title: Biological Effects in Consumers of Resveratrol-enriched Wine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Healthy Aging
Sarcopenia
Obesity
Keywords: Food Science & Technology
Epigenetic age
Biological aging
Body composition
Muscle mass
Fat mass
Wine enriched
Resveratrol
Wine and health
Antiaging wine
Lead sponsor: PINER Pastor Manfredi Winery
Sponsor class: INDUSTRY
Collaborators: name: University of Buenos Aires
First posted: 2023-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers and with risk factors of cardiovascular diseases

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age 1.1 Minimum 40 years 1.2 Maximum 80 years
2. Gender 2.1 Male 2.2 Female
3. Habits 3.1 Regular wine consumers

Exclusion criteria

1. Age 1.1 under 40 years 1.2 over 80 years
2. Modifications in treatments during the clinical trial 2.1 Pharmacological 2.2 Non-Pharmacological.
3. Pregnant women.
4. Women in planned pregnancy during the study period.
5. Women in the lactation period.
6. Patients who have been hospitalized for an infectious disease.
7. Patients suffering from autoimmune pathologies.
8. Patients who have cancer.
9. Patients with gastrointestinal pathologies.
10. Patients who have a history of liver disease.
11. Patients who have a history of kidney disease.
12. Patients who have hematological disease.
13. Patients who present disorders of the disease of psychiatric origin.
14. Patients who have epilepsy.
15. Patients with allergies to the active principles of: 15.1 Wine 15.2 Resveratrol.

Primary outcomes:
measure: Epigenetic age
timeFrame: 3 months
measure: InBody muscle mass
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Raul Francisco Pastor
state: Buenos Aires City
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.