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AgingNCT05981053

Biological Effects in Consumers of Resveratrol-enriched Wine

An observational study of Aging and Healthy Aging, run by PINER Pastor Manfredi Winery at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Healthy Aging, Sarcopenia
What is being tested?
Wine enriched with Resveratrol
How many people
30 participants
Where
1 siteArgentina
Study dates
15 Jul 2022to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy volunteers and with risk factors of cardiovascular diseases

Who may be able to join

  • Age 1.1 Minimum 40 years 1.2 Maximum 80 years
  • Gender 2.1 Male 2.2 Female
  • Habits 3.1 Regular wine consumers

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Raul Francisco Pastor

    Buenos Aires, Buenos Aires City, 1408

Other trials in Argentina

About this study

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.
Read the 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
  4. Ferritin
  5. Complete blood count w/Platelet count
  6. Mean cell volume
  7. RDW - Red Distribution Width
  8. Ultrasensitive PCR
  9. Glycemia
  10. Creatinine
  11. albumin
  12. Alkaline Phosphatase
  13. 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.

Being tested
Wine enriched with Resveratrol
Keywords
Food Science & Technology, Epigenetic age, Biological aging, Body composition, Muscle mass, Fat mass, Wine enriched, Resveratrol, Wine and health, Antiaging wine
Medical subject headings
Sarcopenia, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wine enriched with ResveratrolDietary supplement

    Also called https://vinospiner.com.ar/

    Wine enriched with Resveratrol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Epigenetic age

    DNAm Phenoage

    Measured: 3 months

  2. InBody muscle mass

    Body composition

    Measured: 3 months

  3. Body composition

    InBody fat mass

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start15 Jul 2022
  3. Primary completion28 Apr 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05981053
Sponsor's protocol ID
#26122021
Status last verified
Aug 2023
First submitted
31 Jul 2023
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29676998

  • 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.

    PubMed 29206058

  • 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.

    PubMed 33076345

  • 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.

    PubMed 33844651

Questions about this trial

What is this clinical trial studying?

An observational study of Aging and Healthy Aging, run by PINER Pastor Manfredi Winery at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epigenetic age (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05981053, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

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