Daily nonalcoholic red-wine polyphenol drink to support thinking and mobility in early elderly adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, two-arm trial will randomize 72 community-dwelling volunteers aged 60–74 to either a nonalcoholic red-wine beverage or drinking water for nine months, with 36 participants per arm. Participants will attend 11 scheduled visits including baseline, periodic telephone check-ins, and fasting blood draws at key visits; objective measures include NMR body composition, optional muscle biopsy, and isokinetic muscle testing alongside questionnaires for activity, mood, and quality of life. The intervention targets modulation of the gut microbiota and antioxidant/anti-inflammatory effects of polyphenols to influence the gut–muscle and gut–brain axes. Outcomes will compare changes in cognitive and locomotor measures between the two groups over the intervention period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\. Men or women between 60-74 years old; Sensory tolerance to red wine; Written informed consent provided before the initial screening visit.

Exclusion Criteria:

1. Men or women \>75 years old,
2. Hypoglucaemiant treatment or type 1 and type 2 diabetes mellitus diagnosed
3. Anaemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
4. Subjects diagnosed of intestinal disorders such as chron disease, colitis ulcerous, and irritable bowel syndrome
5. To present a clinical active chronic disease
6. To present severe sarcopenia
7. To present cognitive impairment (MMSE ≤ 24 or clinical diagnosis of mild cognitive impairment or dementia)
8. Dietary allergies to: Mediterranean foods (eg, nuts), sulphytes or nitrates
9. Use of antioxidants supplements
10. Regular consumers of red wine who do not agree to change the consumption of red wine with alcohol to nonalcholized wine during the intervention
11. Chronic alcoholism
12. Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study
13. Failure to follow the study guidelines. For participation in the muscle biopsy, additional exclusion criteria included: Use of prescription anti-platelet medication; Prescription anticoagulant use (or antiaggregant, or acenocoumarol; Conditions which would reduce healing; or known allergy to lidocaine.

Where it's running

• Universitat Rovira i Virgili, Facultat de Medicina i Ciències de la Salut, Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut)
  Reus, Spain, Spain Recruiting
• Instituto de Ciencias de la Vid y del Vino-ICVV (Consejo Superior de Investigaciones Científicas-CSIC, Universidad de La Rioja, Gobierno de La Rioja)
  Logroño, Spain, Spain Active not recruiting
• Lyfestyle, Microbiota and Health Unit, Health Sciences Faculty, University of La Rioja
  Logroño, Spain, Spain Active not recruiting

Study contacts

• Principal investigator: Rosa Solà Alberich, Professor — Universitat Rovira i Virgili, Facultat de Medicina i Ciències de la Salut, NFOC-Salut group, 43201 Reus, Spain Institut Investigació Sanitària Pere i Virgili (ISPV), 43204, Reus, Spain Hospital Universitari Sant Joan de Reus, 43204, Reus, Spain
• Study coordinator: Rosa Solà Alberich, Professor
• Email: rosa.sola@urv.cat
• Phone: +34 977 759 369

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.