Dietary Strategy to Tackle Cognitive and Locomotor Abilities in Early Elderly Subjects

NCT06871384 | Recruiting

• 3 other identifiers: WinAging StudyPID2023-148704OB-C22PID2023-148704OB-C21
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief Summary

Polyphenols, precisely resveratrol, with red wine as the most substantial source, was associated with improvements in cognitive function. Also, the loss of muscle mass and strength in elderly, that significantly increases dependency of these people, it could be attributed to alterations in gut microbiota through the "gut-muscle axis" and this underline the urgent need to efficiently find out any intervention or preventive approach via modulation of gut microbiota to improve muscle function in elderly. In this context, red wine polyphenols exert their effects through interaction with gut microbiota following the well-known two-way interaction between polyphenols and gut microbiota by promoting the proliferation of beneficial bacteria and increasing their abundance. Similarly, aging cognitive decline can be modulate by microbiota, notably through "gut-brain axis". Additionally, dietary polyphenols can delay inflammation or/and oxidation on the onset of age-related cognitive decline or muscular oxidation or cardiovascular factors risk factors, all of them relevant factors for the onset of physical frailty and dependence in elderly. Moreover, wine is a singular alcoholic beverage with a high content of phenolic compounds of a very diverse nature on which numerous protective effects on health have been described. In fact, wine, in addition to alcohol, contains a complex mixture of polyphenols, including anthocyanins and non-coloured phenols as proanthocyanidins, flavonols, hydroxycinnamic and hydroxybenzoic acids, stilbenes and lignans. Thus, the bioprotective effects of wine polyphenols could be the consequence of the synergistic effect of this complex mixture of polyphenols from the grape and the winemaking process. That is why it is essential to clarify whether consumption of polyphenols from red wine provided by a nonalcohol red wine within a healthy diet can produce beneficial effects on health, differentiating this pattern from a general consumption of alcohol generally associated with negative effects. Based on the ethical limitations to carry out diet intervention studies with wine in humans, this project proposes the use of a nonalcoholic wine as vehicle of the complex mixture of red wine polyphenols. The hypothesis of our research is that regular consumption of red wine polyphenols, 150 mg/day, delivered through a nonalcoholic red wine, in the context of a Mediterranean diet (MD pattern), could promote protective mechanisms for a healthy aging, especially through its beneficial effects on cognitive and locomotor abilities and mediated by the modulation of the intestinal microbiota (composition, function and associated metabolome). The main objective of the WinAging project is to add knowledge concerning the diet modulation of molecular mechanisms of the aging process through multi-omic approaches based on the potential health effects of a dietary strategy by a sustained MD supplementation with nonalcoholic red wine rich in polyphenols to tackle cognitive and locomotor abilities in early elderly home-dwelling subjects. The specific objectives:

• Objective 1. To develop a nonalcoholic red wine with high phenolic content and sensorial acceptability.
• Objective 2. To evaluate the chronic effects of the intake of wine polyphenols (average dose 150 mg/day) delivered through a nonalcoholic red wine in the context of a MD in early elderly home-dwelling subjects, and applying participatory research to increase adherence of subjects in the clinical intervention study.
• Objective 2.1. To identify selective biological phenolic metabolites in human urine samples to be used as biomarkers of nonalcoholic red wine intake.
• Objective 2.2. To assess the effects of the diet supplementation with red wine polyphenols on the improvement of cognitive ability.
• Objective 2.3. To assess the effects of the diet supplementation with red wine polyphenols on the improvement of locomotor ability
• Objective 2.4. To evaluate the effect of the diet supplementation with red wine polyphenols on the improvement of cardiovascular disease (CVD) risk factors.
• Objective 3. To unravel the underlying mechanisms involved in the potential beneficial effects of red wine polyphenols on aging.
• Objective 3.1. To evaluate the influence on microbiota composition, function and microbial catabolites.
• Objective 3.2. To evaluate the impact on inflammation and gut health.
• Objective 3.3. To evaluate the impact on metabolic pathways related with aging
• Objective 3.4. To analyze the impact on age-related epigenetic modifications
• Objective 3.5. To deeply characterize the underlying muscle signalling pathways affected using an animal model of aging.
• Objective 4. To apply integrative computational analyses for the identification of variables (clinical or gut-related) more determinant for a successful prevention of locomotor and cognitive abilities associated with wine polyphenols.

Conditions

Cognitive Disorders; Muscular Disorders, Atrophic

Keywords

cognitive impairment; locomotor impairment; sarcopenia; aging; mediterrnean diet; non-alcoholic wine; polyphenols

Outcome Measures

Primary Outcomes (2)

• Cognitive function

  The MMSE test for cognitive function. The total test score ranges from 0 (impaired) to 30 (normal) (Beaman et al., 2004).

  Visit 0 (week -1), visit 1 (week 0), visit 4 (week 12), visit 7 (week 24), visit 10 (week 36)

• Muscle strength

  The muscle strength based on handgrip dynamometry (Jamar dynamometer; Sammons Preston Rolyan, Bolingbrook, IL)

  Visit 1 (week 0), visit 4 (week 12), visit 7 (week 24), visit 10 (week 36)

Secondary Outcomes (76)

• Anthropometric measures

  Visit 0 (week -1), visit 1 (week 0), visit 4 (week 12), visit 7 (week 24), visit 10 (week 36)

• Anthropometric measures

  Visit 0 (week -1), visit 1 (week 0), visit 4 (week 12), visit 7 (week 24), visit 10 (week 36)

• Anthropometric measures

  Visit 0 (week -1), visit 1 (week 0), visit 4 (week 12), visit 7 (week 24), visit 10 (week 36)

• Anthropometric measures

  Visit 0 (week -1), visit 1 (week 0), visit 4 (week 12), visit 7 (week 24), visit 10 (week 36)

• Anthropometric measures

  Visit 0 (week -1), visit 1 (week 0), visit 4 (week 12), visit 7 (week 24), visit 10 (week 36)

Study Arms (2)

Nonalcoholic red wine group (Intervention group)

EXPERIMENTAL

Mediteranean diet + nonalcoholic red wine

Dietary Supplement: Nonalcoholic red wine group (Intervention group)

Drinking water group (Control group)

PLACEBO COMPARATOR

Mediterranean diet + drinking water

Dietary Supplement: Drinking water group (Control group)

Interventions

Nonalcoholic red wine group (Intervention group) DIETARY_SUPPLEMENT

Mediteranean diet + nonalcoholic red wine (300 mL wine/day, equivalent to a daily dose of 150 mg red wine polyphenols/day, during meals)

Nonalcoholic red wine group (Intervention group)

Drinking water group (Control group) DIETARY_SUPPLEMENT

Mediterranean diet + drinking water (300 mL/day, during meals)

Drinking water group (Control group)

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Men or women \>75 years old,
• Hypoglucaemiant treatment or type 1 and type 2 diabetes mellitus diagnosed
• Anaemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
• Subjects diagnosed of intestinal disorders such as chron disease, colitis ulcerous, and irritable bowel syndrome
• To present a clinical active chronic disease
• To present severe sarcopenia
• To present cognitive impairment (MMSE ≤ 24 or clinical diagnosis of mild cognitive impairment or dementia)
• Dietary allergies to: Mediterranean foods (eg, nuts), sulphytes or nitrates
• Use of antioxidants supplements
• Regular consumers of red wine who do not agree to change the consumption of red wine with alcohol to nonalcholized wine during the intervention
• Chronic alcoholism

Sponsors & Collaborators

• University Rovira i Virgili: lead
• National Research Council, Spain: collaborator

Study Sites (3)

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

Universitat Rovira i Virgili, Facultat de Medicina i Ciències de la Salut, Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut)

Reus, Spain, 43201, Spain

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Muscular Disorders, Atrophic; Sarcopenia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Anna Pedret Figuerola, Dr.

  Universitat Rovira i Virgili, Facultat de Medicina i Ciències de la Salut, NFOC-Salut group, 43201 Reus, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosa Solà Alberich, Professor

CONTACT

+34 977 759 369; rosa.sola@urv.cat

Anna Pedret Figuerola, Dr.

CONTACT

+34 977 759 375; anna.pedret@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Dr. Rosa Solà Alberich

Model Details: Randomized, controlled parallel intervention study. The total duration of the intervention will be 9 months. Subjects will be assigned to participate in any of the two groups in a randomized fashion: 1. Intervention group: Mediteranean diet + nonalcoholic red wine (300 mL wine/day, equivalent to a daily dose of 150 mg red wine polyphenols/day, during meals) 2. Control group (Group B): Mediterranean diet + drinking water (300 mL/day, during meals).

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 11, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)