AzTrials
AzTrials

Cognitive DisordersWinAgingNCT06871384

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

A study testing Nonalcoholic red wine group (Intervention group) in people with Cognitive Disorders and Muscular Disorders, Atrophic, run by University Rovira i Virgili at 3 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 74 yearsHealthy volunteers can take part
What is being tested?
Nonalcoholic red wine group (Intervention group)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
3 sitesSpain
Study dates
26 Mar 2025to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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
  • Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

Spain3 sites, 1 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

    Active, not recruiting

  • Lyfestyle, Microbiota and Health Unit, Health Sciences Faculty, University of La Rioja

    Logroño, 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

    Rosa Solà Alberich, Professor, +34 977 759 369, rosa.sola@urv.cat

    Anna Pedret Figuerola, Dr., +34 977 759 375, anna.pedret@urv.cat

    Recruiting

Other trials in Spain

About this study

Official title: Polyphenols From Nonalcoholic Red Wine and Healthy Aging: an Opportunity to Understand Diet Modulation of the Aging Process From a Multidimensional Perspective

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.

Read more

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.
Read the detailed description

A total of 72 home-dwelling early elderly volunteers (men and women) 60-74 years old will be included in the intervention (36 in each arm of the intervention).

During the study there will be 11 visits in total. Visits will be every 4 weeks form the V1. The study visits will be the following:

  • Screening visit (V0).
  • Basal visit (V1).
  • Visits during intervention (V2, V3, V4, V5, V6, V7, V8, V9).
  • 3-month study visit (V4)
  • 6-month study visit (V7)
  • Telephone visits (V2, V3, V5, V6, V8, V9)
  • Final study visit (V10). In visits V0, V1, V4, V7 and V10 volunteers must present themselves in fasting conditions of 8 hours to obtain fasting blood samples.
  • In addition, future candidates will be provided with the nonalcoholic wine, selected for study and allowed to taste it for one week to check its tolerability and sensory acceptance and thus ensure that candidates can commit to drinking the study wine daily for 9 months and reduce follow-up losses during the intervention.

Basal visit (V1; week 0):

  • Nuclear Magnetic Resonance (NMR) and muscle biopsy (±5 days V1)*.
  • Isokinetic assessment (±5 days V1)*
  • Revision of study clinical history.
  • Vital signs (blood pressure/resting heart rate).
  • Checking the concomitant medication.
  • Anthropometry waist circumference; hip; body weight and composition; height).
  • Checking the physical activity and sedentary habits (IPAQ-E).
  • Checking the quality of life (SF-36 Health survey questionnaire)
  • Checking depression symptoms (Geriatric Depression Scale Questionnaire)
  • Checking MD adherence
  • Checking the cognitive and locomotor abilities
  • Spanish validated of the Mini Mental State Examination (MMSE), Alzheimer disease questionnaire (AD8), Memorey Alteration tets (TAM test), Fototest
  • Sarcopenic parameters (muscle strength based on grip dynamometry; skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 and appendicular skeletal muscle mass index (ASMI) based on bioimpedance analysis (BIA), low physical performance or physical function based on 4 m gait speed, m/s.
  • Blood sample extraction.
  • Ultrasound (muscle mass and abdominal fat).
  • Checking the 3-day dietary record and Food Frequency Questionnaire (FFQ).
  • Collection of feaces samples.
  • Collection of saliva samples.
  • Collection of urine samples.
  • MD guidelines explanation.
  • Schedule the next visit and instructions.
  • Administration of red nonalcoholic wine through opaque bottles to protect from light.
  • In a subsample of n= 15 subjects/group, 5 days before or after the visit V1, volunteers must have a:
  • NMR, in order to measure changes in hippocampal volume, and volume of white matter hyperintense lesions,
  • Muscle biopsys, in order to measure changes in signalling pathways in skeletal muscle,
  • Isokinetics analysis in order to measure changes in muscle function through variables such as torque, work and power.

Telephone visits: (V2 and V3; week 4 and 8):

  • Checking the FFQ
  • Checking changes in concomitant medication
  • Product intake control
  • Record adverse effects
  • Schedule the next visit and instructions. 3-month study visit (V4; week 12):
  • Revision of study clinical history.
  • Vital signs (blood pressure/resting heart rate).
  • Checking the concomitant medication.
  • Anthropometry waist circumference; hip; body weight and composition; height).
  • Checking the physical activity and sedentary habits (IPAQ-E).
  • Checking the quality of life (SF-36 Health survey questionnaire)
  • Checking depression symptoms (Geriatric Depression Scale Questionnaire)
  • Checking MD adherence
  • Checking the cognitive and locomotor abilities
  • Spanish validated of the MMSE, AD8, TAM test, Fototest
  • Sarcopenic parameters (muscle strength based on grip dynamometry; skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 and appendicular skeletal muscle mass index (ASMI) based on bioimpedance analysis (BIA), kg/m2; low physical performance or physical function based on 4 m gait speed, m/s.
  • Blood sample extraction.
  • Ultrasound (quadricep muscle mass and abdominal fat).
  • Checking the Food Frequency Questionnaire, Mediterranean adherence (FFQ).
  • Collection of urine samples.
  • Product intake control
  • Record adverse effects
  • MD guidelines explanation.
  • Schedule the next visit and instructions.
  • Administration of red nonalcoholic wine through opaque bottles to protect from light.

Telephone visits: (V5 and V6; week 16 and 20):

  • Checking the FFQ
  • Checking changes in concomitant medication
  • Product intake control
  • Record adverse effects
  • Schedule the next visit and instructions. 6-month study visit (V7; week 24):
  • Revision of study clinical history.
  • Vital signs (blood pressure/resting heart rate).
  • Checking the concomitant medication.
  • Anthropometry waist circumference; hip; body weight and composition; height).
  • Checking the physical activity and sedentary habits (IPAQ-E).
  • Checking the quality of life (SF-36 Health survey questionnaire)
  • Checking depression symptoms (Geriatric Depression Scale Questionnaire)
  • Checking MD adherence
  • Checking the cognitive and locomotor abilities
  • Spanish validated of the MMSE, AD8, TAM test, Fototest
  • Sarcopenic parameters (muscle strength based on grip dynamometry; skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 and appendicular skeletal muscle mass index (ASMI) based on bioimpedance analysis (BIA), kg/m2; low physical performance or physical function based on 4 m gait speed, m/s.
  • Blood sample extraction.
  • Ultrasound (quadricep muscle mass and abdominal fat).
  • Checking the 3-day dietary record and Food Frequency Questionnaire (FFQ).
  • Collection of feaces samples.
  • Collection of saliva samples.
  • Collection of urine samples.
  • MD guidelines explanation.
  • Schedule the next visit and instructions.
  • Administration of red nonalcoholic wine through opaque bottles to protect from light.

Telephone visits: (V8 and V9; week 28, and 32):

  • Checking the FFQ
  • Checking changes in concomitant medication
  • Product intake control
  • Record adverse effects
  • Schedule the next visit and instructions.

Final visit (V10; week 36):

  • NMR and muscle biopsy (±5 days V1)*.
  • Isokinetic assessment (±5 days V1)*
  • Revision of study clinical history.
  • Vital signs (blood pressure/resting heart rate).
  • Checking the concomitant medication.
  • Anthropometry waist circumference; hip; body weight and composition; height).
  • Checking the physical activity and sedentary habits (IPAQ-E).
  • Checking the quality of life (SF-36 Health survey questionnaire)
  • Checking depression symptoms (Geriatric Depression Scale Questionnaire)
  • Checking MD adherence
  • Checking the cognitive and locomotor abilities
  • Spanish validated of the MMSE, AD8, TAM test, Fototest
  • Sarcopenic parameters (muscle strength based on grip dynamometry; skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 and appendicular skeletal muscle mass index (ASMI) based on bioimpedance analysis (BIA), kg/m2; low physical performance or physical function based on 4 m gait speed, m/s.
  • Blood sample extraction.
  • Ultrasound (quadricep muscle mass and abdominal fat).
  • Checking the 3-day dietary record and Food Frequency Questionnaire (FFQ).
  • Collection of feaces samples.
  • Collection of saliva samples.
  • Collection of urine samples. *In a subsample of n= 15 subjects/group, 5 days before or after the visit V10.
  • Nuclear Magnetic Resonance (NMR), in order to measure changes in hippocampal volume, and volume of white matter hyperintense lesions,
  • Muscle biopsys, in order to measure changes in signalling pathways in skeletal muscle,
  • Isokinetics analysis in order to measure changes in muscle function through variables such as torque, work and power.
Being tested
Nonalcoholic red wine group (Intervention group), Drinking water group (Control group)
Keywords
cognitive impairment, locomotor impairment, sarcopenia, aging, mediterrnean diet, non-alcoholic wine, polyphenols
Medical subject headings
Cognitive Dysfunction, Muscular Disorders, Atrophic, Sarcopenia

What participants receive

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

  • 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)

  • Drinking water group (Control group)Dietary supplement

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

Study groups in NCT06871384
Study groupRoleWhat they receive
Nonalcoholic red wine group (Intervention group)ExperimentalMediteranean diet + nonalcoholic red wine
Receives: Dietary Supplement: Nonalcoholic red wine group (Intervention group)
Drinking water group (Control group)Placebo comparatorMediterranean diet + drinking water
Receives: Dietary Supplement: Drinking water group (Control group)

What is being measured

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

  1. Cognitive function

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

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

  2. Muscle strength

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

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

Secondary outcomes (76)

  1. Anthropometric measures

    WC: waist circumference (cm) measured by steel measuring tape (at the umbilicus)

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

  2. Anthropometric measures

    Height (cm) measured by wall-mounted stadiometer (Tanita Leicester Portable; Tanita Corp., Barcelona, Spain)

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

  3. Anthropometric measures

    Weight (kg) measured by calibrated scale (TANITA MC-780MA; Tanita Corp., Tokyo, Japan).

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

  4. Anthropometric measures

    BMI (kg/m2) calculated by weight (kg) divided to height (m2).

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

  5. Anthropometric measures

    Body composition (Fat mass (% and kg)) measured by calibrated scale (TANITA MC-780MA; Tanita Corp., Tokyo, Japan).

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

  6. Physical activity compliance

    International physical activity questionnaire for elderly: IPAQ for elderly IPAQ-E Spanish version (Rubio-Castañeda et al., 2017). Higher scores mean a better outcome.

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

  7. Sedentary habits

    Questionnaire developed by Marshall et al 2010. Higher amount of hours mean bad outcome.

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

  8. Sleep quality

    Pittsburgh questionnaire (Buysse et al., 1989). The maximum score is 21 points. More than 5 points are considered bad outcomes and sleep problems, and less than 5 points are considered better outcomes and no sleep problems.

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

  9. Life quality

    SF-36 Health survey questionnaire (Ware \& Sherbourne, 1992). Higher scores mean a better outcome.

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

  10. Depressive symptoms

    Geriatric Depression Scale Questionnaire (Yesavage et al., 1983). The maximum puntuation is 15. The score is 0-4 no depression, 5-8 mild depression, 9-11 moderate depression and 12-15 severe depression.

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

  11. Nutritional intake

    3-day dietary record

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

  12. Nutritional intake

    FFQ MD adherence to assess food groups intake (Martinez-Gonzalez et al., 2012) Higher scores mean a better outcome.

    Measured: Visit 1 (week 0), visit 2 (week 4), visit 3 (week 8), visit 4 (week 12), visit 5 (week 16), visit 6 (week 20), visit 7 (week 24), visit 8 (week 28), visit 9 (week 32), visit 10 (week 36))

  13. Nutritional status

    Mini Nutrition Assessment (MNA)

    Measured: Visit 0 (week -1)

  14. Nutritional status

    Total cholesterol (mmol/L) by standardized methods in an automated analyzer (Beckman Coulter-Synchron (Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  15. Nutritional status

    Albumin (g/dl) by standardized methods in an automated analyzer (Beckman Coulter-Synchron (Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  16. Nutritional status

    Haemoglobin (g/dl) by standardized methods in an automated analyzer (Beckman Coulter-Synchron (Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  17. Nutritional status

    Vitamin D (ng/ml) by standardized methods in an automated analyzer (Beckman Coulter-Synchron (Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  18. Nutritional status

    Vitamin A (ug/dl) by standardized methods in an automated analyzer (Beckman Coulter-Synchron (Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  19. Nutritional status

    Vitamin E (mg/L) by standardized methods in an automated analyzer (Beckman Coulter-Synchron (Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  20. Nutritional status

    Carotenoids (ug/dl) by standardized methods in an automated analyzer (Beckman Coulter-Synchron (Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  21. Cognitive function

    Spanish validated Mini Mental State Examination test (MMSE). The MMSE test various cognitive. The total test score ranges from 0 (impaired) to 30 (normal) (Beaman et al., 2004).

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

  22. Cognitive function

    AD8. The AD8 (Alzheimer disease questionnaire) aids in identifying cognitive impairment. This test in combination with the Fototest, significantly increases the diagnosis accuracy of both tests (Carnero Pardo et al., 2012). The optimal cut-off point was 3/4.

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

  23. Cognitive function

    TAM test. TAM test (Memory alteration test) provides efficient and valid screening for amnestic Mild Cognitive Impairment and early stage Alzheimer's disease, and discriminates between them. The cut-off score is of 28 points (Rami et al., 2007).

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

  24. Cognitive function

    Fototest. The Fototest is useful to identify cognitive impairment and dementia in routine clinical practice. (Carnero Pardo et al., 2007). The cut off points are 25/26 for dementia and 28/29 for cognitive impairment.

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

  25. Brain volume

    Nuclear Magnetic Resonance (NMR) Total brain volume, hippocampal volume, and volume of white matter hyperintense lesions will be evaluated in a subsample of participants. NMR have allowed important advances in the understanding of age-related brain changes. NMR is a non-invasive instrument that allows the study of the normal aging of individuals at different times of their lives (Barnes et al. 2023).

    Measured: Visit 1 (week 0), visit 10 (week 36)

  26. Cognitive ability assessment

    BDNF Brain-derived Neutrophic Factor (pg/ml) will be analyzed by Enzyme-linked immunosorbent assay ELISA kit in blood samples

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

  27. Skeletal muscle strength

    Isokinetic. Isokinetic test: the evaluation was conducted with an isokinetic dynamometer using a gold standard method (Biodex System 4; Biodex Medical Systems, NewYork, USA) by five repetitions sat two angular velocities (180°s-1, and240°s-1) (Solà et al., 2015). This allows a quantitative evaluation of muscle function through variables such as torque, work and power.

    Measured: Visit 1 (week 0), visit 10 (week 36)

  28. Muscle mass, wasting and turnover

    Muscle mass (skeletal muscle mass (kg)) assessed by Bioimpedance TANITA (MC-780MA; Tanita Corp., Tokyo, Japan).

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

  29. Muscle mass, wasting and turnover

    Muscle mass (appendicular skeletal muscle mass (kg)) assessed by Bioimpedance TANITA (MC-780MA; Tanita Corp., Tokyo, Japan).

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

  30. Muscle mass, wasting and turnover

    Muscle mass (skeletal muscle mass index (kg/m2)) assessed by Bioimpedance TANITA (MC-780MA; Tanita Corp., Tokyo, Japan).

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

  31. Muscle mass, wasting and turnover

    Muscle mass (appedicular skeletal muscle mass index (kg/m2)) assessed by Bioimpedance TANITA (MC-780MA; Tanita Corp., Tokyo, Japan).

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

  32. Muscle mass, wasting and turnover

    Muscle mass assessed by ultrasound (VINNO 5 (Vinno (Suzhou) Co., Ltd., China)

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

  33. Muscle mass, wasting and turnover

    Creatine kinase (U/L) assessed by enzymatic assays in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  34. Muscle mass, wasting and turnover

    Cystatin-C (mg/L) assessed by enzymatic assays in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  35. Muscle mass, wasting and turnover

    Serum Myostatin (ng/ml) assessed by commercial ELISA kits (Muscari et al., 2023)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  36. Muscle mass, wasting and turnover

    Serum Follistatin (ng/ml) assessed by commercial ELISA kits (Muscari et al., 2023)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  37. Physical performance

    Gait speed (m/s) assessed by the length of the walking course divided by the time (Ladang et al., 2023).

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

  38. Signalling pathways in skeletal muscle

    Muscle gene expression. A muscle biopsy (200-225 mg) will be obtained from a subgroup of volunteers (n=15/group) by trained physicians (Harper et al., 2021). After collection, these samples will be immediately snap frozen in liquid nitrogen and stored at -80°C prior to analysis. To confirm RNA sequencing results obtained in the animal model of age-associated sarcopenia (transcriptomic approach that will be carried out in gastrocnemius skeletal muscle as described in task 5.2), real-time gene expression analysis (qPCR) will be performed, as previously described (Pérez-Matute et al., 2016).

    Measured: Visit 1 (week 0), visit 10 (week 36)

  39. Biological age marker (Aging biomarker)

    Serum N-terminal pro-brain natriuretic peptide (NT-proBNP) (pg/ml) in blood samples (Muscari et al., 2023) is used to diagnose and establish prognosis for heart failure and is a promising biomarker of biological age as it correlates with chronological age and predict life span better than chronological age.

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

  40. Glucose homeostasis

    FBG (mmol/L) assessed by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  41. Glucose homeostasis

    Insulin (IU/mL) assessed by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  42. Glucose homeostasis

    HGBA1c (%) assessed by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  43. Glucose homeostasis

    HOMA index calculated (Winell et al., 2010) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  44. Glucose homeostasis

    IGF-1 (ng/ml) levels were measured using Human IGF-1 Quantikine ELISA Kit (Pérez-Matute et al., 2022) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  45. Lipid profile

    Total cholesterol (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  46. Lipid profile

    HDLc (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  47. Lipid profile

    LDLc (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  48. Lipid profile

    VLDLc (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  49. Lipid profile

    Total TG (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  50. Lipid profile

    NEFA (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  51. Lipid profile

    ApoA1 (mg/dL) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  52. Lipid profile

    ApoB100 (mg/dL) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  53. Lipid profile

    Apo B100/Apo A1 ratio in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  54. Lipid profile

    Lp (a) (mg/dL) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  55. Stress Response and Mitochondria

    GDF15 (pg/mL) Growth differentiating factor 15 is recgonized in mitochondria dysfunction, and as biomarker of aging (Justice et al., 2018) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  56. Oxidative markers

    OxLDL (ug/mL) assessed by commercial ELISA in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  57. Oxidative markers

    MetSO/Met (ng/mL) assessed by commercial ELISA in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  58. Oxidative markers

    SOD (U/g Hb) 20uL (abcam) in plasma EDTA blood samples assessed by enzymatic assays (Hissin et al., 1976)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  59. Oxidative markers

    GSHPx (nmol/mL) 50uL (abcam) plasma EDTA blood samples enzymatic assays (Hissin et al., 1976)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  60. Oxidative markers

    CoQ10 (ug/mL) in blood samples assessed by HPLC

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  61. Inflammation markers

    IL-6 (pg/mL) assessed by immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  62. Inflammation markers

    hsCRP (mg/L) assessed by immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  63. Inflammation markers

    TNFRII (pg/mL) assessed by commercial ELISA in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  64. Inflammation markers

    Adiponectin (ug/mL) assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  65. Inflammation markers

    Uric acid (mg/dL) assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  66. Vascular parameters

    Systolic and diastolic blood pressure (SBP and DBP) (mm Hg) and pulse pressure (PP) (mm Hg) assessed by automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).

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

  67. Biomarkers of endothelial dysfunction

    E-selectin (CD62E) (ng/mL) assessed by Commercial ELISA and multi-analyte ELISArray kits as described in our previous work (Catalán et al., 2015) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  68. Biomarkers of endothelial dysfunction

    P-selectin (CD62P) (ng/mL) assessed by Commercial ELISA and multi-analyte ELISArray kits as described in our previous work (Catalán et al., 2015) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  69. Biomarkers of endothelial dysfunction

    ICAM-1 (CD54) (ng/mL) assessed by Commercial ELISA and multi-analyte ELISArray kits as described in our previous work (Catalán et al., 2015) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  70. Biomarkers of endothelial dysfunction

    VCAM-1 (CD106) (ng/mL) assessed by Commercial ELISA and multi-analyte ELISArray kits as described in our previous work (Catalán et al., 2015) in blood samples

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  71. Faecal microbial composition

    Metataxonomic profile.

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  72. Faecal microbial function

    Microbial functional profile

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  73. Faecal metabolome

    SCFA acetic, butyric, propionic, isobutyric, valeric, isovaleric and caproic acid and phenol colonic metabolites

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  74. DNA methylation

    Epigeneitc age. Total genomic DNA will be extracted from saliva samples using the Norgen Saliva DNA Isolation Kit.

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  75. Gut permeability determined on plasma

    Zonulin (ng/mL). Human zonulin levels will be quantified using an ELISA kit (Cusabio® Technology Llc, Houston, TX, USA)

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

  76. Biomarkers of wine intake compliance

    Quantification of urine phenol metabolites in human elderly

    Measured: Visit 1 (week 0), visit 7 (week 24), visit 10 (week 36)

Timeline

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

  1. First posted11 Mar 2025
  2. Study start26 Mar 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06871384
Sponsor's protocol ID
WinAging Study
Other IDs
PID2023-148704OB-C22, PID2023-148704OB-C21
Acronym
WinAging
Status last verified
Mar 2026
First submitted
21 Feb 2025
Last updated
5 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jimenez-Ten Hoevel C, Girones I, Nicolas-Marzo J, Besora-Moreno M, Queral J, Valls RM, Perez-Matute P, Motilva MJ, Llaurado E, Sola R, Pedret A. Ultrasound-assessed abdominal fat distribution and its relation to sarcopenia parameters in community-dwelling young older adults: a cross-sectional study. Front Endocrinol (Lausanne). 2026 Jun 19;17:1888492. doi: 10.3389/fendo.2026.1888492. eCollection 2026.

    PubMed 42404338

Questions about this trial

What is this clinical trial studying?

A study testing Nonalcoholic red wine group (Intervention group) in people with Cognitive Disorders and Muscular Disorders, Atrophic, run by University Rovira i Virgili at 3 sites in Spain.

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 1 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Rosa Solà Alberich, Professor (+34 977 759 369, rosa.sola@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive function (time frame: Visit 0 (week -1), visit 1 (week 0), visit 4 (week 12), visit 7 (week 24), visit 10 (week 36)). The study lists 2 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 NCT06871384, which also lists 1 linked publication.

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 5 Mar 2026.

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