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Beetroot Extract and Quality of Life in Adults Aged 75 and Over (BERS)

26 giugno 2026 aggiornato da: Fundacion Miguel Servet

Assessment of the Benefits of Beetroot Extract for Improving the Quality of Life of Older People: a Randomised Clinical Trial.

The increasing number of adults aged 75 years and older highlights the need for effective, low-cost interventions to preserve cardiovascular health, functional independence, and cognitive performance and to support healthy aging. Beetroot extract (BE), derived from "Beta vulgaris", contains high levels of inorganic nitrate and other bioactive compounds that may positively influence vascular and neuromuscular function. In parallel, multicomponent physical exercise is recognized as an effective strategy to improve physical and cognitive outcomes in older adults. However, evidence on the independent and combined effects of BE supplementation and structured exercise in very old adults remains limited.

This randomized controlled trial is designed to evaluate the effects of BE supplementation, alone and in combination with a multicomponent physical exercise program, on blood pressure, functional performance, and cognitive function in adults aged 75 years and older. Participants will be randomly assigned to one of four groups: BE supplementation, multicomponent exercise, combined BE supplementation and exercise, or a control condition, over a predefined intervention period. The exercise program will include strength, balance, mobility, and aerobic components specifically adapted to the abilities and safety requirements of old adults.

The primary outcomes of the study will assess changes in cardiovascular health, physical and functional performance, and cognitive function using standardized and validated assessment tools. Secondary outcomes will include additional indicators of physical capacity and health-related quality of life. This trial aims to provide clinically relevant evidence on whether BE supplementation, alone or in combination with multicomponent exercise, represents a practical and scalable intervention to improve cardiovascular, functional, and cognitive health in adults aged 75 years and older.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Spagna
    • Navarre
      • Pamplona, Navarre, Spagna, 31008
        • Reclutamento
        • Hospital Universitario de Navarra

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  1. Adults aged 75 years and older recruited from the Geriatrics Service of the Hospital Universitario de Navarra (HUN) or primary care settings.
  2. Ability to ambulate independently.
  3. Ability to communicate effectively.
  4. Ability to tolerate physical exercise.
  5. Barthel Index score greater than 60 points.

Exclusion Criteria:

  1. Refusal or inability of the participant, caregiver, or legal guardian to provide written informed consent.
  2. Advanced or severe dementia (Global Deterioration Scale [GDS] stages 6-7).
  3. Unstable medical condition or terminal illness with a life expectancy of less than 6 months.
  4. Ischemic heart disease or congestive heart failure.
  5. Severe renal insufficiency.
  6. Hypotension.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo Control Group
Participants receive a placebo (nitrate-depleted beetroot juice) and continue with their usual daily activities without any additional intervention.
Integratore alimentare: Placebo group: nitrate-depleted beetroot juice
Participants receive daily supplementation with nitrate-depleted beetroot juice, with or without participation in a multicomponent physical exercise program, according to group allocation. The placebo juice is derived from beetroot but has had its nitrate content removed, maintaining similar appearance, taste, and texture to the active supplement. When applicable, the exercise program targets strength, balance, mobility, and aerobic capacity and is supervised by trained professionals during the first 6 weeks, followed by a prescribed but unsupervised phase for the subsequent 6 weeks. This placebo-controlled intervention is designed to isolate the effects of dietary nitrate from beetroot extract and to evaluate the independent and combined effects of physical exercise on cardiovascular, functional, and cognitive outcomes in adults aged 75 years and older.
Sperimentale: Beetroot Extract Supplementation
Participants receive daily supplementation with beetroot extract juice and continue with their usual daily activities.
Integratore alimentare: Beetroot Extract Supplementation
Participants receive daily supplementation with beetroot extract juice, with or without participation in a multicomponent physical exercise program, depending on group allocation. When applicable, the exercise program targets strength, balance, mobility, and aerobic capacity, and is supervised by trained professionals during the first 6 weeks and subsequently prescribed but not supervised for the following 6 weeks. This intervention aims to evaluate the independent and combined effects of beetroot extract supplementation and physical exercise on cardiovascular, functional, and cognitive outcomes in adults aged 75 years and older.
Sperimentale: Beetroot Extract Plus Multicomponent Exercise
Participants engage in a multicomponent physical exercise program, supervised during the first 6 weeks and then prescribed but not supervised for the following 6 weeks, combined with daily supplementation of beetroot extract juice.
Integratore alimentare: Beetroot Extract Supplementation
Participants receive daily supplementation with beetroot extract juice, with or without participation in a multicomponent physical exercise program, depending on group allocation. When applicable, the exercise program targets strength, balance, mobility, and aerobic capacity, and is supervised by trained professionals during the first 6 weeks and subsequently prescribed but not supervised for the following 6 weeks. This intervention aims to evaluate the independent and combined effects of beetroot extract supplementation and physical exercise on cardiovascular, functional, and cognitive outcomes in adults aged 75 years and older.
Comparatore attivo: Placebo Plus Multicomponent Exercise
Participants engage in a multicomponent physical exercise program, supervised during the first 6 weeks and then prescribed but not supervised for the following 6 weeks, combined with placebo supplementation (nitrate-depleted beetroot juice).
Integratore alimentare: Placebo group: nitrate-depleted beetroot juice
Participants receive daily supplementation with nitrate-depleted beetroot juice, with or without participation in a multicomponent physical exercise program, according to group allocation. The placebo juice is derived from beetroot but has had its nitrate content removed, maintaining similar appearance, taste, and texture to the active supplement. When applicable, the exercise program targets strength, balance, mobility, and aerobic capacity and is supervised by trained professionals during the first 6 weeks, followed by a prescribed but unsupervised phase for the subsequent 6 weeks. This placebo-controlled intervention is designed to isolate the effects of dietary nitrate from beetroot extract and to evaluate the independent and combined effects of physical exercise on cardiovascular, functional, and cognitive outcomes in adults aged 75 years and older.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Heart rate
Lasso di tempo: [Time Frame: Baseline - 6 weeks and 12 weeks]
Heart rate will be measured at rest, after the 6-minute walk test, and then 3 minutes after the test has finished.
[Time Frame: Baseline - 6 weeks and 12 weeks]
Stroop Test
Lasso di tempo: At baseline - 6 weeks - 12 weeks
This test measures cognitive control and attention by asking individuals to name the color of a word rather than the word itself. It evaluates the ability to manage interference between conflicting information.
At baseline - 6 weeks - 12 weeks
Symbol Digit Modalities Test (SDMT)
Lasso di tempo: At Baseline - 6 weeks - 12 weeks
This test assesses processing speed, attention, and working memory by requiring individuals to match symbols with corresponding numbers under time pressure. Faster and more accurate performance indicates better cognitive functioning.
At Baseline - 6 weeks - 12 weeks
Trail Making Test - A (TMT-A)
Lasso di tempo: At baseline - 6 weeks - 12 weeks
This test evaluates visual attention and task switching by asking individuals to connect a sequence of numbers (Part A). It measures cognitive flexibility, speed, and executive function.
At baseline - 6 weeks - 12 weeks
6 minute walk test (6MWT)
Lasso di tempo: At baseline - 6 weeks - 12 weeks
This test measures functional exercise capacity by assessing how far a person can walk in six minutes on a flat surface. It reflects endurance and helps evaluate cardiovascular, respiratory, and musculoskeletal function.
At baseline - 6 weeks - 12 weeks
Short Physical Performance Battery (SPPB)
Lasso di tempo: At baseline - 6 weeks - 12 weeks
Physical Function: Assessed using the Short Physical Performance Battery (SPPB), which combines balance, gait velocity, and leg strength as a single score on a 0 (worst) to 12 (best scale)
At baseline - 6 weeks - 12 weeks
Strength
Lasso di tempo: At baseline - 6 weeks - 12 weeks
Handgrip strength and maximal concentric strength (leg press, chest press, knee extension, seated row machine). Changes in "1RM", defined as the maximum resistance/load a person can move in one repetition of an exercise will be assessed. These values are mesured in Kilograms and results are individualized.
At baseline - 6 weeks - 12 weeks
Quality of life (QoL)
Lasso di tempo: At baseline - 12 weeks
Measurment of quality of life using EQ5D-3L, the patients indicate their health state by choosing one level for each of the five dimensions, creating a 5-digit code representing 243 possible health states. EQ VAS, includes a vertical Visual Analogue Scale (0-100) where patients rate their self-rated health, with 100 being the "best imaginable health state". Utility. The responses can be converted into a single index value (utility score) using country-specific valuation sets, where 1 represents full health and 0 represents death.
At baseline - 12 weeks
Medication Use (Polypharmacy and Psychotropic Drugs)
Lasso di tempo: At baseline - 12 weeks
Number and type of medications will be recorded. Polypharmacy will be defined as the use of ≥5 medications. Psychotropic drug use and medications related to comorbid or intercurrent conditions (e.g., antibiotics) will also be documented
At baseline - 12 weeks
Sleep Health Index (SATED)
Lasso di tempo: At baseline - 12 weeks
SATED : This questionnaire assesses sleep health across five dimensions: Satisfaction, Alertness, Timing, Efficiency, and Duration. It provides a brief evaluation of overall sleep quality and habits.
At baseline - 12 weeks
Nutritional Status
Lasso di tempo: At baseline
Mini Nutritional Assessment (MNA) ranges from normal nutritional status (24-30points), risk of malnutrition (17-23.5points), or malnourished(<17points).
At baseline
Barthel Index
Lasso di tempo: At baseline
Barthel Index of independence during activities of dailyliving (ADLs) ranges from 0 (severe functional dependence) to 100 (functional independence).
At baseline
International Physical Activity Questionnaire (IPAQ)
Lasso di tempo: At baseline
This questionnaire measures physical activity levels by asking about the frequency and duration of different intensities of activity. It is used to estimate total physical activity and categorize individuals into activity levels.
At baseline
Mini-Mental State Examination (MMSE)
Lasso di tempo: At baseline
This test is a brief screening tool used to assess cognitive function, including orientation, memory, attention, language, and visuospatial skills. It helps identify cognitive impairment and monitor changes over time.
At baseline
Blood Pressure
Lasso di tempo: At baseline - 6 weeks - 12 weeks
Blood pressure (systolic and diastolic) will be measured three times in a row, and the average of the three readings will be calculated.
At baseline - 6 weeks - 12 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Continuous Glucose Monitoring
Lasso di tempo: During the first 15 days
Continuous Glucose Monitoring (FreeStyle Libre 2): This system measures glucose levels continuously through a small sensor placed on the skin, providing real-time data without frequent finger pricks. It helps track glucose trends and fluctuations, supporting better diabetes management and treatment decisions.
During the first 15 days
Laboratory Parameters: Blood Nitrate and Nitric Oxide Assessment
Lasso di tempo: At baseline - 6 weeks - 12 weeks
Blood Nitrate and Nitric Oxide Assessment: This measurement evaluates nitric oxide (NO) bioavailability by analyzing changes in blood nitrate levels, a stable indirect marker of NO production, typically expressed in µmol/L. . Blood samples (10-20 mL) will be collected alongside routine clinical testing using Vacutainer tubes (EDTA, citrate, or serum tubes as appropriate). Samples will be left upright for 10 minutes and centrifuged at 3000 rpm for 15 minutes to obtain serum and plasma for analysis. Aliquots will be stored at -80°C for future specialised analyses, including flow cytometry.
At baseline - 6 weeks - 12 weeks
Body Composition by Bioimpedance
Lasso di tempo: At baseline - 6 weeks - 12 weeks
Body Composition by Bioimpedance (BIA 101 BIVA® PRO): This method assesses body composition by measuring electrical impedance through a two-electrode system, providing estimates of body water, fat mass, and fat-free mass. It also uses bioelectrical impedance vector analysis (BIVA) to evaluate hydration status and cellular health, offering insights into nutritional and physiological condition.
At baseline - 6 weeks - 12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fundacion Miguel Servet

Investigatori

  • Investigatore principale: Nicolas Martinez-Velilla, MD-PhD, Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 marzo 2026

Completamento primario (Stimato)

1 ottobre 2027

Completamento dello studio (Stimato)

1 novembre 2027

Date di iscrizione allo studio

Primo inviato

26 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • BERS

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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