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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Health; Cognitive Function Decline; Physical Performance Decline in Older Adults; Functional Health
• Intervention / Treatment: Dietary supplement: Placebo group: nitrate-depleted beetroot juice; Dietary supplement: Beetroot Extract Supplementation

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Martinez-Velilla, Md-PhD; Phone Number: 00 34 848422222; Email: nicolas.martinez.velilla@navarrra.es
• Study Contact Backup: Name: Fabricio Zambom-Ferraresi, PhD; Phone Number: 00 34 848422222; Email: fabricio.zambom.ferraresi@navarra.es

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Hospital Universitario de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control Group; Participants receive a placebo (nitrate-depleted beetroot juice) and continue with their usual daily activities without any additional intervention.	Dietary supplement: 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.
Experimental: Beetroot Extract Supplementation; Participants receive daily supplementation with beetroot extract juice and continue with their usual daily activities.	Dietary supplement: 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.
Experimental: 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.	Dietary supplement: 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.
Active Comparator: 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).	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	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	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)	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)	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)	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)	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	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)	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)	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)	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	Mini Nutritional Assessment (MNA) ranges from normal nutritional status (24-30points), risk of malnutrition (17-23.5points), or malnourished(<17points).	At baseline
Barthel Index	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)	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)	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Glucose Monitoring	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	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	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

Collaborators and Investigators

• Sponsor: Fundacion Miguel Servet
• Investigators: Principal Investigator: Nicolas Martinez-Velilla, MD-PhD, Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; cognitive function; cardiovascular health; functional health; dietary nitrate; beetroot extract
• Other Study ID Numbers: BERS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No