Beetroot Extract and Quality of Life in Adults Aged 75 and Over

NCT07666685 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-30

No results posted yet for this study

Summary

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.

Conditions

  • Cardiovascular Health
  • Functional Health
  • Cognitive Function Decline
  • Physical Performance Decline in Older Adults

Interventions

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.

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.

Sponsors & Collaborators

  • Fundacion Miguel Servet

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-24
Primary Completion
2027-10-31
Completion
2027-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07666685 on ClinicalTrials.gov