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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка 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 beetro
• Пищевая добавка 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

Первичные конечные точки

• Blood Pressure [Срок оценки: At baseline - 6 weeks - 12 weeks]
• Heart rate [Срок оценки: [Time Frame: Baseline - 6 weeks and 12 weeks]]
• Stroop Test [Срок оценки: At baseline - 6 weeks - 12 weeks]
• Symbol Digit Modalities Test (SDMT) [Срок оценки: At Baseline - 6 weeks - 12 weeks]
• Trail Making Test - A (TMT-A) [Срок оценки: At baseline - 6 weeks - 12 weeks]
• 6 minute walk test (6MWT) [Срок оценки: At baseline - 6 weeks - 12 weeks]
• Short Physical Performance Battery (SPPB) [Срок оценки: At baseline - 6 weeks - 12 weeks]
• Strength [Срок оценки: At baseline - 6 weeks - 12 weeks]
• Quality of life (QoL) [Срок оценки: At baseline - 12 weeks]
• Medication Use (Polypharmacy and Psychotropic Drugs) [Срок оценки: At baseline - 12 weeks]

Вторичные конечные точки (3)

• Continuous Glucose Monitoring [Срок оценки: During the first 15 days]
• Laboratory Parameters: Blood Nitrate and Nitric Oxide Assessment [Срок оценки: At baseline - 6 weeks - 12 weeks]
• Body Composition by Bioimpedance [Срок оценки: At baseline - 6 weeks - 12 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Hospital Universitario de Navarra — Pamplona

Идентификаторы

NCT: NCT07666685 · BERS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗