Assessment of the Benefits of Beetroot Extract for Improving the Quality of Life of Older People: a Randomised Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
The professionals delivering the execise interventions are blinded to beetroot extract or placebo allocation.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo Control Group
Participants receive a placebo (nitrate-depleted beetroot juice) and continue with their usual daily activities without any additional intervention.
干预措施: Placebo group: nitrate-depleted beetroot juice (Dietary Supplement)
Beetroot Extract Supplementation
Participants receive daily supplementation with beetroot extract juice and continue with their usual daily activities.
干预措施: Beetroot Extract Supplementation (Dietary Supplement)
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.
干预措施: Beetroot Extract Supplementation (Dietary Supplement)
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).
干预措施: Placebo group: nitrate-depleted beetroot juice (Dietary Supplement)
结局指标
主要结局
Blood Pressure
时间窗: 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.
次要结局
未报告次要终点