Beetroot Extract and Quality of Life in Adults Aged 75 and Over
NCT07666685, Not applicable, Recruiting, Fundacion Miguel Servet
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Beetroot Extract and Quality of Life in Adults Aged 75 and Over | ClinicalTrials.gov |
| NCT number | NCT07666685 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fundacion Miguel Servet | ClinicalTrials.gov |
| Conditions | Cardiovascular Health, Functional Health, Cognitive Function Decline, Physical Performance Decline in Older Adults | ClinicalTrials.gov |
| Interventions | Beetroot Extract Supplementation, Placebo group: nitrate-depleted beetroot juice | ClinicalTrials.gov |
| First posted | 2026-06-24 | ClinicalTrials.gov |
| Last updated | 2026-06-30 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Blood Pressure | 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. | ClinicalTrials.gov |
| Primary | Heart rate | [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. | ClinicalTrials.gov |
| Primary | Stroop Test | 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. | ClinicalTrials.gov |
| Primary | Symbol Digit Modalities Test (SDMT) | 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. | ClinicalTrials.gov |
| Primary | Trail Making Test - A (TMT-A) | 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. | ClinicalTrials.gov |
| Primary | 6 minute walk test (6MWT) | 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. | ClinicalTrials.gov |
| Primary | Short Physical Performance Battery (SPPB) | 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) | ClinicalTrials.gov |
| Primary | Strength | 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. | ClinicalTrials.gov |
| Primary | Quality of life (QoL) | 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. | ClinicalTrials.gov |
| Primary | Medication Use (Polypharmacy and Psychotropic Drugs) | 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 | ClinicalTrials.gov |
| Primary | Sleep Health Index (SATED) | 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. | ClinicalTrials.gov |
| Primary | Nutritional Status | At baseline | Mini Nutritional Assessment (MNA) ranges from normal nutritional status (24-30points), risk of malnutrition (17-23.5points), or malnourished(\<17points). | ClinicalTrials.gov |
| Primary | Barthel Index | At baseline | Barthel Index of independence during activities of dailyliving (ADLs) ranges from 0 (severe functional dependence) to 100 (functional independence). | ClinicalTrials.gov |
| Primary | International Physical Activity Questionnaire (IPAQ) | 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. | ClinicalTrials.gov |
| Primary | Mini-Mental State Examination (MMSE) | 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. | ClinicalTrials.gov |
| Secondary | Continuous Glucose Monitoring | 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. | ClinicalTrials.gov |
| Secondary | Laboratory Parameters: Blood Nitrate and Nitric Oxide Assessment | 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. | ClinicalTrials.gov |
| Secondary | Body Composition by Bioimpedance | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)