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Nutritional Intervention for Older Adults With Complete Dentures

16. september 2026 opdateret af: Camila Venegas, Universidad de La Frontera

Novel Dietary Guidelines for Elderly Denture-wearers to Ensure Adequate Nutritional Intake, Good Quality of Life and Enhanced Performance on Cognitive Tasks

The purpose of this clinical trial is to test a nutritional intervention. This study helps older adults who wear complete removable dentures improve their health.

The main questions the study aims to answer are:

  • What are the participants life experiences living with complete dentures before the intervention?
  • Does the intervention improve the diet quality of the participants?
  • Does the intervention improve nutritional status of the participants?
  • Does the intervention improve chewing performance and muscle strength?
  • Does the intervention increase the thickness of the masticatory muscles?
  • Does the intervention improve stress and muscle health markers in saliva?
  • Does the intervention improve cognitive performance and oral health-related quality of life?
  • Does the intervention improve cerebral blood flow? The study will include a total of 40 participants, who will be assigned to two groups. One group of 20 participants will receive the nutritional intervention, while the other group of 20 participants will maintain their usual diet during the study period. This comparison will allow the investigators to assess the effectiveness of the intervention.

Participants will:

  • Take part in a personal interview about their life experience with dentures.
  • Follow a dietary guide with recommendations on specific food textures for six months.
  • Receive personalized nutritional counseling and participate in healthy cooking workshops.
  • Use a custom-built mobile application to access the educational content of the nutritional guide, view instructional videos uploaded biweekly, and receive automated reminder notifications.
  • Attend clinical follow-up assessments, including chewing performance, muscle assessment, saliva markers, assessment of diet quality and nutritional status, cognitive tests, and oral health-related quality of life.
  • Complete these assessments at three main time points: baseline, 3 months, and 6 months.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This clinical trial evaluates the effectiveness of a multidimensional nutritional intervention on the functional, physiological, and cognitive health of older adults wearing complete removable dentures. The study employs a convergent parallel mixed-methods design to integrate quantitative with qualitative outcomes.

  1. Methodological Evaluation Protocols

    Participants will undergo comprehensive clinical and laboratory assessments:

    • Masticatory Function and Muscle Health: Chewing kinematics will be evaluated using 3D electromagnetic articulography (3D-EMA). Maximum bite force will be measured with a digital gnatodynamometer. Masticatory performance will be determined through a standardized peanut-sieving method. Additionally, masseter and temporalis muscle thickness will be assessed via ultrasonography.
    • Salivary Biomarkers: Saliva samples will be collected to quantify markers of physiological stress and muscle health: Cortisol, Insulin-like Growth Factor 1 (IGF-1), and Creatine Kinase (CK). Oxidative stress and antioxidant capacity will be analyzed using ROS, DPPH, and ORAC parameters.
    • Baseline Sociodemographic Characteristics: Sociodemographic characteristics will be collected at baseline using a structured questionnaire. The questionnaire will include information on age, sex, educational level, marital status, occupation or employment status, income level, and other relevant background variables.
    • Nutritional Status Assessment: Nutritional status will be monitored monthly through anthropometric measurements and body composition assessment. These include weight, height, body mass index (BMI), waist circumference, and body fat percentage determined by bioelectrical impedance analysis (BIA).
    • Cognitive Performance and Cerebral Blood Flow: Cognitive tasks will be evaluated using the Addenbrooke's Cognitive Examination-Revised (ACE-R) and a digital Stroop test to measure attention and executive function. Additionally, transcranial Doppler ultrasonography will be used to monitor cerebral blood flow.
    • Qualitative Dimension: Individual semi-structured interviews based on Grounded Theory will explore participants' life experiences regarding tooth loss, denture adaptation, and psychosocial barriers before and after the intervention.
  2. Intervention Logistics and Groups

The 40 participants will be randomly allocated into two balanced groups (20 participants per arm):

  • Intervention Group: Participants will receive a 6-month educational nutritional intervention. This will include in-person nutritional counseling before starting the intervention, and again during the 3rd and 6th months. In addition, telephone nutritional counseling will be provided during the 4th and 5th months. All counseling sessions will be delivered by a trained nutritionist. During the first nutritional counseling session, participants will receive a dietary guideline booklet for users of removable dentures. This guide was developed based on the results of the first stage of the project and promotes foods that support chewing function, as well as adherence to a Chilean-adapted Mediterranean diet. The guideline will also include healthy recipes. During the 2nd month of the study, participants will be invited to attend a practical workshop led by a nutritionist and a chef, where they will prepare recipes included in the dietary guide. All participants in the intervention group will receive a monthly food box containing non-perishable components of the diet. This intervention is complemented by a custom-developed mobile application tailored to meet the study's requirements. Through this app, participants can access the full nutritional guide in PDF format, view new educational and instructional videos uploaded biweekly, and receive automated push notifications as reminders to enhance usability and compliance.
  • Control Group: Participants will maintain their usual diet for 6 months and undergo the same follow-up assessments as the intervention group. To ensure ethical equity, at the end of the intervention, all participants in the control group will receive one food box, the dietary guideline for users of removable dentures, access to the mobile application, and will be invited to attend a practical workshop led by a nutritionist and a chef.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
40

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Chile
    • Cautín
      • Temuco, Cautín, Chile, 4780000

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Men and women aged 60 to 80 years.
  • Systemically healthy individuals or those with controlled chronic systemic conditions under regular medical supervision.
  • Functionally independent individuals, or those with a dedicated family member or caregiver available to provide support throughout the study period.
  • Wearers of both maxillary and mandibular complete removable dentures.
  • Adequate stability, retention, and functionality of both complete dentures allowing the participant to chew effectively during daily meals (accepting minor retention or stability limitations in the mandibular prosthesis, provided routine functional mastication is maintained).
  • Acceptable centric occlusion and jaw relationship allowing functional mastication.
  • Intact oral mucosa without active lesions or severe soreness in the denture-bearing areas.

Exclusion Criteria:

  • Altered salivary flow (hyposalivation or xerostomia) identified via anamnesis and sialometry, with an unstimulated salivary flow rate < 0.1 mL/min or a stimulated salivary flow rate < 0.5 mL/min.
  • Active oral mucosa diseases or lesions (e.g., cheilitis, denture stomatitis, ulcers, or aphthae) verified through intraoral examination.
  • Diagnosis of a major neurocognitive disorder by a qualified professional, verified via medical records and/or caregiver interview.
  • Color blindness (daltonism or color vision deficiency).
  • Presence of signs or symptoms of temporomandibular disorders (TMD).
  • Known history of allergy to peanuts or latex.
  • Underweight or severe undernutrition, defined as a Body Mass Index (BMI) < 18.5 kg/m².

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Intervention Group
Participants assigned to the Intervention Group will receive a 6-month educational and nutritional intervention designed for older adults who wear complete removable dentures. The intervention includes in-person nutritional consultation, telephone follow-up nutritional counseling, a dietary guideline booklet adapted for denture wearers, a practical healthy cooking workshop, and monthly food box delivery to support adherence. Additionally, the intervention will be supported by a custom-developed mobile application. Through this digital tool, participants can access the digital version of the dietary guide, view educational and instructional videos uploaded biweekly throughout the 6-month period.
Adfærdsmæssigt: Nutritional Intervention

This 6-month nutritional intervention for older adults wearing complete removable dentures consists of 6 components:

  1. In-person nutritional consultation: A trained nutritionist will provide dietary guidance, adapt recommendations to individual needs and support the initiation of dietary changes.
  2. Telephone follow-up: Monthly counseling sessions to monitor progress, address question and reinforce adherence to the intervention.
  3. Dietary guidelines booklet: Includes specific nutritional recommendations, weekly menu proposals, healthy recipes and guidance for incorporating foods with different textures and hardness levels, with the aim of stimulating masticatory function according to individual tolerance.
  4. Cooking workshop: Will teach participants how to prepare the recipes included in the dietary guidelines booklet.
  5. Food box delivery: Monthly supply of non-perishable ingredients.
  6. Mobile app: Digital tool providing the digital guide, educational videos and push notifications.
Ingen indgriben: Control Group
Participants assigned to the Control Group will maintain their usual diet during the 6-month study period and will undergo the same follow-up assessments as the Intervention Group. To ensure ethical equity, upon study completion, participants in the Control Group will receive full access to the mobile application, a food box, and the dietary guide booklet, and they will be invited to attend a practical healthy cooking workshop led by a nutritionist and a chef.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Masticatory Performance
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Measurement of food fractionation capacity. Participants will chew a standardized food (peanuts) for 20 cycles; the particles will be dried and processed through a sieving system (sieves from 4.0 mm to 870 μm) to determine the percentage of fractionation.
T0 (month 0), T1 (month 3) and T2 (month 6).
Diet Quality Assessment
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Diet quality will be assessed using the Chilean Healthy Eating Index (Índice de Dieta Mediterránea for Chile, IDM-Chile), which allows the evaluation of adherence to healthy dietary patterns in the study population.
T0 (month 0), T1 (month 3) and T2 (month 6).
Perceptions of Edentulism and Adaptation to Complete Removable Dentures
Tidsramme: Between month 0 and month 1 (collected during the initial phase of the study to capture prior experiences and avoid intervention bias).
A qualitative assessment using a Grounded Theory framework conducted through semi-structured individual interviews to explore older adults' perceptions regarding their experiences with tooth loss, rehabilitation with complete removable dental prostheses, and their natural functional and social adaptation strategies in daily life. Interviews (30-60 minutes) will be audio-recorded, transcribed verbatim, and analyzed concurrently using ATLAS.ti software through progressive coding (open, axial, and selective) to develop a substantive explanatory model.
Between month 0 and month 1 (collected during the initial phase of the study to capture prior experiences and avoid intervention bias).

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Masticatory Kinematics: Number of Chewing Cycles
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
The total number of chewing cycles recorded during the mastication of a standardized food (peanuts), quantified using a 3D electromagnetic articulograph (AG501).
T0 (month 0), T1 (month 3) and T2 (month 6).
Masticatory Kinematics: Chewing Cycle Area
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Assessment of chewing cycles focusing on the area, measured in square millimeters (mm²) using a 3D electromagnetic articulograph (AG501).
T0 (month 0), T1 (month 3) and T2 (month 6).
Masticatory Kinematics: Masticatory Frequency
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Assessment of the masticatory frequency during mastication, measured as the number of cycles per second (cycles/s) using a 3D electromagnetic articulograph (AG501).
T0 (month 0), T1 (month 3) and T2 (month 6).
Masticatory Kinematics: Masticatory Speed
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Assessment of chewing focusing on the movement velocity, measured in millimeters per second (mm/s) using a 3D electromagnetic articulograph (AG501).
T0 (month 0), T1 (month 3) and T2 (month 6).
Maximum Bite Force
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Measurement of maximum voluntary contraction in Newtons (N) using a digital gnathodynamometer placed between the first prosthetic molars.
T0 (month 0), T1 (month 3) and T2 (month 6).
Masticatory Muscles Thickness
Tidsramme: T0 (month 0) and T2 (month 6).
Evaluation of the thickness of the masseter and anterior temporalis muscles, measured in millimeters (mm) using a portable ultrasound device with a linear transducer.
T0 (month 0) and T2 (month 6).
Salivary Biomarkers: Cortisol
Tidsramme: T0 (month 0) and T2 (month 6).
Laboratory analysis of saliva samples to quantify cortisol concentration, a biomarker of physiological stress, samples will be analyzed using a Synergy HT Multimodal Reader (Biotek, USA). The outcome will be determined via enzyme-linked immunosorbent assay (ELISA) and expressed in nanograms per milliliter (ng/mL).
T0 (month 0) and T2 (month 6).
Salivary Biomarkers: Insulin-like Growth Factor 1 (IGF-1)
Tidsramme: T0 (month 0) and T2 (month 6).
Laboratory analysis of saliva samples to quantify Insulin-like Growth Factor 1 (IGF-1) concentration, a biomarker related to muscle health and growth, samples will be analyzed using a Synergy HT Multimodal Reader (Biotek, USA). The outcome will be determined via immunoassay and expressed in picograms per milliliter (pg/mL).
T0 (month 0) and T2 (month 6).
Salivary Biomarkers: Creatine Kinase (CK)
Tidsramme: T0 (month 0) and T2 (month 6).
Laboratory analysis of saliva samples to quantify Creatine Kinase (CK) enzymatic activity, a biomarker of muscle tissue stress and health, samples will be analyzed using a Synergy HT Multimodal Reader (Biotek, USA). The outcome will be determined via spectrophotometry and expressed in Units per liter (U/L).
T0 (month 0) and T2 (month 6).
Salivary Biomarkers: General Oxidative Stress (ROS)
Tidsramme: T0 (month 0) and T2 (month 6).
Laboratory analysis of saliva samples to quantify general oxidative stress by measuring reactive oxygen species (ROS) content. Saliva samples will be incubated with the CH2DCFDA fluorescent probe (30 uM) for 1 hour at 37°C in the dark. Fluorescence emission will be recorded at 530 nm using a Synergy HT multimodal reader (Biotek, USA), with H2O2 (100 uM) used as a positive control. The outcome will be reported as fluorescence intensity measured in Relative Fluorescence Units (RFU), where higher RFU values indicate a higher level of general oxidative stress.
T0 (month 0) and T2 (month 6).
Salivary Biomarkers: Total Antioxidant Capacity (TAC)
Tidsramme: T0 (month 0) and T2 (month 6).
Laboratory analysis of saliva samples to quantify total antioxidant capacity using the Oxygen Radical Absorbance Capacity (ORAC) method. The assay monitors the decay of fluorescein fluorescence (excitation/emission at 495/530 nm) over 120 minutes induced by AAPH free radicals, which is counteracted by the antioxidants in the sample. Readings will be captured every 2 minutes using a Synergy HT Multimodal Reader (Biotek, USA) and interpolated against a Trolox calibration curve. The outcome will be reported in millimoles of Trolox equivalents per milliliter of saliva (mmol TE/mL), where higher ORAC values indicate a greater total antioxidant capacity.
T0 (month 0) and T2 (month 6).
Oral Health-Related Quality of Life
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Evaluation of the impact of oral health on the patient's quality of life using the OHIP-7Sp questionnaire, validated for the elderly Chilean population. Total scores range from 0 to 28, where higher scores indicate poorer oral health-related quality of life.
T0 (month 0), T1 (month 3) and T2 (month 6).
Cognitive Performance: Addenbrooke's Cognitive Examination (ACE)
Tidsramme: T0 (month 0), T1 (month 3) and T2 (Month 6).
Evaluation of global cognitive status and its subdomains (orientation, attention, memory, language, and visuospatial skills) using the Chilean version of the Addenbrooke's Cognitive Examination (ACE). The outcome is measured using the instrument's total score, which ranges from 0 to 100 points, where higher scores indicate better global cognitive efficiency.
T0 (month 0), T1 (month 3) and T2 (Month 6).
Cognitive Performance: Stroop Test
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Evaluation of executive functions, including selective attention, cognitive flexibility, inhibition, and information processing speed, administered digitally via the "EncephalApp-Stroop Test" application on a tablet. The outcome is measured as the total completion time in seconds, where shorter execution times indicate better executive performance and cognitive control.
T0 (month 0), T1 (month 3) and T2 (month 6).
Cerebral Blood Flow: Mean Flow Velocity
Tidsramme: T0 (month 0) and T2 (month 6).
Assessment of cerebral hemodynamics at rest focusing on the mean flow velocity of the anterior and middle cerebral arteries to evaluate neurovascular coupling. Measurements will be recorded in centimeters per second (cm/s) through Transcranial Doppler ultrasonography using a PMD-100 system (Spencer Technologies, Redmond, USA) with a 2 MHz transducer at a depth of 5 cm. The assessment will be conducted by a specialized neurologist at the neurology service of the Dr. Hernán Henríquez Aravena Hospital (Temuco, Chile).
T0 (month 0) and T2 (month 6).
Cerebral Blood Flow: Pulsatility Index
Tidsramme: T0 (month 0) and T2 (month 6).
Assessment of cerebral hemodynamics at rest focusing on the pulsatility of the anterior and middle cerebral arteries to evaluate neurovascular coupling and cerebrovascular resistance. The outcome will be calculated as a dimensionless ratio value through Transcranial Doppler ultrasonography using a PMD-100 system (Spencer Technologies, Redmond, USA) with a 2 MHz transducer at a depth of 5 cm. The assessment will be conducted by a specialized neurologist at the neurology service of the Dr. Hernán Henríquez Aravena Hospital (Temuco, Chile).
T0 (month 0) and T2 (month 6).
Nutritional Status: Body Mass Index (BMI)
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Anthropometric evaluation of nutritional status. Participants weight (measured in kilograms) and height (measured in meters) will be aggregated to calculate and report the Body Mass Index (BMI), expressed in kilograms per square meter (kg/m²).
T0 (month 0), T1 (month 3) and T2 (month 6).
Nutritional Status: Waist Circumference
Tidsramme: T0 (month 0), T1 (month 3), and T2 (month 6).
Anthropometric assessment of abdominal fat distribution. Measurement of the participant's waist circumference, recorded in centimeters (cm) using a standardized non-elastic flexible tape measure.
T0 (month 0), T1 (month 3), and T2 (month 6).
Body Composition: Body Fat Percentage
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Evaluation of tissue body composition, specifically assessing the total body fat percentage (%), determined via bioelectrical impedance analysis (BIA).
T0 (month 0), T1 (month 3) and T2 (month 6).
Body Composition: Skeletal Muscle Mass Percentage
Tidsramme: T0 (month 0), T1 (month 3) and T2 (month 6).
Evaluation of muscular health and body composition, specifically assessing the skeletal muscle mass percentage (%), determined via bioelectrical impedance analysis (BIA).
T0 (month 0), T1 (month 3) and T2 (month 6).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Universidad de La Frontera

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Agencia Nacional de Investigación y Desarrollo

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Ramón Fuentes, PhD, Universidad de La Frontera
  • Studieleder: Camila Venegas, MSc, Universidad de La Frontera
  • Studieleder: Gladys Morales, PhD, Universidad de La Frontera
  • Studieleder: Carlos Zaror, PhD, Universidad de La Frontera

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
9. juli 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
12. maj 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
12. maj 2028

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
1. juli 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
7. juli 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
16. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 1230616 (Andet bevillings-/finansieringsnummer: Agencia Nacional de Investigación (ANID))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

To protect participant privacy and maintain data confidentiality, individual participant data will not be shared publicly. Final study results will be disseminated through peer-reviewed publications and doctoral thesis presentations.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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