- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07636369
The SAVOR Study: Appetite and Physiological Responses (SAVOR)
3 czerwca 2026 zaktualizowane przez: Darel Toh, Singapore Institute of Food and Biotechnology Innovation
Seniors' Appetite: Vibrant Opportunities for Revitalization (SAVOR)
The study aims to identify key physiological factors that differentiate older adults with healthy appetites from those experiencing appetite decline.
The investigators hypothesize that seniors experiencing appetite decline will exhibit distinct oro-sensory, gastrointestinal, and hormonal profiles compared to seniors with healthy appetites, suggesting underlying biological mechanisms contributing to reduced appetite.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Szczegółowy opis
Appetite decline in older adults, or anorexia of aging, is a prevalent geriatric syndrome associated with decreased quality of life, increased risk of malnutrition, and accelerated decline in health.
While current nutritional guidelines often emphasize increasing nutrient density, these strategies often fail to address the root causes of diminished appetite.
Emerging research highlights the critical role of age-related physiological changes, particularly dysregulation of the gut-brain axis, altered sensory perception, and hormonal imbalances, in suppressing appetite.
Notably, existing evidence is largely derived from Western populations, which may not fully reflect the influence of cultural and lifestyle factors on appetite in Asian seniors.
This leaves a significant gap in understanding and addressing appetite loss within this specific demographic.
This study aims to address this gap by comprehensively investigating the physiological mechanisms underlying appetite regulation in Asian seniors, to identify key determinants that differentiate individuals with healthy appetites from those experiencing a decline.
By assessing the relationships between oro-sensory function, gastric dynamics, neuro-hormonal regulation, gut microbiome composition and subjective appetite, this study seeks to provide a deeper understanding of the biological pathways driving appetite differences in this population.
The findings of this study will lay the groundwork for future research aimed at developing culturally sensitive and effective interventions that can restore appetite, improve nutritional status, and ultimately enhance the health span and quality of life for older adults in Singapore and beyond.
Furthermore, this work has the potential to drive innovation in the food and nutrition industry, leading to the development of tailored products and dietary strategies that effectively address the unique nutritional needs of aging populations, ultimately impacting public health recommendations and policies related to senior nutrition.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
20
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Rina Quek, MSc
- Numer telefonu: 64074379
- E-mail: rina_quek@a-star.edu.sg
Kopia zapasowa kontaktu do badania
- Nazwa: Ashley Yu, BSc
- E-mail: ashley_yu@a-star.edu.sg
Lokalizacje studiów
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Singapore, Singapur
- Clinical Nutrition Research Centre
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Kontakt:
- Darel Toh, PhD
- Numer telefonu: 64074149
- E-mail: darel_toh@a-star.edu.sg
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Kontakt:
- Rina Quek, MSc
- E-mail: rina_quek@a-star.edu.sg
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- Postmenopausal female
- Aged 65-74 years
- Habitual breakfast consumer (consumes breakfast between 7am to 10am)
- Willingness to consume meals and follow intervention protocol
- English speaking
Exclusion Criteria:
- BMI ≥ 27.5
- Diagnosed with medical condition that may influence appetite or microbiome (e.g. diabetes, thyroid disorders, gastrointestinal diseases)
- Currently taking any medications or supplements that may influence appetite or the microbiome (e.g. probiotics, antibiotics, appetite stimulants/suppressants) one month prior to their first visit in consultation with study physician, PI and study team
- Following a special diet for weight management (e.g. low-calorie, low carbohydrate)
- History of bariatrics surgery
- Intentional attempt to change body weight or composition
- History of severe vasovagal syncope (blackouts or near faints) following blood draw
- Drug abuse within last 5 years
- Excessive alcoholic beverage consumption > 2 servings per day (1 serving defined as 360 mL beer, 150 mL wine or 45 mL distilled spirits)
- Smoking (cigarette, e-cigarette, cigar, pipe, vape)
- Engaging in habitual vigorous physical activity (as defined by physical activity questionnaire-PAQ)
- Loose teeth or jaw pain
- Not missing > 2 non-wisdom molars
- Involvement in other clinical studies that may influence the outcome of the study
- A study team member or their immediate family member
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Chicken porridge
Rice congee with shredded chicken and vegetable oil
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This is a mixed meal tolerance test intended to elicit gut hormone responses reflective of real-world dietary patterns.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Ad Libitum Lunch
Ramy czasowe: Participants will be given 30 minutes to consume the meal until they are comfortably full, 180 minutes after the start of the intervention.
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Participants will be asked to eat as much of the stir-fried beehoon as they want until they are comfortably full, to measure the exact calorie intake by weighing the food before and after eating.
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Participants will be given 30 minutes to consume the meal until they are comfortably full, 180 minutes after the start of the intervention.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Palatability questionnaire
Ramy czasowe: Administered after consuming test meal and after consuming the ad libitum meal.
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Palatability appetite questionnaire, rated on a visual analogue scale is a psychometric assessment tool where participants rate their subjective sensory experience-such as taste, smell, or pleasantness-by marking a point along a continuous 100 mm line anchored by opposing extremes (e.g., "extremely unpleasant" to "extremely pleasant").
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Administered after consuming test meal and after consuming the ad libitum meal.
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Appetite hormones
Ramy czasowe: Blood samples will be collected at timepoints (t = -15 minute (baseline), 30, 60, 90, 120 and 180 minutes)
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GLP-1, PYY and Acyl-ghrelin will be used to measure hormones related to appetite.
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Blood samples will be collected at timepoints (t = -15 minute (baseline), 30, 60, 90, 120 and 180 minutes)
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Subjective Appetite Questionnaire
Ramy czasowe: Measurement is taken at t = -15 minute (baseline), 10, 30, 60, 90, 120 and 180 minutes
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A subjective appetite questionnaire utilizes a Visual Analogue Scale to quantify a person's current metabolic state by measuring four key sensations: hunger, fullness, desire to eat, and prospective food consumption.
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Measurement is taken at t = -15 minute (baseline), 10, 30, 60, 90, 120 and 180 minutes
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Gastric Ultrasound
Ramy czasowe: Measurements will be taken at t = -15 minute (baseline), 15, 45, 105 and 165 minutes
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Gastric ultrasound will measure the gastric emptying rate postprandially.
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Measurements will be taken at t = -15 minute (baseline), 15, 45, 105 and 165 minutes
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Stool collected using the OMNIgene and OMNImet
Ramy czasowe: Baseline stool sample will be collected once between screening and intervention day.
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Stool sample will be collected in the OMNIgene-GUT and OMNImet-GUT tube for measurements that may include microbiome profiling, untargeted and targeted metabolome (e.g.
bile acids and short-chain fatty acids profiling).
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Baseline stool sample will be collected once between screening and intervention day.
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Olfactory Acuity (SCENTinel)
Ramy czasowe: Baseline measurement administered once during screening, takes approximately 5-10 minutes
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Olfactory acuity will be assessed using a simple, non-invasive SCENTinel rapid smell test.
Participants will be presented with test cards containing various odors, and will be asked to detect, rate, and identify the odors.
The test assesses the participant's ability to perceive and recognize smells, providing information on their overall sense of smell.
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Baseline measurement administered once during screening, takes approximately 5-10 minutes
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Taste Acuity Test (WETT)
Ramy czasowe: Baseline measurement administered once during screening, takes approximately 10-15 minutes
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The Waterless Empirical Taste Test (WETT) is a sensory method for assessing how well participants can recognise and detect basic tastes.
Participants will taste pre-moistened, paper-based test strips for the five basic tastes: sweet, sour, salty, bitter, and umami.
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Baseline measurement administered once during screening, takes approximately 10-15 minutes
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Blood plasma (Cytokines)
Ramy czasowe: t = -15 minute (baseline), 30, 60, 90, 120, 180 minutes
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Blood samples may also be analyzed for indicators of inflammation including cytokines testing
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t = -15 minute (baseline), 30, 60, 90, 120, 180 minutes
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Blood plasma (Bile acids and short-chain fatty acids profiling)
Ramy czasowe: t= -15 minute (baseline), 30, 60, 90, 120, 180 minutes
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Blood samples collected may be used to analyse biomarkers related to nutrition and digestive health e.g.
bile acid and short-chain fatty acids profiling
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t= -15 minute (baseline), 30, 60, 90, 120, 180 minutes
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Bite Strength
Ramy czasowe: Baseline measurement that may be administered once during screening or test session, as schedule and equipment permits. Takes only a few minutes.
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Bite strength will be measured using a bite force device (non-invasive) that records the maximum force a participant can exert while biting.
Multiple measurements will be taken with rest periods in between to prevent fatigue.
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Baseline measurement that may be administered once during screening or test session, as schedule and equipment permits. Takes only a few minutes.
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Tongue Strength (Tongue Pressure)
Ramy czasowe: Baseline measurement that may be administered once during screening or test session, as schedule and equipment permits. Takes approximately 5 minutes.
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Tongue pressure will be measured using a device equipped with a disposable air-filled bulb placed between the tongue and the hard palate.
Participants will be instructed to press the bulb with their tongue as firmly as possible for a few seconds.
Multiple measurements will be taken with rest periods in between to ensure accuracy and prevent fatigue.
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Baseline measurement that may be administered once during screening or test session, as schedule and equipment permits. Takes approximately 5 minutes.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Health and Lifestyle questionnaire
Ramy czasowe: Baseline measurement that is completed during screening visit
|
This questionnaire is to evaluate the participant's eligibility for the study.
It consist of participant information, medical and health history, lifestyle and diet, physical activity.
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Baseline measurement that is completed during screening visit
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3-day food record
Ramy czasowe: Administered between screening and actual test session, to be completed on 2 weekdays and 1 weekend.
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A 3-day food record is a detailed diary where participants document everything they eat and drink over two weekdays and one weekend day to provide an accurate snapshot of their typical nutritional intake.
This is done using household measures (or digital scales), where exact portion sizes, cooking methods and brand names of all items are used.
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Administered between screening and actual test session, to be completed on 2 weekdays and 1 weekend.
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Gastrointestinal Symptom Rating Scale (GSRS)
Ramy czasowe: Baseline measurement administered once during screening.
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The Gastrointestinal Symptom Rating Scale (GSRS) is a validated 15-item questionnaire used to assess the presence and severity of common digestive issues across five key areas: abdominal pain, reflux, diarrhea, constipation, and indigestion.
Participants rate each symptom on a 7-point Likert scale-ranging from "no discomfort" to "very severe discomfort"-to provide a quantifiable measurement of their gastrointestinal well-being.
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Baseline measurement administered once during screening.
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Council on Nutrition Appetite Questionnaire (CNAQ)
Ramy czasowe: Baseline measurement administered once during screening, takes approximately 5-10 minutes
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The Council on Nutrition Appetite Questionnaire (CNAQ) is a brief, 8-item screening tool designed to predict future weight loss by assessing a participant's appetite and dietary habits.
It asks about sensations like hunger, how quickly a participant feel full, and how food tastes to determine if a participant is at risk for nutritional deficiencies or significant weight changes over the coming months.
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Baseline measurement administered once during screening, takes approximately 5-10 minutes
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Pittsburgh Sleep Quality Index (PSQI)
Ramy czasowe: Baseline measurement administered once during screening, takes approximately 5-10 minutes
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The Pittsburgh Sleep Quality Index (PSQI) is a validated 19-item questionnaire used to measure sleep quality and disturbances over a one-month timeframe.
It evaluates seven key areas-including sleep duration, how long it takes to fall asleep, sleep disruptions, and daytime tiredness-to generate a single overall score that differentiates between "good" and "poor" sleepers in clinical research.
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Baseline measurement administered once during screening, takes approximately 5-10 minutes
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Geriatric Depression Scale (GDS)
Ramy czasowe: Administered once during screening, takes approximately 5 minutes
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The Geriatric Depression Scale (GDS) is a 30-item questionnaire-often shortened to a 15-item version-specifically designed to screen for depression in older adults.
Unlike general depression scales, it uses a simple "yes" or "no" format and focuses primarily on psychological and mood-related symptoms rather than physical complaints (like aches or fatigue), which can often overlap with normal aging or other medical conditions.
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Administered once during screening, takes approximately 5 minutes
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Dutch Eating Behavior Questionnaire (DEBQ)
Ramy czasowe: Baseline measurement administered once during screening, takes approximately 10 minutes
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The Dutch Eating Behavior Questionnaire (DEBQ) is a 33-item psychometric scale used to assess the distinct psychological factors and eating styles that can lead to overeating or weight gain.
It breaks eating behaviors down into three core subscales - emotional eating, external eating and restrained eating.
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Baseline measurement administered once during screening, takes approximately 10 minutes
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Leeds Food Preference Questionnaire (LFPQ)
Ramy czasowe: Baseline measurement administered once during screening, takes approximately 10-15 minutes
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The Leeds Food Preference Questionnaire (LFPQ) is a computer-based tool used in behavioral research to measure different psychological components of food preference and appetite.
It uses a series of food images to evaluate two distinct aspects of food reward: explicit liking and implicit wanting.
The tool categorizes these preferences across different food characteristics, specifically comparing high-fat vs. low-fat foods, and sweet vs. savory tastes.
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Baseline measurement administered once during screening, takes approximately 10-15 minutes
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Three-Factor Eating Questionnaire (TFEQ)
Ramy czasowe: Baseline measurement administered once during screening, takes approximately 10 minutes
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The Three-Factor Eating Questionnaire (TFEQ) is a validated psychometric tool used to measure three distinct dimensions of human eating behavior and cognitive dietary control.
It evaluates eating habits across three primary subscales: cognitive restraint, disinhibition and hunger
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Baseline measurement administered once during screening, takes approximately 10 minutes
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International Physical Activity Questionnaire (IPAQ)
Ramy czasowe: Baseline measurement administered once during screening, takes approximately 10 minutes
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The International Physical Activity Questionnaire (IPAQ) is a validated tool that measures a person's physical activity levels over a 7-day period.
It records the total time spent across four distinct intensities: vigorous activity (like running or heavy lifting), moderate activity (like steady cycling), walking, and weekday sitting time.
These tracked minutes are converted into a standard metabolic score (MET-minutes/week), which is then used to classify an individual's overall physical activity level into one of three distinct categories: Low, Moderate, or High.
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Baseline measurement administered once during screening, takes approximately 10 minutes
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Darel Toh, PhD, Clinical Nutrition Research Centre
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Sturm K, MacIntosh CG, Parker BA, Wishart J, Horowitz M, Chapman IM. Appetite, food intake, and plasma concentrations of cholecystokinin, ghrelin, and other gastrointestinal hormones in undernourished older women and well-nourished young and older women. J Clin Endocrinol Metab. 2003 Aug;88(8):3747-55. doi: 10.1210/jc.2002-021656.
- Dagbasi A, Warner J, Catterall V, Smith K, Crabtree DR, Carroll B, Frost G, Holliday A. Augmented gut hormone response to feeding in older adults exhibiting low appetite. Appetite. 2024 Oct 1;201:107415. doi: 10.1016/j.appet.2024.107415. Epub 2024 May 16.
- Atalayer D, Astbury NM. Anorexia of aging and gut hormones. Aging Dis. 2013 Oct 1;4(5):264-75. doi: 10.14336/AD.2013.0400264.
- Dagenais S, Fielding RA, Clark S, Cantu C, Prasad S, Groarke JD. Anorexia in Medicare Fee-for-Service Beneficiaries: A Claims-Based Analysis of Epidemiology and Mortality. J Nutr Health Aging. 2023;27(3):184-191. doi: 10.1007/s12603-023-1882-4.
- Morley JE. Peptides and aging: Their role in anorexia and memory. Peptides. 2015 Oct;72:112-8. doi: 10.1016/j.peptides.2015.04.007. Epub 2015 Apr 17.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 czerwca 2026
Zakończenie podstawowe (Szacowany)
1 sierpnia 2026
Ukończenie studiów (Szacowany)
1 października 2026
Daty rejestracji na studia
Pierwszy przesłany
20 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
9 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
9 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-133
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .