- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07636369
The SAVOR Study: Appetite and Physiological Responses (SAVOR)
3. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
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 studie
Intervenční
Zápis (Odhadovaný)
20
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Rina Quek, MSc
- Telefonní číslo: 64074379
- E-mail: rina_quek@a-star.edu.sg
Studijní záloha kontaktů
- Jméno: Ashley Yu, BSc
- E-mail: ashley_yu@a-star.edu.sg
Studijní místa
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Singapore, Singapur
- Clinical Nutrition Research Centre
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Kontakt:
- Darel Toh, PhD
- Telefonní číslo: 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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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Ad Libitum Lunch
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Palatability questionnaire
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Health and Lifestyle questionnaire
Časové okno: Baseline measurement that is completed during screening visit
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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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Darel Toh, PhD, Clinical Nutrition Research Centre
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
1. srpna 2026
Dokončení studie (Odhadovaný)
1. října 2026
Termíny zápisu do studia
První předloženo
20. května 2026
První předloženo, které splnilo kritéria kontroly kvality
3. června 2026
První zveřejněno (Aktuální)
9. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
9. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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