Taste DisordersTASTENCT03196440
Sensitivity of Basic Taste in Elderly
An observational study of Taste Disorders, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
The purpose of this study is to identify the thresholds sensitivity of the five basic tastes in an elderly population and relate to food intake, nutritional status, age, gender and others variables. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Taste Disorders
- How many people
- 280 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jul 2015to 29 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Study population: Threshold sensitivity is applied to determine the threshold of 5 basic tastes in elderly in ambulatory care. It is applied mini mental test to evaluate cognition, considering that those who presented a score equal to or greater than 24 points. A 24-hour recall was applied to check food intake. The mini nutritional assessment was applied to verify nutritional status. Other information, such as diagnoses and medications, were obtained from medical records. Information on socioeconomic parameters were obtained through a questionnaire applied to the patient.
Who may be able to join
- 60 years old patient or older, who present oral feeding and the ability to express themselves to perform the sensory analysis tests will be included.
Who cannot join
- Patient with fever, flu, cold or some complication in the oral cavity will be excluded, since these factors can interfere in the perception of the tastes and those that do not present conditions to express themselves or deficits of cognition, being excluded the elderly that present result of the application of the Mini Mental under 24. In addition to those who do not agree to sign the Term of Free and Informed Consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thresholds Analysis of Five Basic Tastes in the Elderly Population
The purpose of this study is to identify the thresholds sensitivity of the five basic tastes in an elderly population and relate to food intake, nutritional status, age, gender and others variables.
Read the detailed description
The investigators propose a study of 300 elderly patients to characterize de sensitivity of the four basic tastes, according to the methodology of International Organization for Standardization (1985) and to identify umami taste (Mojet et al. 2001, 2003). This is a cross-sectional study. The length of the inclusion of the study will be 24 months. This study's general objective is: to characterize food intake, nutritional status and identify thresholds for the five basic tastes in an elderly population.
- Conditions
- Taste Disorders
- Keywords
- elderly, taste, thresholds
- Medical subject headings
- Taste Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of eldery according to sensitivity to basic tastes second age group and nutritional status
To identify the thresholds for detecting basic tastes in an elderly population and to relate to the age range and nutritional status.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start7 Jul 2015
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Taste DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor
- Investigators
- Ilana E. Grinberg, PhD, Principal investigator, Hospital Israelita Albert EinsteinLuciana DN Matos, PhD, Study chair, Hospital Israelita Albert EinsteinFabio GM Franco, PhD, Study director, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196440
- Sponsor's protocol ID
- 49306815.0.0000.0071
- Acronym
- TASTE
- Status last verified
- Jul 2016
- First submitted
- 20 Jun 2017
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
ELMAN, I.; GERALDO, A. P. G. ; KARCHER, C. ; SILVA, Maria Elisabeth Machado Pinto e . Caracterização dos limiares de detecção do gosto umami em crianças com e sem câncer. Revista Brasileira de Crescimento e Desenvolvimento Humano, v. 23, p. 136, 2013.
ELMAN, I.; SOARES, N. S. ; SILVA, Maria Elisabeth Machado Pinto e . Análise da Sensibilidade do Gosto Umami em Crianças com Câncer. Revista Brasileira de Cancerologia, v. 56, p. 237-242, 2010
ELMAN, I.; SILVA, Maria Elisabeth Machado Pinto e . Crianças portadoras de Leucemia Linfóide Aguda: análise dos limiares de detecção dos gostos básicos segundo sexo. Revista Brasileira de Cancerologia, v. 53, p. 297-303, 2007.
ELMAN, I.; SILVA, Maria Elisabeth Machado Pinto e . Crianças portadoras de câncer: sensibilidade ao PROP. Nutrição em Pauta, São Paulo, v. 4, n.79, p. 19-23, 2006.
ELMAN, I.. Apoyo nutricional a los ninos con cáncer. Proyecto Felicidade, Washington, p. 43-45, 2006.
SILVA, Maria Elisabeth Machado Pinto e ; PATON, Ive ; TRIGO, Marlene ; ELMAN, I. . Perfis socioeconômico e nutricional de crianças e adolescentes com câncer. Revista Brasileira de Nutrição Clínica, São Paulo, v. 19, n.3, p. 123-127, 2004.
GALDOLFO, Adriana S ; VIEIRA, Maria Aparecida ; ELMAN, I. . Oncologia. In: Ana Paula Alves da Silva; GA Corradi; Patricia Zamberlam. (Org.). Manual de dietas hospitalares em pediatria: Guia de Conduta Nutricional
Elman I. Cancer bearer children: Thresholds analysis of basic taste detection and sensivity to 6-n-propylthiouracil. São Paulo; 2005. [Dissertação de Mestrado - Faculdade de Saúde Pública da USP].
Elman I. Characterization of childen with câncer according to sensivity to umami and food consumption. [Tese de Doutorado em Nutrição e Saúde Pública]. São Paulo: Faculdade de Saúde Pública da USP; 2011.
Grinberg IE, de Mello Franco FG, Machado Pinto-e-Silva ME, Janot Matos LDN. Are there relationships between basic tastes, age, gender and nutritional status in an elderly population? World Journal of Advanced Research and Reviews, 2020, 07(02), 285-293
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thresholds Analysis of Five Basic Tastes in the Elderly Population
- ClinicalTrials.gov ID
- NCT03196440
- Acronym / sponsor ID
- TASTE / 49306815.0.0000.0071
- Conditions
- Taste Disorders
- Keywords
- elderly, taste, thresholds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the thresholds sensitivity of the five basic tastes in an elderly population and relate to food intake, nutritional status, age, gender and others variables.
Detailed description
The investigators propose a study of 300 elderly patients to characterize de sensitivity of the four basic tastes, according to the methodology of International Organization for Standardization (1985) and to identify umami taste (Mojet et al. 2001, 2003). This is a cross-sectional study. The length of the inclusion of the study will be 24 months. This study's general objective is: to characterize food intake, nutritional status and identify thresholds for the five basic tastes in an elderly population.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Threshold sensitivity is applied to determine the threshold of 5 basic tastes in elderly in ambulatory care. It is applied mini mental test to evaluate cognition, considering that those who presented a score equal to or greater than 24 points. A 24-hour recall was applied to check food intake. The mini nutritional assessment was applied to verify nutritional status. Other information, such as diagnoses and medications, were obtained from medical records. Information on socioeconomic parameters were obtained through a questionnaire applied to the patient.
Key inclusion criteria (1 listed)
- 60 years old patient or older, who present oral feeding and the ability to express themselves to perform the sensory analysis tests will be included.
Key exclusion criteria (1 listed)
- Patient with fever, flu, cold or some complication in the oral cavity will be excluded, since these factors can interfere in the perception of the tastes and those that do not present conditions to express themselves or deficits of cognition, being excluded the elderly that present result of the application of the Mini Mental under 24. In addition to those who do not agree to sign the Term of Free and Informed Consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of eldery according to sensitivity to basic tastes second age group and nutritional status
Time frame: 3 years
To identify the thresholds for detecting basic tastes in an elderly population and to relate to the age range and nutritional status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- BackgroundELMAN, I.; GERALDO, A. P. G. ; KARCHER, C. ; SILVA, Maria Elisabeth Machado Pinto e . Caracterização dos limiares de detecção do gosto umami em crianças com e sem câncer. Revista Brasileira de Crescimento e Desenvolvimento Humano, v. 23, p. 136, 2013.
- BackgroundELMAN, I.; SOARES, N. S. ; SILVA, Maria Elisabeth Machado Pinto e . Análise da Sensibilidade do Gosto Umami em Crianças com Câncer. Revista Brasileira de Cancerologia, v. 56, p. 237-242, 2010
- BackgroundELMAN, I.; SILVA, Maria Elisabeth Machado Pinto e . Crianças portadoras de Leucemia Linfóide Aguda: análise dos limiares de detecção dos gostos básicos segundo sexo. Revista Brasileira de Cancerologia, v. 53, p. 297-303, 2007.
- BackgroundELMAN, I.; SILVA, Maria Elisabeth Machado Pinto e . Crianças portadoras de câncer: sensibilidade ao PROP. Nutrição em Pauta, São Paulo, v. 4, n.79, p. 19-23, 2006.
- BackgroundELMAN, I.. Apoyo nutricional a los ninos con cáncer. Proyecto Felicidade, Washington, p. 43-45, 2006.
- BackgroundSILVA, Maria Elisabeth Machado Pinto e ; PATON, Ive ; TRIGO, Marlene ; ELMAN, I. . Perfis socioeconômico e nutricional de crianças e adolescentes com câncer. Revista Brasileira de Nutrição Clínica, São Paulo, v. 19, n.3, p. 123-127, 2004.
- BackgroundGALDOLFO, Adriana S ; VIEIRA, Maria Aparecida ; ELMAN, I. . Oncologia. In: Ana Paula Alves da Silva; GA Corradi; Patricia Zamberlam. (Org.). Manual de dietas hospitalares em pediatria: Guia de Conduta Nutricional
- BackgroundElman I. Cancer bearer children: Thresholds analysis of basic taste detection and sensivity to 6-n-propylthiouracil. São Paulo; 2005. [Dissertação de Mestrado - Faculdade de Saúde Pública da USP].
- BackgroundElman I. Characterization of childen with câncer according to sensivity to umami and food consumption. [Tese de Doutorado em Nutrição e Saúde Pública]. São Paulo: Faculdade de Saúde Pública da USP; 2011.
- Results publicationGrinberg IE, de Mello Franco FG, Machado Pinto-e-Silva ME, Janot Matos LDN. Are there relationships between basic tastes, age, gender and nutritional status in an elderly population? World Journal of Advanced Research and Reviews, 2020, 07(02), 285-293
- LattesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilana E. Grinberg, PhD principal investigator
Hospital Israelita Albert Einstein
Luciana DN Matos, PhD study chair
Hospital Israelita Albert Einstein
Fabio GM Franco, PhD study director
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Taste Disorders, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of eldery according to sensitivity to basic tastes second age group and nutritional status (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03196440, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.