Cancer- and Cancer Treatment-Related ConditionsNCT05651321
Studies on the Impact of Taste-aware Intelligent Analysis of Oral Nutritional Supplements
An observational study of Cancer- and Cancer Treatment-Related Conditions and Stroke, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this observational study is to test the taste perception threshold and palatability interval of different populations and the difference in taste perception between tumor and stroke patients and healthy people by combining manual sensory evaluation and electronic bionic sensory and investigate the taste… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer- and Cancer Treatment-Related Conditions, Stroke
- What is being tested?
- Samples materials of basic taste stimuli and enteral nutrition preparations
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Apr 2023to Dec 2024
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study subjects are healthy people, patients with specific diseases (after radiotherapy for tumors, stroke)
Who may be able to join
- healthy people aged 18-80 years old (including 18 and 80 years old), patients with specific diseases.
- specific diseases meet the clinical diagnosis criteria and are not in the clinical treatment period (such as radiotherapy or perioperative period)
- not wearing a denture and having good oral hygiene.
- normal vision or corrected vision, no hearing impairment, and no mental behavior disorder.
- voluntarily participate in this trial and sign the informed consent form.
Who cannot join
- subjects who may be allergic to the ingredients of the tested food
- persons who have an aversion to the food to be tasted or who do not consume the food for cultural, ethnic, or other reasons
- pregnant or lactating women.
- excessive smokers (>15 cigarettes/day) or heavy drinkers (>25g/day for men and >15g/day for women)
- Eating disorders (binge eating, anorexia, bulimia nervosa, etc.) and those who cannot eat through the mouth
- those who underwent ear, nose, and throat, transnasal intracranial occupancy, and oral surgery
Show all 10Show fewer
- Those who currently have severe abnormalities of the respiratory system, endocrine system, immune system, nervous system, circulatory system, digestive system, hematopoietic system, and nervous system, and those who have undergone bariatric surgery.
- currently taking medications that affect the sense of taste
- Subjects who are participating in other clinical trials.
- other people who have been determined by the investigator to be unsuitable for participation in this trial, patients with conditions that reduce the likelihood of enrollment or complicate enrollment, such as the presence of conditions that predispose to missed visits.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongcheng district，Peking union medical college hospital
Beijing, Beijing Municipality, 100010
Wei Chen, M.D., 010-69154095, txchenwei@sina.com
Xiaodong Shi, 17888811579
About this study
Official title: A Series of Studies on the Impact of Taste-aware Intelligent Analysis of Oral Nutritional Supplements on Patients' Nutritional Strategies
The goal of this observational study is to test the taste perception threshold and palatability interval of different populations and the difference in taste perception between tumor and stroke patients and healthy people by combining manual sensory evaluation and electronic bionic sensory and investigate the taste perception characteristics and demand of enteral nutrition preparations such as Fortimel in tumor and stroke patients, and the difference in taste perception of enteral nutrition preparations with healthy people by combining manual sensory evaluation and electronic bionic sensory. Participants were tested for different taste perception thresholds using a three-point difference test, with samples materials for basic taste stimuli used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) were used to prepare different tastes and concentrations of liquids. The subjects will then evaluate the appearance (color, texture), taste, flavor, and texture of the six different flavored enteral nutrition preparations. The subjects will then perform manual sensory evaluation of the appearance (color, texture), odor, taste, texture, and other properties of the 6 different flavored enteral nutrition preparations.
Read the detailed description
- Combining manual sensory evaluation and electronic bionic sensory, assessing the differences in taste perception between tumor and stroke patients and healthy individuals by measuring the basic taste perception threshold and palatability interval and analyzing facial expressions.
- Combining manual sensory evaluation with electronic bionic senses and simultaneous facial expression analysis to assess the taste perception characteristics and needs of tumor and stroke patients for different flavors of enteral nutrition preparations.
- Establishing an information base of electronic tongue taste data, facial expression emotion and flavor data of nutritional preparations based on the electronic tongue and facial expression data of relevant assays obtained simultaneously during the above experiments.
- Being tested
- Samples materials of basic taste stimuli and enteral nutrition preparations
- Medical subject headings
- Neoplasms, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples materials of basic taste stimuli and enteral nutrition preparationsOther
Samples materials of basic taste stimuli were used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) and six different flavored enteral nutrition preparations.
| Study group | Role | What they receive |
|---|---|---|
| stroke patients | Participants were tested for different taste perception thresholds using a three-point difference test, with samples materials for basic taste stimuli were used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) were used to prepare different tastes and concentrations of liquids. The subjects will then evaluate the appearance (color, texture), taste, flavor, and texture of the six different flavored enteral nutrition preparations. The subjects will then perform manual sensory evaluation of the appearance (color, texture), odor, taste, texture, and other properties of the 6 different flavored enteral nutrition preparations. Receives: Other: Samples materials of basic taste stimuli and enteral nutrition preparations | |
| cancer patients | Participants were tested for different taste perception thresholds using a three-point difference test, with samples materials for basic taste stimuli were used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) were used to prepare different tastes and concentrations of liquids. The subjects will then evaluate the appearance (color, texture), taste, flavor, and texture of the six different flavored enteral nutrition preparations. The subjects will then perform manual sensory evaluation of the appearance (color, texture), odor, taste, texture, and other properties of the 6 different flavored enteral nutrition preparations. Receives: Other: Samples materials of basic taste stimuli and enteral nutrition preparations | |
| healthy people | Participants were tested for different taste perception thresholds using a three-point difference test, with samples materials for basic taste stimuli were used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) were used to prepare different tastes and concentrations of liquids. The subjects will then evaluate the appearance (color, texture), taste, flavor, and texture of the six different flavored enteral nutrition preparations. The subjects will then perform manual sensory evaluation of the appearance (color, texture), odor, taste, texture, and other properties of the 6 different flavored enteral nutrition preparations. Receives: Other: Samples materials of basic taste stimuli and enteral nutrition preparations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste perception threshold
materials using basic taste stimuli, i.e. reference substances tartaric/citric acid (acid), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), quercetin/alum (astringent) to prepare Different flavors and concentrations of solutions were prepared. By the "three-point test", pure water was used as a control to determine the concentration of the flavors caused by The "discrimination threshold" of the sensation was determined by the "three-point test" using pure water as a control.
Measured: After initial screening and exclusion, subjects who met the inclusion criteria were ready to begin taste threshold testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study startApr 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer- and Cancer Treatment-Related ConditionsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Chen, Doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651321
- Sponsor's protocol ID
- ONSTaste2.0
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Series of Studies on the Impact of Taste-aware Intelligent Analysis of Oral Nutritional Supplements on Patients' Nutritional Strategies
- ClinicalTrials.gov ID
- NCT05651321
- Acronym / sponsor ID
- ONSTaste2.0
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Dec 2022 (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 goal of this observational study is to test the taste perception threshold and palatability interval of different populations and the difference in taste perception between tumor and stroke patients and healthy people by combining manual sensory evaluation and electronic bionic sensory and investigate the taste perception characteristics and demand of enteral nutrition preparations such as Fortimel in tumor and stroke patients, and the difference in taste perception of enteral nutrition preparations with healthy people by combining manual sensory evaluation and electronic bionic sensory. Participants were tested for different taste perception thresholds using a three-point difference test, with samples materials for basic taste stimuli used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) were used to prepare different tastes and concentrations of liquids. The subjects will then evaluate the appearance (color, texture), taste, flavor, and texture of the six different flavored enteral nutrition preparations. The subjects will then perform manual sensory evaluation of the appearance (color, texture), odor, taste, texture, and other properties of the 6 different flavored enteral nutrition preparations.
Detailed description
- Combining manual sensory evaluation and electronic bionic sensory, assessing the differences in taste perception between tumor and stroke patients and healthy individuals by measuring the basic taste perception threshold and palatability interval and analyzing facial expressions.
- Combining manual sensory evaluation with electronic bionic senses and simultaneous facial expression analysis to assess the taste perception characteristics and needs of tumor and stroke patients for different flavors of enteral nutrition preparations.
- Establishing an information base of electronic tongue taste data, facial expression emotion and flavor data of nutritional preparations based on the electronic tongue and facial expression data of relevant assays obtained simultaneously during the above experiments.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stroke patients | – | Other: Samples materials of basic taste stimuli and enteral nutrition preparationsParticipants were tested for different taste perception thresholds using a three-point difference test, with samples materials for basic taste stimuli were used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) were used to prepare different tastes and concentrations of liquids. The subjects will then evaluate the appearance (color, texture), taste, flavor, and texture of the six different flavored enteral nutrition preparations. The subjects will then perform manual sensory evaluation of the appearance (color, texture), odor, taste, texture, and other properties of the 6 different flavored enteral nutrition preparations. |
| cancer patients | – | Other: Samples materials of basic taste stimuli and enteral nutrition preparationsParticipants were tested for different taste perception thresholds using a three-point difference test, with samples materials for basic taste stimuli were used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) were used to prepare different tastes and concentrations of liquids. The subjects will then evaluate the appearance (color, texture), taste, flavor, and texture of the six different flavored enteral nutrition preparations. The subjects will then perform manual sensory evaluation of the appearance (color, texture), odor, taste, texture, and other properties of the 6 different flavored enteral nutrition preparations. |
| healthy people | – | Other: Samples materials of basic taste stimuli and enteral nutrition preparationsParticipants were tested for different taste perception thresholds using a three-point difference test, with samples materials for basic taste stimuli were used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) were used to prepare different tastes and concentrations of liquids. The subjects will then evaluate the appearance (color, texture), taste, flavor, and texture of the six different flavored enteral nutrition preparations. The subjects will then perform manual sensory evaluation of the appearance (color, texture), odor, taste, texture, and other properties of the 6 different flavored enteral nutrition preparations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects are healthy people, patients with specific diseases (after radiotherapy for tumors, stroke)
Key inclusion criteria (5 listed)
- healthy people aged 18-80 years old (including 18 and 80 years old), patients with specific diseases.
- specific diseases meet the clinical diagnosis criteria and are not in the clinical treatment period (such as radiotherapy or perioperative period)
- not wearing a denture and having good oral hygiene.
- normal vision or corrected vision, no hearing impairment, and no mental behavior disorder.
- voluntarily participate in this trial and sign the informed consent form.
Key exclusion criteria (10 listed)
- subjects who may be allergic to the ingredients of the tested food
- persons who have an aversion to the food to be tasted or who do not consume the food for cultural, ethnic, or other reasons
- pregnant or lactating women.
- excessive smokers (>15 cigarettes/day) or heavy drinkers (>25g/day for men and >15g/day for women)
- Eating disorders (binge eating, anorexia, bulimia nervosa, etc.) and those who cannot eat through the mouth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samples materials of basic taste stimuli and enteral nutrition preparationsSamples materials of basic taste stimuli were used, i.e. reference substances tartaric/citric acid (acidic), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), and quercetin/alum (astringent) and six different flavored enteral nutrition preparations. | Other | cancer patients, healthy people, stroke patients |
Primary outcome
Taste perception threshold
Time frame: After initial screening and exclusion, subjects who met the inclusion criteria were ready to begin taste threshold testing.
materials using basic taste stimuli, i.e. reference substances tartaric/citric acid (acid), quinine hydrochloride/caffeine (bitter), anhydrous sodium chloride (salty), sucrose (sweet), quercetin/alum (astringent) to prepare Different flavors and concentrations of solutions were prepared. By the "three-point test", pure water was used as a control to determine the concentration of the flavors caused by The "discrimination threshold" of the sensation was determined by the "three-point test" using pure water as a control.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
Related trials for Cancer- and Cancer Treatment-Related Conditions
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Not yet recruiting
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
Chronic Pain, Neuropathic Pain
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
Active, not recruiting
AKU Study - Acupuncture for Aromatase Inhibitor-Induced Musculoskeletal Syndrome
Aromatase Inhibitor-Associated Musculoskeletal Syndrome, Arthralgia Syndrome
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.
Wei Chen, Doctor principal investigator
Peking Union Medical College Hospital
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 Cancer- and Cancer Treatment-Related Conditions and Stroke, run by Peking Union Medical College Hospital at 1 site in China.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Chen, Doctor (+86 13911006820, chenw@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste perception threshold (time frame: After initial screening and exclusion, subjects who met the inclusion criteria were ready to begin taste threshold testing.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.