- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05651321
Studies on the Impact of Taste-aware Intelligent Analysis of Oral Nutritional Supplements
April 10, 2023 updated by: Peking Union Medical College Hospital
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wei Chen, Doctor
- Phone Number: +86 13911006820
- Email: chenw@pumch.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100010
- Recruiting
- Dongcheng district,Peking union medical college hospital
-
Contact:
- Wei Chen, M.D.
- Phone Number: 010-69154095
- Email: txchenwei@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Study subjects are healthy people, patients with specific diseases (after radiotherapy for tumors, stroke)
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
After initial screening and exclusion, subjects who met the inclusion criteria were ready to begin taste threshold testing.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wei Chen, Doctor, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2023
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
December 5, 2022
First Submitted That Met QC Criteria
December 5, 2022
First Posted (Actual)
December 15, 2022
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- ONSTaste2.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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