Studies on the Impact of Taste-aware Intelligent Analysis of Oral Nutritional Supplements

Stroke Clinical Trial

Official title:

A Series of Studies on the Impact of Taste-aware Intelligent Analysis of Oral Nutritional Supplements on Patients' Nutritional Strategies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651321
• Other study ID #: ONSTaste2.0
• Status: Recruiting
• Start date: April 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: Peking Union Medical College Hospital
• Contact: Wei Chen, Doctor
• Phone: +86 13911006820
• Email: chenw[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Description:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. healthy people aged 18-80 years old (including 18 and 80 years old), patients with specific diseases.

2. specific diseases meet the clinical diagnosis criteria and are not in the clinical treatment period (such as radiotherapy or perioperative period)

3. not wearing a denture and having good oral hygiene.

4. normal vision or corrected vision, no hearing impairment, and no mental behavior disorder.

5. voluntarily participate in this trial and sign the informed consent form.

Exclusion Criteria:

1. subjects who may be allergic to the ingredients of the tested food

2. persons who have an aversion to the food to be tasted or who do not consume the food for cultural, ethnic, or other reasons

3. pregnant or lactating women.

4. excessive smokers (>15 cigarettes/day) or heavy drinkers (>25g/day for men and >15g/day for women)

5. Eating disorders (binge eating, anorexia, bulimia nervosa, etc.) and those who cannot eat through the mouth

6. those who underwent ear, nose, and throat, transnasal intracranial occupancy, and oral surgery

7. 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.

8. currently taking medications that affect the sense of taste

9. Subjects who are participating in other clinical trials.

10. 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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Samples materials of basic taste stimuli and 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.

Locations

Country	Name	City	State
China	Dongcheng district,Peking union medical college hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After initial screening and exclusion, subjects who met the inclusion criteria were ready to begin taste threshold testing.