Tokyo, Nov. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059758) titled 'Effect of physical properties on ease of eating ice cream' on Nov. 13.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Meiji Co., Ltd.
Condition:
Condition - Men and women aged 75 or older
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluation of ease of consumption of ice cream with different physical properties
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - ice cream
Interventions/Control_2 - Ice cream with different physical properties from intervention 1
Eligibility:
Age-lower limit - 75
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Men and women aged 75 years or older on the day consent was obtained for this study.
2) Those who have been fully informed of the purpose and content of this study, are capable of consenting, fully understand the content of the study, and have volunteered of their own volition and agreed to participate in the study in writing.
Key exclusion criteria - 1) Persons with a history or current illness of the following:
Cerebrovascular disease
History of tumors related to swallowing
Diseases that affect swallowing function, including neurodegenerative and neuromuscular diseases
Respiratory disease
Upper digestive disease
Organic diseases of the larynx
2) Persons who have been diagnosed with a disorder related to eating and swallowing
3) Persons aged 70 or older who have been diagnosed with pneumonia
4) Persons with restrictions on food or fluid intake
5) Persons who have never eaten or do not like dry snacks (crackers, cookies, potato chips, rice crackers, etc.)
6) Persons with milk, wheat, or soybean allergies
7) Persons who require assistance when coming to the facility
8) Persons who have difficulty wearing the neckband
9) Persons who have difficulty understanding instructions
10) Other persons who the study manager, principal investigator, or representative investigator deems ineligible to be study subjects
Target Size - 20
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 08 Month 25 Day
Date of IRB - 2025 Year 08 Month 21 Day
Anticipated trial start date - 2025 Year 10 Month 06 Day
Last follow-up date - 2025 Year 11 Month 08 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068335
Disclaimer: Curated by HT Syndication.
