Tokyo, Aug. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056070) titled 'The study of the effects of a test food on saliva secretion' on Aug. 27.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Healthy male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effects of saliva secretion when test food is ingested.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consume one test tablet by allowing it to dissolve in the mouth (on the tongue) without chewing
Interventions/Control_2 - Consume one placebo tablet by allowing it to dissolve in the mouth (on the tongue) without chewing
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1. Male and female aged 40 to below 70 years at the time of consent acquisition.
2.Individuals who are aware that their mouth tends to dry out easily.
3. Individuals with a baseline resting saliva secretion of 1.5 g or more during preliminary testing.
4. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria - 1. Individuals who consume foods or supplements containing dihydrocapsiate, coenzyme Q10, eriodictyol-6-C-glucoside, or similar compounds that could affect the trial, including Foods with Function Claims, functional food labels, and health supplements, more than once a week and cannot discontinue their use from the time of consent.
2. Individuals who cannot discontinue the intake of dihydrocapsiate, coenzyme Q10, eriodictyol-6-C-glucoside, or similar compounds included in Foods with Function Claims, functional food labels, and health supplements from the time of consent.
3. Individuals who are taking medications that could affect the trial, such as antihypertensives, antihistamines, antiepileptics, anti-Parkinson drugs, and sedatives.
4. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
5. Smokers, except for those who have abstained from smoking for more than one year.
6. Individuals with excessive alcohol intake.
7. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
8. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
9. Individuals with allergies to medications and/or food.
10. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target Size - 40
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 10 Month 21 Day
Date of IRB - 2024 Year 10 Month 18 Day
Anticipated trial start date - 2024 Year 11 Month 08 Day
Last follow-up date - 2025 Year 01 Month 08 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063768
Disclaimer: Curated by HT Syndication.
