Tokyo, Dec. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059942) titled 'An Exploratory Study on the Effects of a Test Food Product on Physical Performance, Immune Function, and Cognitive Function' on Dec. 2.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of consuming a test food product on the maintenance of physical performance, immune function, and cognitive function in middle-aged and older adults.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral consumption of the test food (1 capsule, once daily) for 8 weeks
Interventions/Control_2 - Oral consumption of the placebo food (1 capsule, once daily) for 8 weeks
Eligibility:
Age-lower limit - 55
years-old
Gender - Male and Female
Key inclusion criteria - 1. Males and females aged 55 years to less than 70 years at the time of informed consent acquisition.
2. 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 engaged in physically demanding occupations such as heavy lifting.
2. Individuals who have maintained a habitual exercise routine for more than 1 year, consisting of 30 minutes or over of exercise at least twice per week. (Light daily activities such as casual walking are not considered habitual exercise; however, resistance training, dance, ball sports, and similar structured exercise are included.)
3. Individuals with irregular lifestyle patterns, including rotating shift work.
4. Individuals who have sustained injuries affecting physical function (e.g., fractures, tendon ruptures) within the past year.
5. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims (e.g., products marketed for reducing fatigue) and are unable to discontinue their use after providing consent.
6. Individuals who have routinely taken supplements containing vitamin D, amino acids, or polyunsaturated fatty acids (DHA/EPA) within the past 3 months, and are unable to discontinue their use after providing consent.
7. Individuals who routinely take medications or quasi-drugs that may affect the study outcomes (e.g., nutritional tonics for physical fatigue, restorative tonics, antibiotics, DHA/EPA-containing products) and who are unable to discontinue their use after providing consent.
8. Individuals who have taken steroids or hormonal agents (e.g., androgen- or estrogen-containing compounds) that may affect muscle function within the past 3 months, and those who cannot discontinue such agents after providing consent.
9. Individuals with limitations in activities of daily living, including those who require the use of a cane.
10. Individuals with excessive alcohol intake.
11. Individuals who have previously been identified as having electrocardiographic abnormalities during health examinations.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 27 Day
Date of IRB - 2025 Year 11 Month 21 Day
Anticipated trial start date - 2025 Year 12 Month 03 Day
Last follow-up date - 2026 Year 04 Month 03 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068173
Disclaimer: Curated by HT Syndication.
