Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061495) titled 'Clinical Study for the Evaluation of the Effects of Test Food Consumption on Walking Function' on May 11.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - EP Mediate Co., Ltd.
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Placebo-controlled evaluation of 12-week test food intake on walking function and safety.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - One packet of the test food daily for 12 weeks
Interventions/Control_2 - One packet of placebo food daily for 12 weeks
Eligibility:
Age-lower limit - 50
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Healthy men and women aged 50 to 75 years
(2) Subjects with age-related declines in walking ability
(3) Person who can understand the purpose and content of this study and agree in this study
Key exclusion criteria - (1) Subjects with diseases that may affect the study evaluation, or a history of such conditions
(2) Subjects who experience severe knee or lower-back pain that interferes with daily activities or walking
(3) Subjects who continuously consume health foods related to joints or muscles
(4) Subjects who engage in strenuous exercise that places stress on the joints
(5) Subjects who regularly engage in activities that may affect the evaluation of efficacy
(6) Subjects who may develop allergies in relation to the study
(7) Subjects with conditions requiring continuous medication those currently under treatment , or those with a history of serious illnesses requiring pharmacological treatment
(8) Subjects with serious neurological diseases, malignant tumors, diabetes, liver, kidney, or heart diseases, or a history of such conditions
(9) Subjects with current or past psychiatric disorders, or those strongly suspected of having such conditions
(10) Subjects with markedly abnormal anthropometric, physical, or clinical test values prior to intake
(11) Subjects with irregular lifestyles such as shift work or night work
(12) Subjects with participation in another clinical study within the past month
(13) Subjects who plan to become pregnant or breastfeed during the study period
(14) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey
(15) Subjects who are judged as unsuitable for the study by the principal investigator or the investigator for other reason
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 23 Day
Date of IRB - 2026 Year 04 Month 23 Day
Anticipated trial start date - 2026 Year 05 Month 11 Day
Last follow-up date - 2026 Year 10 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070361
Disclaimer: Curated by HT Syndication.
