Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058314) titled 'A study for validation of muscular strength effects by beverages containing lactic acid bacteria in elderly individuals' on June 30.
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 obtain data that clarifies the suppressive effect of test-food intake on grip strength decline and to elucidate its underlying mechanisms.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral consumption of the test food (1 bottle, once daily) for 24 weeks
Interventions/Control_2 - Oral consumption of the placebo food (1 bottle, once daily) for 24 weeks
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Male and female aged 65 years or older at the time of consent acquisition.
2. Individuals with self-perceived physical decline.
3. 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 heavy lifting or other physically demanding work.
2. Individuals with irregular working hours, such as day-night shift.
3. Individuals who have suffered injuries affecting physical mobility, such as fractures or tendon ruptures, within the past year.
4. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims (e.g., those containing lactic acid bacteria, or those claiming to alleviate fatigue), or health foods (including supplements) that may affect the outcomes of the trial, and who are unable to discontinue their use after providing informed consent.
5. Individuals who take supplements containing vitamin D, amino acids, or unsaturated fatty acids (DHA/EPA) regularly within the past three months and unable to discontinue.
6. Individuals who take drugs and quasi-drugs (e.g., nutritional supplements for fatigue, vitality, dementia medications, lactic acid bacteria preparations, gastrointestinal medications, antibiotics) regularly that may affect the outcomes of the trial, and are unable to discontinue their use.
7. Individuals who take steroids or hormones (e.g., compounds containing androgen or estrogen) within the last three months that may affect the outcomes of the trial, and are unable to discontinue their use.
8. Individuals with walking impairment in daily life, such as using cane.
9. Individuals with excessive alcohol intake.
10. Individuals with previous and/or current medical history of serious diseases in the severe cardiac, hepatic, renal, digestive, diabetes, rheumatoid arthritis and osteoarthritis.
11. Individuals with allergies to medications or food (particularly those with allergies to milk or soy).
12 Individuals with self-reported lactose intolerance.
13. Individuals who are participating in or have participated in a trial of pharmaceuticals or health foods within the four weeks prior to the current trial.
Target Size - 140
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 23 Day
Date of IRB - 2025 Year 06 Month 20 Day
Anticipated trial start date - 2025 Year 07 Month 01 Day
Last follow-up date - 2026 Year 04 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066499
Disclaimer: Curated by HT Syndication.
