Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061791) titled 'Effects of diosgenin intake and Karate exercises on physical fitness in healthy older adults
- Placebo-controlled, randomized, parallel-group comparative study-' on June 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - feileB Co., Ltd
Condition:
Condition - Healthy older adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of continuous diosgenin intake and regular Karate exercises on physical fitness improvement in healthy older male and female.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Test food intake with Karate exercises
Interventions/Control_2 - Test food intake without Karate exercises
Eligibility:
Age-lower limit - 65
years-old
Gender - Male and Female
Key inclusion criteria - 1) Male and female individuals aged 65 to 79 years.
2) Healthy individuals capable of maintaining a one-legged stance with eyes open for 10 seconds or longer.
3) Individuals with a Body Mass Index (BMI) of 18.5 to less than 30.0 kg/m2.
4) Individuals who have received a full explanation of the study's purpose and procedures and have provided written informed consent prior to participation.
Key exclusion criteria - 1) Individuals meeting the diagnostic criteria for sarcopenia (handgrip strength less than 26 kg for male or less than 18 kg for female, and a gait speed less than 0.8 m/sec)
2) Individuals with knee osteoarthritis or rheumatoid arthritis.
3) Individuals with a regular exercise habit of twice or more per week.
4) Individuals who have practiced Karate within the past 3 months.
5) Individuals who have received medical treatment for joint pain (such as in the knees or lower back) within 3 months prior to the start of the study.
6) Individuals who have sustained severe musculoskeletal injuries (e.g., fractures, tendon ruptures, or muscle strains) within the past year, or who find it difficult to perform physical exercise due to musculoskeletal pain or discomfort.
7) Individuals with a history of gastrointestinal surgery (excluding appendectomy).
8) Individuals with a current or past medical history of serious diseases (e.g., malignant tumors, cardiac disease, or neurological disorders).
9) Individuals who routinely consume health foods (e.g., Food for Specified Health Uses [FOSHU], dietary supplements, Foods with Function Claims) or calcium/vitamin D supplements that may affect the study parameters.
10) Individuals who are unable to discontinue the consumption of health foods (e.g., FOSHU, dietary supplements) from the time of informed consent until the completion of the study.
11) Heavy drinkers with an average pure alcohol intake of 60g per day or more
12) Individuals with extremely irregular dietary habits.
13) Shift workers or night-shift workers.
14) Individuals with a history of anaphylactic shock.
15) Individuals with an allergy to Japanese yam (Yamaimo).
16) Individuals who have participated in other clinical trials within 3 months prior to the date of informed consent, or who plan to participate in other clinical trials during the study period.
17) Individuals judged to be inappropriate for participation by the principal investigator.
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 16 Day
Date of IRB - 2026 Year 04 Month 23 Day
Anticipated trial start date - 2026 Year 06 Month 03 Day
Last follow-up date - 2026 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070538
Disclaimer: Curated by HT Syndication.
