Tokyo, April 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061148) titled 'A Study on the Long-term Efficacy of an Amino Acid Mixture in Healthy Adults: A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial' on April 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The study is aimed to evaluate the effects of 12-week intake of an amino acid mixture on physical and metabolic functions in healthy adults who report insufficient physical activity.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will consume two sachets daily (test-food-2 and one control-food-1) for 12 weeks and perform specified resistance exercises and walking at designated frequency and duration during the same period.
Interventions/Control_2 - Participants will consume two sachets daily (test-food-1 and one control-food-2) for 12 weeks and perform specified resistance exercises and walking at designated frequency and duration during the same period.
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1. Healthy adults aged 40 to under 60 at consent
2. Self-reported insufficient physical activity
3. Predominantly sedentary lifestyle (e.g., remote work)
4. Tendency to accumulate fat in the lower body
5. feeling physical fatigue frequently
6. Able to enter electronic diaries via PC or smartphone
7. Fully informed, capable of consent, and voluntarily agree in writing to participate
Key exclusion criteria - 1. Aged 50 - 59 and meeting both AWGS2025 sarcopenia criteria:
a. Grip strength: =160 mmHg or diastolic BP >=100 mmHg at screening
8. Serious renal, gastrointestinal, cardiac, respiratory, endocrine, or metabolic diseases, or under treatment
9. Physical disabilities (e.g., back/knee pain) interfering with exercise
10. Orthopedic surgery affecting exercise (e.g., back, knee)
11. Implanted pacemaker or metal devices
12. Prohibited from exercise by a physician
13. History of vasovagal syncope
14. Currently receiving treatment for any disease (as-needed medication permitted)
15. Current or past food/drug allergies
16. Excessive alcohol consumption (>=40g pure alcohol/day)
17. Heavy smoking (>=21 cigarettes/day)
18. Shift workers with night shifts
19. Plans for major lifestyle changes (e.g., long trips) during the study
20. Deemed ineligible by the principal investigator
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 23 Day
Date of IRB - 2026 Year 02 Month 02 Day
Anticipated trial start date - 2026 Year 04 Month 06 Day
Last follow-up date - 2026 Year 08 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069972
Disclaimer: Curated by HT Syndication.
