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A Study on the Long-term Efficacy of an Amino Acid Mixture in Healthy Adults: A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial

A Study on the Long-term Efficacy of an Amino Acid Mixture in Healthy Adults: A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial - A Study on the Long-term Efficacy of an Amino Acid Mixture in Healthy Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061148
Enrollment
150
Registered
2026-04-05
Start date
2026-04-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

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 sam

Sponsors

IMEQRD Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Aged 50 - 59 and meeting both AWGS2025 sarcopenia criteria: a. Grip strength: <34 kg (men), <20 kg (women) b. Limb muscle mass/height (BIA): <7.6 kg/m^2 (men), <5.7 kg/m^2 (women) Also applies to those aged 40 - 49 meeting these values 2. Regular use of medications affecting muscle or lipid metabolism 3. Unable to discontinue supplements/health foods (including amino acid preparations, FOSHU, or functional foods) 4. Unable to abstain from alcohol from one day before screening and each test 5. History or current drug/alcohol dependence 6. Participation in other food, drug, or topical studies within one month prior to consent, or planning to join other studies during this trial 7. Systolic BP >=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

Design outcomes

Primary

MeasureTime frame
High-dose group: Skeletal Muscle Index (SMI) Low-dose group: HbA1c

Secondary

MeasureTime frame
SMI (low-dose group only), HbA1c (high-dose group only), lower limb muscle mass, limb muscle mass, body fat percentage, balance, grip strength, fasting blood glucose, insulin, HOMA-IR, triglycerides (TG), free fatty acids (NEFA), POMS2 Short Form, SF-36

Countries

Japan

Contacts

Public ContactKayama Hirokuni

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026