Tokyo, April 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061066) titled 'Essential Amino Acid Study' on April 13.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Ritsumeikan University
Condition:
Condition - Not applicable: Healthy women volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of long-term essential amino acid intake on muscle mass gain.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Use the essential amino acid mixture (manufactured by Toyo Shinyaku).The study will be conducted as a crossover trial, with participants taking 8 g of powder containing 3.0 g of essential amino acids after training on training days and after breakfast on other days (once daily for a total of 12 weeks).
Interventions/Control_2 - Whey protein (manufactured by Sankyo Food Industries) will be used. Participants will consume 14.6 g of whey protein (containing 9.0 g of protein) after training on days when they train, and after breakfast on other days (once daily for a total of 12 weeks), in a crossover design.
Eligibility:
Age-lower limit - 50
years-old
=
Gender - Female
Key inclusion criteria - Healthy women aged between 50 and 75.
Participants who have been assessed by the principal investigator or a co-investigator and found to be in good health.
Participants who have received a full explanation of the studys objectives and methods and have provided written consent.
Key exclusion criteria - Those who regularly undertake resistance training.
Those who regularly consume amino acids or protein supplements.
Those with an allergy to milk or soya contained in the test food.
Those with orthopaedic conditions affecting the upper or lower limbs.
Those with a low body fat percentage (less than 20%).
Any other individuals deemed unsuitable by the medical director (doctor).
Target Size - 60
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 01 Month 20 Day
Date of IRB - 2026 Year 02 Month 26 Day
Anticipated trial start date - 2026 Year 03 Month 26 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069766
Disclaimer: Curated by HT Syndication.