Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063221) titled 'A prospective observational study on the effects of D-alanine intake on amino acid metabolism in adult women' on Oct. 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - SHOWA WOMEN'S UNIVERSITY
Condition:
Condition - Age-related diseases
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of D-alanine intake on amino acid metabolism in healthy adult women.
Basic objectives2 - Pharmacokinetics
Intervention:
Interventions/Control_1 - Orally ingest 2 g of the test food (containing 1 g of D-alanine) daily for 8 weeks.
Interventions/Control_2 - Orally ingest 2 g of placebo (maltodextrin) daily for 8 weeks
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - Eligibility is limited to individuals who meet all of the following criteria:
1) Individuals who are 18 years of age or older at the time consent is obtained
2) Individuals who provide written consent to participate in this study
Key exclusion criteria - Those who meet any of the folowing criteria wil be excluded.
1) Those who are currently visiting a hospital and taking medication
2) Those who are deemed inappropriate to be subjects by the principal investigator
Target Size - 30
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 09 Month 03 Day
Date of IRB - 2026 Year 09 Month 16 Day
Anticipated trial start date - 2026 Year 10 Month 10 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=R000072361
Disclaimer: Curated by HT Syndication.
