Tokyo, April 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061180) titled 'A systematic review of the effects of Lactococcus lactis subsp. cremoris H61 (heat-killed) on supporting iron supplementation' on April 20.
Study Type:
Others,meta-analysis etc
Primary Sponsor:
Institute - Japan Clinical Trial Association
Condition:
Condition - Healthy adults (generally aged 18 years or older) without apparent iron-deficiency anemia or chronic diseases
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To systematically evaluate whether continuous intake of Lactococcus lactis H61 improves iron absorption or iron status in healthy individuals compared with no intake or placebo.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Participants
Healthy adults (generally aged 18 years or older) without apparent iron-deficiency anemia or chronic diseases
Interventions
Continuous intake of Lactococcus lactis subsp. cremoris H61 (heat-killed)
Comparators
Placebo or no intake
Outcomes
Primary outcome:
Serum ferritin
Secondary outcomes:
Serum iron, transferrin saturation (TSAT), hemoglobin, and other iron metabolism-related parameters
If direct indicators of iron absorption, such as those measured using stable isotope techniques, are reported, they will also be evaluated.
Study design
Randomized controlled trials (RCTs) and non-randomized intervention studies
Key exclusion criteria - Animal studies, in vitro studies, studies including only patients with specific diseases, studies using lactic acid bacteria other than H61 alone, and studies that did not report iron-related outcomes
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 06 Day
Anticipated trial start date - 2026 Year 04 Month 07 Day
Last follow-up date - 2027 Year 04 Month 07 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070000
Disclaimer: Curated by HT Syndication.
