Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062214) titled 'Effect of Sun-Dried Dried Squid Products (Sakiika) on Vitamin D Status' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Kobe Gakuin University
Condition:
Condition - Vitamin D deficiency and insufficiency
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The primary objective of this study is to determine whether sun-dried sakiika (dried squid) can improve vitamin D status in individuals with vitamin D deficiency or insufficiency and thereby serve as a practical dietary option for improving vitamin D nutritional status. In addition, this study aims to evaluate whether urinary 25-hydroxyvitamin D [25(OH)D] concentration, measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS), can be used as a biomarker of vitamin D nutritional status in addition to the conventional assessment based on serum 25(OH)D concentration.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention group: Participants will consume sun-dried sakiika (dried squid) four times per week for 4 weeks.
Interventions/Control_2 - Control group: Participants will consume sakiika (dried squid) that has not been sun-dried four times per week for 4 weeks.
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - Healthy women in their 20s and 30s who provide written informed consent to participate in this study at Kobe Gakuin University.
Key exclusion criteria - Individuals with a past or current history of severe hepatic or renal disease, autoimmune disease, diabetes mellitus, dyslipidemia, metabolic syndrome, hypolipidemia, thyroid disease, bone metabolic disorders, or any other condition requiring medical treatment, as well as those taking dietary supplements, will be excluded from the study.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 08 Day
Date of IRB - 2026 Year 07 Month 08 Day
Anticipated trial start date - 2026 Year 08 Month 31 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071187
Disclaimer: Curated by HT Syndication.