Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058815) titled 'The effects of test foods containing DHA and vitamin D on bone in healthy participants' on March 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Fuji Oil Co., Ltd.
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the effects of consuming test foods containing DHA and vitamin D on bone metabolites in healthy women.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Consumption of test foods
(4 weeks each in summer and winter)
Interventions/Control_2 - Consumption of test foods
(4 weeks each in summer and winter)
Eligibility:
Age-lower limit - 18
years-old
Gender - Female
Key inclusion criteria - 1) Directly employed by Fuji Oil Co., Ltd. and able to visit the health management office on the day of blood sampling
2) Written consent for participation in the study has been obtained from the participant
3) Able to communicate in Japanese
Key exclusion criteria - 1)Individuals currently taking DHA or EPA
2)Individuals currently taking vitamin D
3)Individuals who regularly consume vitamin D-fortified foods (e.g., egg yolks)
4)Individuals using medications containing vitamin D due to skin conditions
5)Individuals currently receiving medication for osteoporosis prescribed by a physician
6)Individuals who have experienced abnormal symptoms such as feeling unwell or a drop in blood pressure during or after blood collection.
7)Other individuals deemed ineligible for this study by an occupational physician.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Date of IRB - 2025 Year 07 Month 02 Day
Anticipated trial start date - 2025 Year 08 Month 22 Day
Last follow-up date - 2026 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067259
Disclaimer: Curated by HT Syndication.