Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055492) titled 'Study of the test-food consumption on bone metabolism in women' 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 - Univ.Tsukuba
Condition:
Condition - non
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To determine the eff ects of ingestion of the test food on bone in women
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - intake of test-food (12W or 24W)
Interventions/Control_2 - pracebo intake(12W or 24W)
Eligibility:
Age-lower limit - 18
years-old
Gender - Female
Key inclusion criteria - women
Key exclusion criteria - Those who have been diagnosed with osteoporosis by a physician
Those who have an extremely irregular lifestyle in terms of eating, sleeping, etc.
Those who have an extremely picky eater.
Those who use or are unable to refrain from using medicines, health foods, supplements, etc. (calcium, vitamin D, etc.) that affect bone function.
Persons who regularly use medicines, health foods, supplements, etc. that contain or are fortified with foods high in calcium.
Persons who have donated more than 200 mL of blood within one month or more than 400 mL within three months of the date of consent.
Those who are currently pregnant or lactating, or who may become pregnant or lactating during the study period.
Persons who have difficulty in complying with the recording of various questionnaires
Persons who are judged to be unsuitable as research subjects based on clinical laboratory values or measurements at the time of Pre measurement.
Those who have already been exposed to 1 mSv or more of X-rays within the past year.
Other subjects who are deemed inappropriate as research subjects by the physician in charge of the research.
Target Size - 30
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 07 Month 01 Day
Date of IRB - 2024 Year 08 Month 29 Day
Anticipated trial start date - 2024 Year 09 Month 16 Day
Last follow-up date - 2025 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063406
Disclaimer: Curated by HT Syndication.
