Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060905) titled 'Evaluation of the Effects of Research Food on Bone and Joint Health' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kyushu Wimen's University
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The efficacy and safety of the research food for bones and joints will be evaluated by having healthy men and women consume it over time. This will involve measuring and assessing subjective symptoms related to joint pain, along with blood data such as joint markers and inflammation markers.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Test food intake (12 weeks)
Interventions/Control_2 - Placebo food intake (12 weeks)
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1) Healthy Japanese men and women aged 18 to 29 at the time of consent to participate in the trial.
2) Individuals not currently receiving medication for any medical condition.
3) Individuals able to consistently consume the test food throughout the trial period and strictly adhere to all precautions.
4) BMI between 20 and 27 inclusive.
5) Individuals able to submit dietary records (main staple foods and snacks for 3 days at the start and end of the trial).
6) Individuals deemed suitable for trial participation by the trial director and principal investigator.
Key exclusion criteria - 1) Individuals experiencing allergic symptoms such as hay fever and undergoing treatment
2) Individuals suffering from or with a history of severe cardiovascular disorders, hepatic dysfunction, renal dysfunction, respiratory disorders, endocrine disorders, or metabolic disorders
3) Individuals with a history of severe disease requiring ongoing medication
4) Individuals at risk of developing allergies related to the trial
5) Individuals participating in another clinical trial at the start of this trial, or who have participated in one within the past month.
6) Individuals who are pregnant, breastfeeding, or plan to become pregnant during the trial period.
7) Other individuals deemed unsuitable as subjects by the trial investigator.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 28 Day
Date of IRB - 2026 Year 03 Month 12 Day
Anticipated trial start date - 2026 Year 04 Month 20 Day
Last follow-up date - 2026 Year 09 Month 04 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069697
Disclaimer: Curated by HT Syndication.
