Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061516) titled 'Effects of Plant Protein on Health Functions' on May 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 - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine whether plant protein exhibits its health-promoting effects when ingested in a confectionery format.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Crunchy chocolate containing plant protein
Interventions/Control_2 - Crunchy chocolate containing whey protein isolate
Eligibility:
Age-lower limit - 18
years-old
Gender - Male
Key inclusion criteria - 1)Employees directly employed by Fuji Oil Co., Ltd. who are able to visit the health management office on the scheduled blood sampling day.
2)Individuals who have provided written informed consent to participate in the study.
3)Individuals who are able to communicate in Japanese.
Key exclusion criteria - 1)Individuals receiving pharmacological treatment for diabetes mellitus or dyslipidemia
(those receiving only dietary and/or exercise therapy are eligible).
2)Individuals who have experienced abnormal symptoms such as feeling unwell or a drop in blood pressure during or after blood collection
3)Individuals with food allergies, including allergy to soybeans, birch pollen, cocoa, etc.
4)Other individuals deemed ineligible for this study by an occupational physician
Target Size - 30
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2023 Year 11 Month 28 Day
Date of IRB - 2023 Year 11 Month 28 Day
Anticipated trial start date - 2024 Year 01 Month 17 Day
Last follow-up date - 2027 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070396
Disclaimer: Curated by HT Syndication.