Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061437) titled 'A study to evaluate the safety of excessive consumption of the test food' on May 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Amino Up Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the safety of excessive consumption of the test food.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Oligonol1 g/day,10 cupsiles/day,4 weeks
Interventions/Control_2 - Placebo (Dextrin), 10 capsules/day for 4 weeks
Eligibility:
Age-lower limit - 25
years-old
Gender - Male and Female
Key inclusion criteria - 1.Individuals with a BMI of 22.0 kg/m2 or higher but less than 30.0 kg/m2
2.Men and women aged 25 to 64
3.Individuals who have provided written consent to participate in this study
Key exclusion criteria - 1.Individuals for whom participation in the trial is difficult due to liver, kidney, or heart disease; respiratory disorders; endocrine disorders; metabolic disorders; neurological disorders; impaired consciousness; diabetes; or other medical conditions
2.Individuals who have undergone surgery or received medication for an illness or injury within two months prior to the start of this trial
3.Individuals currently taking medications to improve glucose metabolism, lipid metabolism, or blood pressure
4.Individuals who regularly consume foods for specific health uses or foods with functional claims (however, this does not apply to those who can suspend consumption during the trial period at the time of obtaining the consent form)
5.Individuals who are unable to consume the test food
6.Individuals who may exhibit allergic reactions to ingredients contained in the test food
7.Individuals currently participating in another clinical trial or planning to participate in one during the duration of this trial
8.Individuals who do not agree with the purpose of this trial as explained in the pre-trial briefing
9.Individuals who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the trial period
10.Any other individuals whom the principal investigator deems unsuitable from the perspective of ensuring subject safety, based on data from health examinations or other sources
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 10 Day
Date of IRB - 2026 Year 03 Month 19 Day
Anticipated trial start date - 2026 Year 05 Month 07 Day
Last follow-up date - 2026 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070297
Disclaimer: Curated by HT Syndication.
