Excessive Intake Safety Test of the Research Food -Single Arm Open Label Trial-

UMIN ID: UMIN000054004

Registered date:09/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/04/10
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Participants are to take, without chewing, four tablets of the research food after breakfast once a day for four weeks.

Outcome(s)

• Primary Outcome: -Physical examination (weight, BMI, blood pressure, pulse) -Blood test items (hematological examination, biochemical blood test) -Urinalysis -Incidence of adverse events and side effects

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1.Currently undergoing pharmacological treatment (except for on-demand medicines) 2.Currently under dietary or exercise therapy supervised by a physician 3.Individuals with a current or past history of serious disease 4.Those aware of their propensity to develop diarrhea 5.Individuals with surgical history on the digestive tract (appendicitis is acceptable) 6.Individuals with current or past food or drug allergies 7.Habitual heavy drinkers (benchmark: daily pure alcohol consumption exceeding 40g) 8.Heavy smokers (benchmark: over 21 cigarettes per day) 9.Individuals who work night shifts in rotating shifts 10.Those planning major lifestyle changes (diet, sleep, exercise habits, etc.) during the test period, such as long trips 11.Currently pregnant or breastfeeding individuals, or those hoping to get pregnant during the trial period 12.Past occurrences of vasovagal reaction or felt unwell immediately after blood collection 13.Participants in other clinical trials of drugs or health foods, within four weeks post-trial, or planning to participate in other clinical trials after consent to participate in this trial 14.Those who performed blood donation or plasma donation within three months before the start of the trial 15.Individuals deemed unsuitable for the trial by the principal investigator or co-principal investigator

Related Information

• Primary Sponsor: IMEQRD Co. Ltd.
• Source(s) of Monetary Support: KINS Co,.Ltd.