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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054004
Enrollment
12
Registered
2024-04-09
Start date
2024-04-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Participants are to take, without chewing, four tablets of the research food after breakfast once a day for four weeks.

Sponsors

IMEQRD Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age: 20 to less than 65 years 2.Japanese males and females 3.Individuals with a BMI of less than 30.0kg/m^2 4.Capable of entering data via a smartphone or PC electronic diary 5.Individuals who have received adequate explanation regarding the trial, can comprehend its contents, and have produced written consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

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

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026