Long-Term Safety Evaluation and Exploratory Assessment of Anti-Fatigue Effects of Continuous Intake of Food Containing Orotic Acid

Long-Term Safety Evaluation and Exploratory Assessment of Anti-Fatigue Effects of Continuous Intake of Food Containing Orotic Acid - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial - - Long-Term Safety Evaluation and Exploratory Assessment of Anti-Fatigue Effects of Continuous Intake of Food Containing Orotic Acid - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial -

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061228

Enrollment

Registered

2026-04-26

Start date

2026-06-11

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 will take one tablet of the test food daily, allowing it to dissolve in the mouth without chewing. Participants will take one tablet of the placebo food daily, allowing it to dissolve in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Aged 20 to under 65 2.Japanese men and women 3.BMI less than 30.0 kg/m^2 4.Able to enter electronic diaries via smartphone or PC 5.Fully informed about the study and voluntarily consented electronically

Exclusion criteria

Exclusion criteria: 1.Currently receiving treatment or medication (including Kampo) for any illness 2.Under dietary or exercise therapy supervised by a physician 3.Current or past serious illness 4.History of gastrointestinal surgery (except appendicitis) 5.Regular use of OTC drugs, quasi-drugs, health foods, supplements or foods with health claims; participation allowed if discontinued after consent 6.Current or past drug or food allergies 7.Habitual excessive alcohol intake (>=40g pure alcohol/day) 8.Habitual excessive smoking (>=21 cigarettes/day) 9.Shift workers with night shifts 10.Plans to significantly change lifestyle (diet, sleep, exercise, etc.) during the study 11.Plans for overseas travel during the study 12.Pregnant, breastfeeding, or planning pregnancy during the study 13.Participation in other clinical trials, within one month prior to consent, currently participating, or plans to participate during the study 14.Deemed unsuitable by the principal or sub-investigator

Design outcomes

Primary

Measure	Time frame
-Anthropometric measurements (weight, BMI) -Physiological assessments (blood pressure, pulse) -Blood tests (hematology, biochemistry) -Urinalysis -Incidence of adverse events and side effects	—

Secondary

Measure	Time frame
-POMS2 (Adult Short Version) -Fatigue Visual Analog Scale (VAS) -Multidimensional Fatigue Inventory (MFI)-20 (Japanese version) -Subjective experience questionnaire	—

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