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The study to evaluate the effect of the test food on fatigue due to exercise

The study to evaluate the effect of the test food on fatigue due to exercise: a randomized, placebo-controlled, double-blind, parallel group study - The study to evaluate the effect of the test food on fatigue due to exercise: a randomized, placebo-controlled, double-blind, parallel group study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056563
Enrollment
52
Registered
2025-01-06
Start date
2025-01-06
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 subjects

Interventions

Subjects receive the test foods for 4 weeks Subjects receive placebo for 4 weeks

Sponsors

EZAKI GLICO Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males and females between the ages of 25 and 44 who have an exercise habit 2) Subjects who agree to the study

Exclusion criteria

Exclusion criteria: 1) Subjects who are unable to refrain from taking health foods, including dietary supplements, or quasi-drugs and over-the-counter drugs that are taken orally that could affect the study. 2) Subjects who habitually take the test food. 3) Subjects who are unable to abstain from smoking. 4) Subjects whose BMI are 25.0 kg/m^2 or more. 5) Subjects who have under treatment or a history of serious disease such as diabetes mellitus, liver disease, renal disease, cardiac disease, circulatory system disease, etc. 6) Subjects who have a disease under treatment or have a pre-existing serious disease that required medication. 7) Subjects who may develop allergic symptoms to the test food or who may develop severe allergic symptoms to the default food to be distributed. 8) Pregnant or planning to become pregnant during the study, and lactating mothers. 9) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies. 10) Subjects who are likely to change their lifestyle, including diet and exercise, during the study. 11) Subjects who fall under the category of menstrual irregularities. 12) Subjects who are judged as unsuitable for the study by principal investigator.

Design outcomes

Primary

MeasureTime frame
Fatigue VAS (visual analog scale)

Secondary

MeasureTime frame
Endurance performance POMS2 (Profile of Mood States second edition) Sleep-quality questionnaire Blood BAP, dROMs, IL6, and glutathione Urinary 8-OHdG and biopyrrins

Countries

Japan

Contacts

Public ContactYuki Urushizawa

EUPHORIA Co., Ltd. Data Management Department

yuki.urushizawa@eu-phoria.jp+81-3-6388-9260

Outcome results

None listed

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