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Evaluation of the effect of a single intake of protein hydrolysate on metabolic indices in blood

Evaluation of the effect of a single intake of protein hydrolysate on blood metabolic indices in humans -Placebo-controlled, randomized, double-blind, crossover study- - Evaluation of the effect of a single intake of protein hydrolysate on blood metabolic indices in humans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046829
Enrollment
40
Registered
2022-02-06
Start date
2022-02-07
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 adult male and female

Interventions

Take 1 capsule containing protein hydrolysate per dose. Take 1 capsule without protein hydrolysate per dose. Take 5 capsule containing protein hydrolysate per dose. Take 5 capsule without protein hydr

Sponsors

SOUKEN Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy males and females from 20 to 60 years of age at the time of obtaining consent to participate in this study. 2) Subjects who feel daily fatigue. 3) Subjects who can input data into the electronic logbook using a PC, smartphone, etc. 4) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1) Subjects who have been diagnosed with or are undergoing treatment for mood disorders such as depression 2) Subjects who regularly use health foods such as supplements that claim to have effects on stress and mental health. 3) Subjects who consume a large amount of milk, dairy products, or milk-derived protein every day. 4) Subjects who have a habit of doing strenuous exercise. 5) Subjects who have an irregular life cycle 6) Subjects who may change their lifestyle such as a long trip, etc. 7) Subjects with gastrointestinal weakness, history of gastrointestinal problems, or current illness. 8) Subjects who drink a lot of alcohol. 9) Subjects who have a smoking habit. 10) Subjects who participated in a study involving the use other foods or medicines, or the application of cosmetics or medicines within one month prior to obtaining consent, or who will participate in another study while participating in this study. 11) Subjects who have donated 200 mL or more of blood (including whole blood and components) for 4 months before the start of the study. 12) Subjects who have experienced bad feeling or poor in physical condition due to blood collection in the past. 13) Subjects who may exhibit symptoms of allergy to milk or soy, or those who have a lactose intolerant constitution. 14) Subjects who are pregnant, or breast-feeding, or who planning to be pregnant during the study period. 15) Subjects with a history of serious hepatic, renal, or cardiac disease. 16) Subjects with a history or current illness of hepatitis, or severe anemia. 17) Subjects who are currently undergoing regular hospital visits and treatment for any kind of illness. 18) Subjects who are judged as unsuitable for the study because of the menstrual disorders or etc. by the investigators.

Design outcomes

Primary

MeasureTime frame
Plasma metabolism-related biomarkers

Secondary

MeasureTime frame
Fatigue-related questionnaire

Countries

Japan

Contacts

Public ContactRyo Uchida

Ajinomoto Co., Inc. Functional Ingredients Development Group, Wellness Value Creation Center, Institute of Food Sciences

ryo.uchida.xs6@asv.ajinomoto.com044-210-5844

Outcome results

None listed

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