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A placebo controlled, double blind, comparative trial concerning safety verification of long-term intake of protein hydrolyzate

A placebo controlled, double blind, comparative trial concerning safety verification of long-term intake of protein hydrolyzate - A placebo controlled, double blind, comparative trial concerning safety verification of long-term intake of protein hydrolyzate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052861
Enrollment
30
Registered
2023-12-12
Start date
2023-12-13
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

Take 4 capsules test food between meals per day with water. Take 4 capsules placebo food between meals per day with water.

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy male and female aged 20 years or older on the date of consent acquisition. 2. Individuals able to input electronic diaries via PCs, smartphones etc. 3. Individuals who have received a sufficient explanation of the purpose and content of the trial, have the capacity to consent, have a good understanding, voluntarily wish to participate, and have consented in writing to participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Individuals currently taking commercial pharmaceuticals and quasi-drugs, health foods and supplements aimed at maintaining and recovering health, and unable to discontinue use during the trial period. 2. Individuals who have participated in experiments consuming other foods or using pharmaceuticals, applying cosmetics and pharmaceuticals etc. within one month from the day of consent, or intends to participate in other trials during this trial. 3. Individuals who consume large amounts of alcohol (equivalent to 40 g or more of alcohol per day). 4. Individuals with irregular lifestyles such as shift work, night work, etc. 5. Individuals with smoking habits (those who are less than one year after quitting). 6. Individuals planning major lifestyle changes (diet, sleep, exercise habits etc.) during the trial period, such as long trips. 7. Individuals who consume large amounts of milk, dairy products, or protein foods derived from milk every day (for example, over 1 L / day of milk, over 500 g / day of yogurt, or over 20 g / day of protein foods). 8. Individuals who have undergone gastrointestinal surgery, however, appendectomy is acceptable. 9. Individuals currently under treatment with any medications or Chinese medicines, however, instant use is acceptable. 10. Individuals with serious liver, kidney, heart, respiratory, endocrine, metabolic diseases, mental illnesses, or higher brain dysfunction. 11. Individuals with a history of treatment for heart failure, myocardial infarction, etc. 12. Individuals who have experienced discomfort or health deterioration, or vasovagal reflex due to blood collection. 13. Individuals likely to show symptoms of milk/soy allergy, or who have lactose intolerance. 14. Individuals with a current or history of drug or food allergies. 15. Individuals currently pregnant or breastfeeding, or wishing to become pregnant during the trial period. 16. Individuals deemed inappropriate as research subjects by the study's principal investigator.

Design outcomes

Primary

MeasureTime frame
-Body Weight, BMI, Body fat percentage -Blood pressure, Pulse -Hematology test -Blood biochemical test -General urine test -Adverse event

Countries

Japan

Contacts

Public ContactHirokuni Kayama

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