A placebo controlled, double blind, comparative trial concerning safety verification of long-term intake of protein hydrolyzate
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000052861
- Lead Sponsor
- IMEQRD Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Body Weight, BMI, Body fat percentage -Blood pressure, Pulse -Hematology test -Blood biochemical test -General urine test -Adverse event
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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