Healthy subjects
Conditions
Interventions
Continuous ingestion of the test food for 3 weeks washout Continuous ingestion of the placebo food for 3 weeks
Continuous ingestion of the placebo food for 3 weeks washout Continuous ingestion of
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Japanese males who are aged 35 years or older and younger than 65 years at the time of written informed consent. 2.Subjects whose BMI is 21 kg/m2 or more and less than 30 kg/m2. 3.Subjects whose LDL-Cho level is 100 mg/dL or more and less than 140 mg/dL. 4.Non-smokers. 5.Subjects whose mean alcohol consumption of less than 30 g per day. 6.Subjects who are fully informed of the purpose and details of the study, capable of giving informed consent, and volunteering to participate in the study based on a full understanding of it, and who have given written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects receiving medication or outpatient treatment for a serious disease. 2.Subjects receiving exercise or diet therapy under the supervision of a physician. 3.Subjects who may be allergic to any of the raw materials of the study food or other foods evaluated in the study (wheat, milk components, soybean, chicken, or pork). 4.Subjects with current or previous history of drug dependence or alcohol dependence. 5.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder. 6.Night or shift workers with irregular life patterns. 7.Subjects doing physical work for 10 hours or more per week. 8.Subjects whose eating, sleeping, and other habits are extremely irregular. 9.Subjects who are having a very unbalanced diet. 10.Subjects doing exercise to maintain or improve strength for 30 minutes or more twice a week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MDA-LDL | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) LDL-Cho,LP-PLA2,sd-LDL,PAO,Stool examination (fecal microbiome), stool questionnaire parameters (e.g., frequency, characteristics, and amount of stool) (Safety endpoints) Vital signs, physical measurements (body weight and BMI), adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed