Healthy subjects
Conditions
Interventions
Daily ingestion of the test food 1 for 12 weeks
Daily ingestion of the test food 2 for 12 weeks
Daily ingestion of the placebo food for 12 weeks
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are aged 20 to under 65 years at the time of written informed consent. 2.Subjects whose BMI is less than 30 kg/m2. 3.Subjects who are aware of their sensitivity to cold. 4.Non-smokers. 5.Subjects whose mean alcohol consumption of less than 30 g per day (as an average of one week). 6.Subjects who have been fully informed the purpose and details of the study, have the ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
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 maybe for allergic reactions to the material of the test food (dietary ingredients). 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.Subjects with a large wound or inflammation at the site of measurement (hand or arm) that may interfere with device measurement or evaluation 7.Subjects with excessively thick body hair or a tattoo at the site of measurement (hand or arm) that may interfere with device measurement or evaluation. 8.Subjects with symptoms of photosensitivity, ultraviolet allergy, or related conditions. 9.Night or shift workers with extremely irregular life patterns. 10.Subjects doing physical work for 10 hours or more per week. 11.Subjects whose eating, sleeping, and other habits are extremely irregular. 12.Subjects who are having a very unbalanced diet. 13.Subjects doing exercise to maintain or improve strength for 30 minutes or more twice a week. 14.Subjects whose body weight increased or decreased by 5 kg or more in the last 2 months. 15.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases. 16.Subjects who routinely consume health foods, supplements, and medications that affect vascular function. 17.Subjects who take products that impact antioxidant capacity such as health foods, supplements, and drugs (e.g., vitamins E and C, astaxanthin, beta-carotene, sesamin) three or more days a week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cold sensitivity | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Vascular endothelial function (flow-mediated vasodilation), questionnaire on eye and nasal symptoms (Japanese Allergic Conjunctival Disease Standard Quality of Life Questionnaire), blood fatty acid concentrations, blood lipid levels, blood metabolites, genomic information on single nucleotide polymorphisms (SNPs) (Safety evaluation) Vital signs, physical measurements (body weight and BMI), blood biochemical examination, hematologic test, adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed