None listed
Conditions
Interventions
Oral intake of test meal A (4 times in a day [eating for breakfast, lunch, dinner, and snacks
4 weeks.).
Oral intake of normal meals (keeping habit of eating before participating with the study
4 weeks).
Sponsors
NISSIN FOOD PRODUCTS CO., LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1] Healthy Japanese males aged 30-64 years. [2] Individuals whose visceral fat area is over 100cm2. [3] Individuals who do not have a habit of drinking. [4] Individuals whose written informed consent has been obtained. [5] Individuals who can visit an inspection facility and be inspected in designated days. [6] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals who cannot continue to eat a test meal for 4 weeks. [2] Individuals whose eating habit for breakfast, lunch, and dinner is irregular and has an unbalanced diet. [3] Individuals who are in constipation. [4] Individuals using medical products. [5] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [6] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [7] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [8] Individuals who contract or have a history of serious endocrine disease. [9] Individuals with metal in their body that cannot be removed. Individuals with a cardiac pacemaker. [10] Individuals who recorded weight gain and loss (+-2 kg) in the past 1 month. [11] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [12] Individuals who are sensitive to test product or other foods, and medical products. [13] Individuals who are undergoing dietary therapy [14] Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [15] Individuals who have or had a habit to ingest health-promoting foods, foods for specified health uses, or health foods in the past 3 months, or will ingest those foods during the test period. [16] Individuals who have difficulty conducting tests using mobile applications. [17] Individuals who are unable to properly store or consume the test foods due to reasons such as inability of setting the distributed freezer or non-possession of a microwave oven. [18] Individuals who participated in other clinical studies in the past 3 months. [19] Individuals who are or whose family is engaged in health foods of functional foods. [20] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1] Indexes for visceral fat area and genetic analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Specific fecal test [2] Specific blood test [3] Indexes for body composition. [4] Physical and clinical examinations. [5] Measurement of subcutaneous fat area by FatScan using CT scan images. [6] Food frequency questionnaire:FFQ *Safety [1] Doctor's questions [2] Side effects and adverse events [3] Subject's diary *Other indexes [1] Evaluation of visceral fat mass area by impedance method. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed