None listed
Conditions
Interventions
Sponsors
NISSIN FOOD PRODUCTS CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males and females aged 30-64 years. [2] Individuals whose BMI is more than 23.0 kg 2 and less than 30.0 Kg 2. [3] Individuals who consume alcohol regularly in terms of frequency and quantity, and have a habit of daily consuming about 20 g/day of pure alcohol equivalent. [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 with arrhythmias including atrial fibrillation. [7] Individuals with a history of syncope. [8] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [9] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [10] Individuals who contract or have a history of serious endocrine disease. [11] Individuals with metal in their body that cannot be removed. Individuals with a cardiac pacemaker. [12] Individuals who recorded weight gain and loss (+-2 kg) in the past 1 month. [13] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [14] Individuals who are sensitive to test product or other foods, and medical products. [15] Individuals who are undergoing dietary therapy [16] Individuals who are allergic to metals or who are at risk of developing allergies to metals [17] Individuals with possible changes of lifestyle, such as conducting a long-term travel, during the test period. [18] 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. [19] Individuals who are or are possibly pregnant, or are lactating. [20] Individuals who participated in other clinical studies in the past 3 months. [21] Individuals who are or whose family is engaged in health foods of functional foods. [22] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for biological rhythm and visceral fat (biological rhythm, stress, sleep, FatScan visceral fat area using CT scan images). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Indexes for body composition. [2] Physical and clinical examinations. [3] Specific blood test [4] Specific fecal test [5] Specific urinary test [6] Measurement of subcutaneous fat area by FatScan using CT scan images. [7] Heart rate variability test under orthostatic load. [8] Blood glucose measurement with Free Style Libre. [9] Food frequency questionnaire:FFQ [10] State-Trait Anxiety Inventory-JYZ [11] The Japanese version of the Pittsburgh Sleep Quality Index. *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