None listed
Conditions
Interventions
Intake of the test meal (1 time in a day
4 weeks).
Intake of normal meals (keeping habit of eating before participating with the study
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males and females aged 20-64 years. [2] Individuals whose daily salt intake is higher than the target value for salt equivalent in the Dietary Reference Intakes for Japanese (7.5g/day for male and 6.5g/day for female). [3]Individuals who have a habit of eating three meals a day (breakfast, lunch and dinner). [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 have difficulty in carrying out the specified items for the 4 weeks of the test period. [2]Individuals using medical products. [3]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [5]Individuals who are a patient or have a history of or endocrine disease. [6]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [7]Individuals whose BMI is over 30kg/m2. [8] Individuals who donated blood within the last 4 weeks to the current study. [9]Individuals who experienced unpleasant feeling during blood drawing. [10] Individuals who have or may have food allergies. [11]Individuals who are unbalanced in their daily diet (picky eaters). [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [13]Individuals who smoke more than 21 cigarettes per day on a daily basis. [14]Individuals who have a habit to use health-promoting foods, foods for specified health uses, or health foods claiming to reduce Visceral fat or body fat in the past 3 months. [15]Individuals with possible changes of life style during the test period. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes for salt consumption. (From the morning after the Week 0 until the last day of the study.) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Taste survey on saltiness with Visual Analog Scale (VAS).(1) [2]Indexes for body composition / visceral fat mass. (2) [3]Blood special test. (2) [4]Urine special test. (1) [5]Skin Age measurement. (2) [6]Indexes for QOL. (2) [7]Blood glucose measurement with Free Style Libre. (3) [8]Physical and clinical examinations. (2) (1):Week 0 and Week 4 (2):Week 0, Week 2 and Week 4 (3):Every day from Week 0 to the last day of the study. *Safety [1] Doctor's questions.( Week 0, Week 2 and Week 4) [2] Side effects/ Adverse events.(Week 2 and Week 4) *Other indexes [1] Subject's diary (From the first day of ingestion of a test material to the last day of the test). [2] Dietary survey (7 days prior to the test date). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed