None listed
Conditions
Interventions
Oral intake of the test product (Any one meal of breakfast, lunch or dinner
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
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged 20-59 years 2) Individuals who experience stress and fatigue in their daily lives, or who are prone to feeling stress and fatigue (ex. stress and fatigue due to work, housework). 3) Individuals who are dissatisfied with their sleep quality. 4) Individuals who sleep alone. 5) Individuals who work 5 days a week during the day and have Saturdays and Sundays off. 6) Individuals who have a regular lifestyle on weekdays (ex. wake-up time or bedtime). 7) Individuals whose written informed consent has been obtained. 8) Individuals who can come to the designated venue for this study and be inspected. 9) Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: 1) Individuals using medical products. 2) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes and hyperlipidemia. 3) Individuals who have or have a history of sleep apnea syndrome (SAS) 4) Individuals whose BMI is over 25.0kg/m2. 5) Individuals who used a drug to treat a disease in the past 1 month. 6) Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease and hematological disease. 7) Individuals who are a patient or have a history of or gastrointestinal disease. 8) Individuals who have or may have food allergic symptoms. 9) Individuals who cannot continue to eat a test meal 10) Individuals whose eating habit for breakfast, lunch, and dinner is irregular and has an unbalanced diet. 11) Individuals who have frequent alcohol intake habits (individuals who have difficulty abstaining from alcohol during the home survey period). 12) Individuals who have an environment that disturbs sleep at bedtime (ex. infants or pets). 13) Individuals with possible changes of lifestyle, such as conducting a long-term travel, during the test period. 14) Individuals whose sleeping conditions may be different during the period of electroencephalogram measurement (ex. overnight stay). 15) Individuals who are or are possibly pregnant, or are lactating. 16) 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. 17) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 18) Individuals who have difficulty conducting tests using mobile applications. 19) Individuals who participated in other clinical studies in the past 3 months. 20) Individuals who are or whose family is engaged in health foods of functional foods. 21) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes on stress and mental condition | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Indexes on fatigue 2. Indexes on sleeping 3. Indexes on quality of life 4. Indexes on eating habit 5. Physical and clinical examinations. 6.Indexes for body composition. *Safety indexes 1.Doctor's questions 2.Side effects and adverse events 3.Subject's diary *Other indexes 1.Baseline characteristics 2.Height measurement | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed