Effect of DHA Containing Capsules to Improve the Sleep Condition
Conditions
Interventions
Oral ingestion of the test product (observation period I: 2 weeks) >
Washout (2 weeks) >
Oral ingestion of the control product (observation period II: 2 weeks)
Oral ingestion of the control product (observation period I: 2 weeks) >
Oral ingestion of the test product (observation period II: 2 weeks
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1]Japanese males aged 30-50 years [2]Individuals who are healthy and do not treat any disease [3]Individuals whose BMI is 18.5-25.0 kg/m^2 [4]Individuals who are not satisfied with sleeping (ex. insomnia, nocturnal awakening, early morning awakening, disrupted sleep) [5]Individuals who work on daytime of Monday to Friday and have Saturdays and Sundays off [6]Individuals whose sleeping hours from bedtime to wake-up time is over 4 hours [7]Individuals whose bedtime and wake-up time is regular and bedtime is before 0 AM [8]Individuals who sign the consent document after explanation of this study [9]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals who are a suspected patient, currently, or have treated with sleep apnea syndrome (SAS) [3]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [4]Individuals with serious anemia [5]Individuals whose observed data of AST (GOT) and ALT (GPT) is over 1.5 times of the standard value [6]Individuals whose observed data of UA is over 8.5mg/dL [7]Individuals whose observed data of indexes of lipid-based system is over 2.0 times of the standard value [8]Individuals whose observed data of HbA1c (NGSP) is over 7.0 [9]Individuals whose observed data of systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg [10]Individuals who are sensitive to test product or other foods, and medical products [11]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 1 month or will ingest those foods during the test period [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [13]Individuals who is a smoker [14]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [15]Individuals who participated in other clinical studies in the past three months [16]Individuals who are sensitive to the electrode pad [17]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Brain wave measurement(observation period I: 3 days before Week 0 and Week 2; observation period II: 3 days before Week 0 and Week 2) [2]Pittsburgh Quality of Sleep Index (PSQI-J)(observation period I: Week 0 and Week 2; observation period II: Week 0 and Week 2) [3]Obstructive Sleep Apnoea (OSA)(observation period I: 3 days before Week 0 to the last day of Week 2; observation period II: 3 days before Week 0 to the last day of Week 2) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed