None listed
Conditions
Interventions
Consumption of test foods for 8 weeks
Placebo (control food) for 8 weeks
Sponsors
Clinical Creative Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese men and women who are between 20 and 80 years of age at the time of consent (2) Those who have problems with sleep quality (3) Persons who have been fully informed of the purpose and content of the study and who have signed a consent form prior to the start of the study.
Exclusion criteria
Exclusion criteria: (1) Who is currently receiving treatment (including medication) for any disease (2) In particular, those who have been diagnosed with sleep disorders such as insomnia or sleep apnea and are taking drugs such as sleep inducing drugs or insomnia medications (including OTC drugs as well as prescription drugs) or receiving treatment with CPAP, mouthpiece, etc. (3) In particular, those who have been diagnosed and treated for allergic diseases such as atopic dermatitis, asthma, allergic rhinitis, etc. (4) In particular, those who suffer from post-coronary syndrome (5) Those who regularly consume Food for Specified Health Use, Food with Functional Labeling, or other food/beverage with possible functionality (6) Those whose BMI exceeds 30 (severely obese) (7) Those who are mainly in charge of taking care of those who need nursing care or infants (8) Those who work late at night, shift work, or heavy labor (9) Those who are pregnant, lactating, or intend to become pregnant (10) Those who cannot sleep alone on a single bedding (futon or bed, etc.) during the examination period. (11) Those who are not able to comply with the gentle sleep control (going to bed within +-2 hours of the declared bedtime and waking up within +-2 hours of the declared waking time) during the examination period, or those who are not sleeping regularly. Items that cannot be listed in the key exclusion criterria column are listed in other related information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Evaluate the daily changes in the occurrence rate of non-REM sleep stage 3 (N3), an objective index of sleep quantity and quality obtained from the sleep measurement results of each subject, during (1) the pre-measurement period and (2) the first, second, fourth and eighth week of intake of the test and target foods, during each sleep evaluation period, when the changes are stable. Calculate the average value for the latter 3 to 2 nights. Differences or changes in these averages between the test and control foods during each intake period will be evaluated using a linear mixed model, etc. (significance level: p < 0.05). | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Various objective indices of sleep quantity and quality (total sleep time, sleep efficiency, sleep latency, time awake after falling asleep, time on the floor after last awakening, total time or rate of occurrence of each sleep stage, delta-power, etc.) obtained from the sleep measurement results of each subject are evaluated for (1) the pre-measurement period and (2) the first, second, fourth and eighth weeks of consumption of the test and target foods. The daily changes during each sleep evaluation period of (1) the pre-measurement period, (2) Week 1, (3) Week 2, (4) Week 4, (5) Week 8, and (6) Week 8 will be evaluated and the average values for the last 3 to 2 nights when the changes are stable will be calculated. Differences or changes in these averages between the test and control foods during each intake period will be evaluated using linear mixed models, etc. (significance level: p < 0.05). (2) Evaluate the daily changes in the subjective sleep quality parameters scored on the MA version of the OSA Sleep Questionnaire for each subject during (1) the pre-measurement period and (2) the first, second, fourth, and eighth week of consumption of the test and target foods, and calculate the average value during the latter three to two nights when changes are stable (iii) Weeks 1, 2, 3, 4, and 8 of the intake period. The differences between the test and control foods in these averages during each intake period will be evaluated by t-test. (3) If differences between the test food and the control food are found in the scores of parameters related to the quality and quantity of sleep and each factor of subjective evaluation, the differences between the test food and the control food in the amount of activity, autonomic nervous activity, stress, brain health, and fatigue will also be evaluated to analyze the factors and spillover effects. | — |
Countries
Japan
Contacts
Public ContactRyosuke Kataoka
Clinical Creative Corporation Pharmaceuticals Division
Outcome results
None listed