Mild Sleeping Disorders
Conditions
Interventions
Semi-skimmed milk with Lactium compared to semi-skimmed milk without Lactium.
Sponsors
Friesland Foods Western Europe, Ede, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adults 20-60 years of age; 2. With regular and normal Dutch eating habits (consuming mostly three main meals including breakfast) and; 3. A regular lifestyle; 4. With sleeping problems present during more than 1 month prior to the start of the study and during 3 or more nights a week; 5. Having given their written informed consent; 6. Willing to comply with the study procedures; 7. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years; 8. Sleeping problems are defined as more than 30 minutes awake after lights out or more than 3 times awake at night or during more than 45 min awake at night.
Exclusion criteria
Exclusion criteria: 1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before the start of this study; 2. Participation in any non-invasive clinical trial up to 30 days before the start of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances; 3. Mental status that is incompatible with the proper conduct of the study; 4. Intended vacation in the study period; 5. Having a history of medical or surgical events that may significantly affect the study outcome; 6. Use of medication for sleeping problems within three months prior to the study, and during the study; 7. Alcohol consumption > 21 units/week; 8. Frequent intense sport practice (more than 10 hours a week); 9. Reported participation on night shift work; 10. Pregnant or lactating or wishing to became pregnant in the period of the study; 11. Not having a general practitioner; 12. Not willing to accept information-transfer concerning participation in the study, or information regarding her health, like findings at anamnesis and eventual adverse events to and from her general practitioner; 13. Depression, restless legs, sleep apnoea syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality (assesed with the "Groningen Sleep Questionnaire") and sleep quantity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life en Sleepiness. | — |
Contacts
Public ContactAstrid Bakker-Zierikzee
Friesland Foods, P.O. Box 159
Outcome results
None listed