Effect of milk containing lactium on subjective sleep parameters

Completed

• Conditions: Sleep Disorders; Mental and Behavioural Disorders; Physiological disturbances

• Registration Number: ISRCTN42343515
• Lead Sponsor: Friesland Foods (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. Healthy adults 20 to 60 years of age
2. With regular and normal Dutch eating habits (consuming mostly three main meals including breakfast)
3. A regular lifestyle
4. With sleeping problems present during more than one month prior to the start of the study and during three 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 three times awake at night or during more than 45 minutes awake at night

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 more than 21 units/week
8. Frequent intense sport practice (more than ten 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified