Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
"slaap-onderzoek" (sleep study)
Study hypothesis
Milk containing lactium significantly increases duration and quality of sleep in persons with mild sleeping disorders.
Ethics approval
Not provided at time of registration
Study design
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Sleep Disorders
Intervention
Semi-skimmed milk with lactium compared to semi-skimmed milk without lactium.
Intervention type
Drug
Phase
Not Specified
Drug names
Lactium
Primary outcome measures
Sleep quality (assesed with the "Groningen Sleep Questionnaire") and sleep quantity.
Secondary outcome measures
Quality of Life and Sleepiness.
Overall trial start date
01/01/2007
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
200
Participant 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
Recruitment start date
01/01/2007
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Friesland Foods
Ede
6710 BD
Netherlands
Sponsor information
Organisation
Friesland Foods (The Netherlands)
Sponsor details
P.O. Box 159
Ede
6710 BD
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Friesland Foods (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary