Condition category
Mental and Behavioural Disorders
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
29/12/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Astrid Bakker-Zierikzee

ORCID ID

Contact details

Friesland Foods
P.O. Box 159
Ede
6710 BD
Netherlands

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

http://www.fcdf.com/

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

Publication citations

Additional files

Editorial Notes