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Effect of milk containing Lactium on subjective sleep parameters.


- candidate number2299
- NTR NumberNTR817
- ISRCTNISRCTN42343515
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR26-okt-2006
- Secondary IDsN/A 
- Public TitleEffect of milk containing Lactium on subjective sleep parameters.
- Scientific TitleEffect of milk containing Lactium on subjective sleep parameters.
- ACRONYM"slaap-onderzoek" (sleep study)
- hypothesisMilk containing Lactium significantly increases duration and quality of sleep in persons with mild sleeping disorders.
- Healt Condition(s) or Problem(s) studiedSleep disorders
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate1-apr-2007
- Target number of participants200
- InterventionsSemi-skimmed milk with Lactium compared to semi-skimmed milk without Lactium.
- Primary outcomeSleep quality (assesed with the "Groningen Sleep Questionnaire") and sleep quantity.
- Secondary outcomeQuality of Life en Sleepiness.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Astrid Bakker-Zierikzee
- CONTACT for SCIENTIFIC QUERIES Astrid Bakker-Zierikzee
- Sponsor/Initiator Friesland Foods
- Funding
(Source(s) of Monetary or Material Support)
Friesland Foods
- PublicationsN/A
- Brief summaryEffect of milk containing Lactium® on subjective sleep parameters.

Introduction:
The quality of sleep is intrinsically linked to quality of life. According to CBS thirty eight percent of the middle-aged women in the study (> 45 y) responded ‘yes’ to the question ‘Have you had sleeping problems in the past 14 days?’ Lactium® is a protein hydrolysate derived from enzymatic treatment of milk (á-S1) casein and has prooven anti-stress effects.

Objective:
The objective of the study is to study the effects of milk containing Lactium® on sleep in 200 adults with minor sleeping problems.

Methods:
The study design is a randomized, placebo controlled, double blind intervention study, with parallel groups. A total of 200 subjects will be randomised to one of the two treatments: reference (normal semi-skimmed) milk and semi-skimmed milk with Lactium. Each subject will use the study milk during 2 weeks, half-an-hour before going to sleep.

Primary outcome measures:
Daily questionnaires: Sleepiness (Scored by the Stanford Sleeping Scale in the evening), Sleep quality (Scored by the Groningen Sleep Questionnaire in the morning) and Sleep quantity (Scored in the morning).
- Main changes (audit trail)
- RECORD26-okt-2006 - 16-nov-2009


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