|- candidate number||2299|
|- NTR Number||NTR817|
|- Date ISRCTN created||28-dec-2006|
|- date ISRCTN requested||18-dec-2006|
|- Date Registered NTR||26-okt-2006|
|- Secondary IDs||N/A |
|- Public Title||Effect of milk containing Lactium on subjective sleep parameters.|
|- Scientific Title||Effect of milk containing Lactium on subjective sleep parameters.|
|- ACRONYM||"slaap-onderzoek" (sleep study)|
|- hypothesis||Milk containing Lactium significantly increases duration and quality of sleep in persons with mild sleeping disorders. |
|- Healt Condition(s) or Problem(s) studied||Sleep disorders|
|- 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||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.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2007|
|- planned closingdate||1-apr-2007|
|- Target number of participants||200|
|- Interventions||Semi-skimmed milk with Lactium compared to semi-skimmed milk without Lactium.|
|- Primary outcome||Sleep quality (assesed with the "Groningen Sleep Questionnaire") and sleep quantity.|
|- Secondary outcome||Quality of Life en Sleepiness.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Astrid Bakker-Zierikzee|
|- CONTACT for SCIENTIFIC QUERIES|| Astrid Bakker-Zierikzee|
|- Sponsor/Initiator ||Friesland Foods|
(Source(s) of Monetary or Material Support)
|- Brief summary||Effect of milk containing Lactium®
on subjective sleep parameters.
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.
The objective of the study is to study the effects of milk containing Lactium® on sleep in 200 adults with minor sleeping problems.
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)|
|- RECORD||26-okt-2006 - 16-nov-2009|