| - candidate number | 2299 |
| - NTR Number | NTR817 |
| - ISRCTN | ISRCTN42343515 |
| - 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 |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - 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. |
| - Timepoints | N/A |
| - 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 |
| - Funding (Source(s) of Monetary or Material Support) | Friesland Foods |
| - Publications | N/A |
| - Brief summary | Effect 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) | |
| - RECORD | 26-okt-2006 - 16-nov-2009 |
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