Effect of milk containing lactium on subjective sleep parameters
| ISRCTN | ISRCTN42343515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42343515 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 29/12/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Astrid Bakker-Zierikzee
Scientific
Scientific
Friesland Foods
P.O. Box 159
Ede
6710 BD
Netherlands
Study information
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Not provided at time of registration |
| Condition | Sleep Disorders |
| Intervention | Semi-skimmed milk with lactium compared to semi-skimmed milk without lactium. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lactium |
| Primary outcome measure | Sleep quality (assesed with the "Groningen Sleep Questionnaire") and sleep quantity. |
| Secondary outcome measures | Quality of Life and Sleepiness. |
| Overall study start date | 01/01/2007 |
| Overall study end date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 200 |
| 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 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
Study participating centre
Friesland Foods
Ede
6710 BD
Netherlands
6710 BD
Netherlands
Sponsor information
Friesland Foods (The Netherlands)
Industry
Industry
P.O. Box 159
Ede
6710 BD
Netherlands
| Website | http://www.fcdf.com/ |
|---|---|
"ROR" |
https://ror.org/025mtxh67 |
Funders
Funder type
Industry
Friesland Foods (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
