Effect of milk containing Lactium on subjective sleep parameters.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR817
• Date of registration: 26/10/2006
• Primary sponsor: Friesland Foods
• Public title: Effect of milk containing Lactium on subjective sleep parameters.
• Scientific title: Effect of milk containing Lactium on subjective sleep parameters. - "slaap-onderzoek" (sleep study)
• Date of first enrolment: 1/1/2007
• Target sample size: 200
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=817
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Astrid Bakker-Zierikzee

• Name: Astrid Bakker-Zierikzee

Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Sleep disorders

Intervention(s)

Semi-skimmed milk with Lactium compared to semi-skimmed milk without Lactium.

Primary Outcome(s)

Sleep quality (assesed with the "Groningen Sleep Questionnaire") and sleep quantity.

Secondary Outcome(s)

Quality of Life en Sleepiness.

Secondary ID(s)

ISRCTN42343515

N/A

Source(s) of Monetary Support

Friesland Foods