Milk containing Lactium significantly increases duration and quality of sleep in persons with mild sleeping disorders.
ID
Bron
Verkorte titel
Aandoening
Mild Sleeping Disorders
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Sleep quality (assesed with the "Groningen Sleep Questionnaire") and sleep quantity.
Achtergrond van het onderzoek
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).
Doel van het onderzoek
Milk containing Lactium significantly increases duration and quality of sleep in persons with mild sleeping disorders.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Semi-skimmed milk with Lactium compared to semi-skimmed milk without Lactium.
Publiek
P.O. Box 159
Astrid Bakker-Zierikzee
Ede 6710 BD
The Netherlands
+31 (0)318 439368
astrid.bakker@frieslandfoods.com
Wetenschappelijk
P.O. Box 159
Astrid Bakker-Zierikzee
Ede 6710 BD
The Netherlands
+31 (0)318 439368
astrid.bakker@frieslandfoods.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL804 |
| NTR-old | NTR817 |
| Ander register | : N/A |
| ISRCTN | ISRCTN42343515 |