Healthy subjects with self-reported poor sleep
Conditions
Interventions
Group 1: Daily intake of 2 capsules magnesium bisglycinate (250 mg magnesium and 1520mg glycine)
Group 2: Daily intake of 2 placebo capsules (1770 mg cellulose)
Sponsors
Gottfried Wilhelm-Leibniz-Universität Hannover Institut für Lebensmittelwissenschaft und Humanernährung
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Self-reported bad sleep (RIS score >12); BMI between 18,5 and 35; Willingness to consume 2 capsules of the study product for 4 weeks.
Exclusion criteria
Exclusion criteria: Change in use of any medication and food ingredients affecting sleep and mood prior to intervention. Consumption of dietary supplements that contain magnesium (>200 mg/day) or glycine (1 g/day) <1 month prior to intervention. Severe chronic diseases (renal insufficiency, liver disease, concurrent cancer). No concurrent treatment for sleep disorder or depression. No major change in sleeping rhythm for professional (e.g., shift work) or private reasons. Chronic diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease, pancreatic insufficiency) and chronic diseases involving the immune system (i.e., Crohn’s disease, ulcerative colitis, rheumatoid arthritis, multiple sclerosis). Sleep apnea. Regular intake of laxatives. Pregnancy or breastfeeding. Alcohol, drug and/or medication dependence. Subjects not capable of giving consent. Refusal or withdrawal of consent by the subject. Concurrent participation in another clinical trial or participation within the past 30 days. Planned surgery within the next 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality: Insomnia Severity Index (ISI) - Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep: Regensburg Insomnia Scale (RIS) Single-Item Sleep Quality Scale (SQS) 14 day sleep diary Stress: Perceived Stress Scale (PSS) Daytime Fatigue: Epworth Sleepiness Scale (ESS) Fatigue Severity Scale (FSS) Mood: Positive and Negative Affect Schedule (PANAS) Anxiety and Depression: Patient Health Questionnaire-4 (PHQ-4) Magnesium-rich diet: Classification by simplified consumption frequency | — |
Countries
Germany
Contacts
Public ContactJulius Schuster
Gottfried Wilhelm-Leibniz-Universität Hannover Institut für Lebensmittelwissenschaft und Humanernährung
Outcome results
None listed