Insomnia, Nutritional Deficiency
Conditions
Keywords
magnesium, Nutritional Requirements, Sleep
Brief summary
Insomnia is not a natural part of aging but is higher in older adults because of a variety of factors common in later life. One of these factors may be a deficient magnesium status. This study will look at whether or not magnesium supplementation will improve sleep.
Detailed description
Insomnia affects approximately one-third of older Americans. More than half of all people aged 65 and older experience sleep problems. The prevalence of insomnia and other sleep disorders is not a natural part of aging but is high in older adults because of a variety of factors common in late life. One of those factors may be a deficient magnesium status. There is a close association between sleep architecture, especially slow wave sleep, and activity in the glutamatergic and gamma-aminobutyric acid (GABA) system. Because magnesium is a natural N-methyl-D-aspartate (NMDA)antagonist and GABA agonist, magnesium apparently plays a key role in the regulation of sleep. Such a role is supported by supplementation, correlation, and animal studies showing that magnesium intake or status affects sleep organization.
Interventions
DIETARY_SUPPLEMENTSugar Pill
Sugar pill supplementation for 9 weeks
DIETARY_SUPPLEMENTmagnesium
300 milligrams daily for 8 weeks
Sponsors
USDA Grand Forks Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* have sleep complaints * Score greater than 5 on Pittsburgh Global Sleep Quality Index
Exclusion criteria
* taking medications that affect sleep * taking 100 milligrams or more of magnesium * body mass index of 40 or higher * abnormal breathing conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Pittsburgh Sleep Quality Index | 9 weeks | Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in 2007 and 2008 by the USDA Grand Forks Human Nutrition Research Center staff in North Dakota.
Pre-assignment details
425 applications were received. 215 people did not meet the eligibility criteria. 99 people withdrew their application. 111 people were assigned to groups.
Participants by arm
| Arm | Count |
|---|---|
| Sugar Pill zero magnesium supplementation | 54 |
| Magnesium 300 milligrams of magnesium daily | 57 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | constipation | 0 | 1 |
| Overall Study | Diarrhea | 0 | 2 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Magnesium | Sugar Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 14 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 40 Participants | 89 Participants |
| Age, Continuous | 58.2 years STANDARD_DEVIATION 6.2 | 60.4 years STANDARD_DEVIATION 8.7 | 59.3 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment United States | 57 participants | 54 participants | 111 participants |
| Sex: Female, Male Female | 43 Participants | 39 Participants | 82 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 57 |
| serious Total, serious adverse events | 0 / 54 | 0 / 57 |
Outcome results
Primary
Global Pittsburgh Sleep Quality Index
Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep.
Time frame: 9 weeks
Population: Data from 4 participants (3 on sugar pill, 1 on magnesium) were omitted from statistical analysis because of protocol violations discovered near end of study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar Pill | Global Pittsburgh Sleep Quality Index | 6.30 score on a scale | Standard Error 0.37 |
| Magnesium | Global Pittsburgh Sleep Quality Index | 6.96 score on a scale | Standard Error 0.36 |