Magnesium Nutrition and Sleep Behavior in Older Adults

Insomnia Clinical Trial

Official title:

Magnesium Nutrition and Sleep Behavior in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833092
• Other study ID #: GFHNRC014
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: March 6, 2015
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2015
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 51 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Malnutrition
• Nutritional Deficiency

Intervention

Dietary Supplement:
• Sugar Pill
Sugar pill supplementation for 9 weeks
• magnesium
300 milligrams daily for 8 weeks

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. — View Citation

Ford ES, Mokdad AH. Dietary magnesium intake in a national sample of US adults. J Nutr. 2003 Sep;133(9):2879-82. — View Citation

Hunt CD, Johnson LK. Magnesium requirements: new estimations for men and women by cross-sectional statistical analyses of metabolic magnesium balance data. Am J Clin Nutr. 2006 Oct;84(4):843-52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	9 weeks	No

External Links

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