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IRCT201109057479N1 IRCT 2011-09-15 National nutrition and food technology research institute - Shahid Beheshty university of medical sc Effects of magnesium on insomnia Effects of magnesium supplementation on insomnia in the elderly 2011-09-23 anticipated 46 Complete https://irct.ir/trial/7939 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Insomnia. Intervention 1: Intervention group will receive 250 mg magnesium supplement tablets. Bid for 8 weeks. Intervention 2: Control group will receive 250 mg placebo tablets containing starch. Bid for 8 weeks. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3703169 BACKGROUND:<br /> <br /> Nearly 50% of older adults have insomnia, with difficulty in getting to sleep, early awakening, or feeling unrefreshed on waking. With aging, several changes occur that can place one at risk for insomnia, including age-related changes in various circadian rhythms, environmental and lifestyle changes, and decreased nutrients intake, absorption, retention, and utilization. The natural N-methyl-D-aspartic acid (NMDA) antagonist and GABA agonist, Mg(2+), seems to play a key role in the regulation of sleep. The objective of this study was to determine the efficacy of magnesium supplementation to improve insomnia in elderly.<br /> MATERIALS AND METHODS:<br /> A double-blind randomized clinical trial was conducted in 46 elderly subjects, randomly allocated into the magnesium or the placebo group and received 500 mg magnesium or placebo daily for 8 weeks. Questionnaires of insomnia severity index (ISI), physical activity, and sleep log were completed at baseline and after the intervention period. Anthropometric confounding factors, daily intake of magnesium, calcium, potassium, caffeine, calories form carbohydrates, and total calorie intake, were obtained using 24-h recall for 3 days. Blood samples were taken at baseline and after the intervention period for analysis of serum magnesium, renin, melatonin, and cortisol. Statistical analyses were performed using SPSS19 and P values < 0.05 were considered as statistically significant.<br /> RESULTS:<br /> No significant differences were observed in assessed variables between the two groups at the baseline. As compared to the placebo group, in the experimental group, dietary magnesium supplementation brought about statistically significant increases in sleep time (P = 0.002), sleep efficiency (P = 0.03), concentration of serum renin (P < 0.001), and melatonin (P = 0.007), and also resulted in significant decrease of ISI score (P = 0.006), sleep onset latency (P = 0.02) and serum cortisol concentration (P = 0.008). Supplementation also resulted in marginally between-group significant reduction in early morning awakening (P = 0.08) and serum magnesium concentration (P = 0.06). Although total sleep time (P = 0.37) did not show any significant between-group differences.<br /> CONCLUSION:<br /> Supplementation of magnesium appears to improve subjective measures of insomnia such as ISI score, sleep efficiency, sleep time and sleep onset latency, early morning awakening, and likewise, insomnia objective measures such as concentration of serum renin, melatonin, and serum cortisol, in elderly people.
public Behnood Abbasi
Velenjak Street, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8870 4487 b.abbasi@nnftri.ac.ir National nutrition and food technology research institute-Shahid Beheshti University of Medical Scie scientific Masud Kimiagar
Velenjak Street, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2212 4333 smkimiagar@yahoo.com National nutrition and food technology research institute-Shahid Beheshti University of Medical Scie Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion Criteria: Willing to Cooperate; Age 60-75 years; Having Insomnia according to ISI and Sleep-log questionnaires; Dietary intake of Magnesium under 75% RDA; Serum Mg level under 0.95mmol/L. Exclusion Criteria: BMI higher than 35 kg/m2; Having alcohol or drug abuse; Having psychiatric disorders; Severe depression or recent stress; Having Transmeridian trip during last 6 weeks; Not willing to cooperate; Using loop diuretics, Cyclosporine, Digoxin, Amphotericin, Hormone replacement therapy; Having renal diseases, acute heart failure, restless legs syndrome, acute Apnea; Not using Mg supplement or placebo 60 years 75 years Both F51.0 A condition of unsatisfactory quantity and/or quality of sleep, which persists for a considerable period of time, including difficulty falling asleep, difficulty staying asleep, or early final wakening. Treatment - Drugs Treatment - Drugs Intervention group will receive 250 mg magnesium supplement tablets. Bid for 8 weeks. Control group will receive 250 mg placebo tablets containing starch. Bid for 8 weeks. Insomnia severity index. Timepoint: Baseline and after the intervention period. Method of measurement: ISI questionnaire. Sleep duration. Timepoint: Baseline and after the intervention period. Method of measurement: Sleeplog questionnaire. Total Serum Magnesium. Timepoint: Baseline and after the intervention period. Method of measurement: Atomic absorption spectrophotometry. Serum Cortisol. Timepoint: Baseline and after the intervention period. Method of measurement: ELISA. Serum Renin. Timepoint: Baseline and after the intervention period. Method of measurement: ELISA. Serum Melatonin. Timepoint: Baseline and after the intervention period. Method of measurement: ELISA. Total energy intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days. Carbohydrate intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days. Dietary Calcium intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days. Dietary potassium,k intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days. Dietary caffeine intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days. Weight. Timepoint: Baseline and after the intervention period. Method of measurement: Scale. Physical activity. Timepoint: Baseline and after the intervention period. Method of measurement: Physical activity questionnaire. Depression. Timepoint: Baseline and after the intervention period. Method of measurement: SCL-90 questionnaire. Quality of life. Timepoint: Baseline and after the intervention period. Method of measurement: GHQ-28. Loose stool. Timepoint: Baseline and after the intervention period. Method of measurement: Asking. National nutrition and food technology research institute - Shahid Beheshty university of medical sc Approved 2011-08-06 Shahid Beheshti university of medical sciences Velenjak Street, Shahid Chamran Highway. Tehran Iran (Islamic Republic of)