Effects of melatonin administration on mental health parameters, metabolic and genetic profiles in women with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled trial.
Study Goal
The researchers aimed to evaluate the effects of melatonin supplementation on mental health, metabolic parameters, and genetic markers in women with polycystic ovary syndrome (PCOS).
Results Summary
Melatonin significantly improved sleep quality, reduced depression and anxiety scores, lowered insulin resistance and cholesterol levels, and upregulated beneficial gene expression related to insulin and lipid metabolism.
Population
Women aged 18-40 with PCOS.
Effective Dosage
10 mg melatonin (two 5 mg capsules) once daily before bedtime.
Duration
12 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin supplementation | decrease | Pittsburgh Sleep Quality Index | women with polycystic ovary syndrome (PCOS) | β -2.15; 95% CI, -3.62, -0.68; P = 0.005 | significantly decreased | #1 |
melatonin supplementation | decrease | Beck Depression Inventory index | women with polycystic ovary syndrome (PCOS) | β -3.62; 95% CI, -5.53, -1.78; P<0.001 | significantly decreased | #2 |
melatonin supplementation | decrease | Beck Anxiety Inventory index | women with polycystic ovary syndrome (PCOS) | β -1.95; 95% CI, -3.41, -0.48; P = 0.01 | significantly decreased | #3 |
melatonin administration | decrease | serum insulin | women with polycystic ovary syndrome (PCOS) | β -1.20 µIU/mL; 95% CI, -2.14, -0.26; P = 0.01 | significantly reduced | #4 |
melatonin administration | decrease | homeostasis model of assessment-insulin resistance (HOMA-IR) | women with polycystic ovary syndrome (PCOS) | β -0.28; 95% CI, -0.50, -0.05; P = 0.01 | significantly reduced | #5 |
melatonin administration | decrease | serum total-cholesterol levels | women with polycystic ovary syndrome (PCOS) | β -7.96 mg/dL; 95% CI, -13.75, -2.17; P = 0.008 | significantly reduced | #6 |
melatonin administration | decrease | LDL-cholesterol levels | women with polycystic ovary syndrome (PCOS) | β -5.88 mg/dL; 95% CI, -11.42, -0.33; P = 0.03 | significantly reduced | #7 |
melatonin administration | increase | quantitative insulin sensitivity check index (QUICKI) | women with polycystic ovary syndrome (PCOS) | β 0.008; 95% CI, 0.002, 0.014; P = 0.007 | significantly increased | #8 |
melatonin supplementation | increase | gene expression of peroxisome proliferator-activated receptor gamma (PPAR-γ) | women with polycystic ovary syndrome (PCOS) | P = 0.004 | upregulated | #9 |
melatonin supplementation | increase | gene expression of low-density lipoprotein receptor (LDLR) | women with polycystic ovary syndrome (PCOS) | P = 0.01 | upregulated | #10 |
OBJECTIVE: The aim of this study was to evaluate the effect of melatonin supplementation on mental health parameters, metabolic and genetic parameters in women suffering from polycystic ovary syndrome (PCOS). METHODS: This randomized, double-blinded, placebo-controlled clinical trial was performed on 58 subjects, aged 18-40 years old. Subjects were randomly allocated to take either 10 mg melatonin (2 melatonin capsules, 5 mg each) (n = 29) or placebo (n = 29) once a day 1 h before bedtime for 12 weeks. Glycemic control and lipid profiles were measured at baseline and after the 12-week intervention. Using RT-PCR method, gene expression related to insulin and lipid metabolism was conducted on peripheral blood mononuclear cells (PBMCs) of PCOS women. RESULTS: Melatonin supplementation significantly decreased Pittsburgh Sleep Quality Index (β -2.15; 95% CI, -3.62, -0.68; P = 0.005), Beck Depression Inventory index (β -3.62; 95% CI, -5.53, -1.78; P<0.001) and Beck Anxiety Inventory index (β -1.95; 95% CI, -3.41, -0.48; P = 0.01) compared with the placebo. In addition, melatonin administration, compared with the placebo, significantly reduced serum insulin (β -1.20 µIU/mL; 95% CI, -2.14, -0.26; P = 0.01), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.28; 95% CI, -0.50, -0.05; P = 0.01), serum total- (β -7.96 mg/dL; 95% CI, -13.75, -2.17; P = 0.008) and LDL-cholesterol levels (β -5.88 mg/dL; 95% CI, -11.42, -0.33; P = 0.03), and significantly increased the quantitative insulin sensitivity check index (QUICKI) (β 0.008; 95% CI, 0.002, 0.014; P = 0.007). Moreover, melatonin supplementation upregulated gene expression of peroxisome proliferator-activated receptor gamma (PPAR-γ) (P = 0.004) and low-density lipoprotein receptor (LDLR) (P = 0.01) compared with the placebo. CONCLUSIONS: Overall, melatonin administration for 12 weeks had beneficial effects on mental health parameters, insulin levels, HOMA-IR, QUICKI, total- and LDL-cholesterol levels, and gene expression of PPAR-γ and LDLR among women with PCOS.