Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.
Study Goal
The researchers aimed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease.
Results Summary
Melatonin significantly improved UPDRS part I score, sleep quality, depression, anxiety, inflammation markers, antioxidant capacity, insulin levels, and lipid profiles compared to placebo.
Population
60 patients with Parkinson's disease.
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 | Unified Parkinson's Disease Rating Scale (UPDRS) part I score | patients with PD | β -2.33; 95% CI, -3.57, -1.09; P < 0.001 | significantly reduced | #1 |
melatonin supplementation | decrease | Pittsburgh Sleep Quality Index (PSQI) | patients with PD | β -1.82; 95% CI, -3.36, -0.27; P = 0.02 | significantly reduced | #2 |
melatonin supplementation | decrease | Beck Depression Inventory (BDI) | patients with PD | β -3.32; 95% CI, -5.23, -1.41; P = 0.001 | significantly reduced | #3 |
melatonin supplementation | decrease | Beck Anxiety Inventory (BAI) | patients with PD | β -2.22; 95% CI, -3.84, -0.60; P = 0.008 | significantly reduced | #4 |
melatonin supplementation | decrease | serum high sensitivity C-reactive protein (hs-CRP) | patients with PD | β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003 | significant reduction | #5 |
melatonin supplementation | increase | plasma total antioxidant capacity (TAC) | patients with PD | β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001 | significant elevation | #6 |
melatonin supplementation | increase | total glutathione (GSH) levels | patients with PD | β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001 | significant elevation | #7 |
melatonin supplementation | decrease | serum insulin levels | patients with PD | β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009 | significantly decreased | #8 |
melatonin supplementation | decrease | homeostasis model of assessment-insulin resistance (HOMA-IR) | patients with PD | β -0.47; 95% CI, -0.80, -0.13; P = 0.007 | significantly decreased | #9 |
melatonin supplementation | decrease | total-cholesterol | patients with PD | β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03 | significantly decreased | #10 |
melatonin supplementation | decrease | LDL-cholesterol | patients with PD | β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04 | significantly decreased | #11 |
melatonin supplementation | no change | other metabolic profiles | patients with PD | - | did not affect | #12 |
OBJECTIVE: This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD). METHODS: This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks. RESULTS: Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo. CONCLUSIONS: Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.