Journal Article
2025; 46(4): 232-248
PubMed PMID: 41283863
Citation
Keywords:
Humans, Male, Female, Middle Aged, Hypercholesterolemia:drug therapy, Dietary Supplements, Berberine:administration & dosage, Plant Extracts:administration & dosage, Amaranthus, Adult, Brain-Derived Neurotrophic Factor:blood, Cholesterol, LDL:blood, C-Reactive Protein:metabolism, Prospective Studies, Anti-Inflammatory Agents:therapeutic use, Hypolipidemic Agents:therapeutic use, Triglycerides:blood, Cholesterol, HDL:blood,.
BACKGROUND: Nutraceutical combinations represent a potential strategy for managing mild hypercholesterolemia in patients who cannot tolerate or do not require statin therapy. In this two-group prospective comparative study, we evaluated the effects of a nutraceutical formulation containing berberine (500 mg), bergamot extract (200 mg), and Amaranthus cruentus extract (30 mg) on lipid, inflammatory, and neurotrophic parameters in low-risk subjects with mild-to-moderate hypercholesterolemia.
METHODS: Sixty subjects with low-density-lipoprotein cholesterol (LDL-C) 115-180 mg/dL, total cholesterol (TC) 200-260 mg/dL, triglycerides <250 mg/dL, and cardiovascular risk < 20% received either one tablet daily (Group 1, n = 30) or two tablets daily (Group 2, n = 30) of the study supplement for 8 weeks. Primary outcomes included TC, LDL-C, oxidized LDL (oxLDL), and high-density-lipoprotein cholesterol (HDL-C). Secondary outcomes were triglycerides, high-sensitivity C-reactive protein (hs-CRP), and serum brain-derived neurotrophic factor (BDNF).
RESULTS: Both regimens significantly reduced TC and LDL-C at 8 weeks. Group 2 demonstrated superior reductions in LDL-C (-25.2% versus -14.5%, p < 0.05), oxLDL (-23.1% versus -11.8%, p < 0.05), and hs-CRP (-31.3% versus -6.7%, p < 0.001) compared with Group 1. Group 2 also showed significant increases in HDL-C (+14.9% versus +2.2%, p < 0.05) and BDNF levels (+16.3% versus +2.7%, p<0.001). Both regimens were well-tolerated with no adverse events or hepatic/muscular parameter changes.
CONCLUSION: This nutraceutical formulation effectively and safely reduced TC and LDL-C in low-risk subjects with mild hypercholesterolemia. The twice-daily regimen provided superior lipid improvements and increased HDL-C and BDNF levels, indicating additional antioxidant, anti-inflammatory, and neuroprotective properties warranting further investigation....
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