The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia
Background: Hyperlipidemia is associated with a higher rate of cardiovascular, cerebrovascular, and peripheral vascular disease. Conventional drugs such as statins are effective in controlling hyperlipidemia; however, they are associated with various side effects, especially myalgia. Nutraceutical l...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-11-01
|
| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1280234/full |
| _version_ | 1797450029872447488 |
|---|---|
| author | Michel P. Hermans Yvan Dierckxsens Isabelle Janssens Laurence Seidel Adelin Albert Sylvie A. Ahn Michel F. Rousseau Amjad Khan Amjad Khan |
| author_facet | Michel P. Hermans Yvan Dierckxsens Isabelle Janssens Laurence Seidel Adelin Albert Sylvie A. Ahn Michel F. Rousseau Amjad Khan Amjad Khan |
| author_sort | Michel P. Hermans |
| collection | DOAJ |
| description | Background: Hyperlipidemia is associated with a higher rate of cardiovascular, cerebrovascular, and peripheral vascular disease. Conventional drugs such as statins are effective in controlling hyperlipidemia; however, they are associated with various side effects, especially myalgia. Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to statins. Substantial preclinical and clinical evidence suggests that extracts of amla, walnut, and olive, and red yeast rice (RYR) powder possess significant antihyperlipidemic effects.Aims: This study aimed to evaluate the efficacy, safety, and patient satisfaction of a combined supplementation of standardized dry extracts of amla fruit (500 mg), walnut leaves (50 mg), olive fruit (25 mg), and RYR powder (33.6 mg) (Cholesfytol NG®) in hypercholesterolemic patients.Methods: This was a real-life setting, retrospective, observational, single-arm, non-randomized study in hypercholesterolemic patients (total cholesterol (TC) ≥ 200 mg/dL or low-density lipoprotein-cholesterol (LDL-C) ≥ 130 mg/dL), enrolled at 57 general practitioner (GP) surgeries in Belgium from March 2020 to January 2022. These patients received a GP-prescribed daily single dosage of two oral tablets of Cholesfytol NG® supplementation for 2 months to overcome their hypercholesterolemia in the absence of a conventional lipid-lowering drug (n = 208) or with a lipid-lowering drug (n = 13). At 2-month follow-up, the lipid profile was re-evaluated, alongside a patient’s questionnaire on treatment general satisfaction and willingness to pursue supplementation.Results: After supplementation, TC decreased by 15%, LDL-C by 19%, non-high-density lipoprotein-cholesterol (non-HDL-C) by 20% (all p < 0.0001), triglycerides (TG) by 9% (p = 0.0028) (−18.4%, p = 0.0042, in patients with baseline TG > 180 mg/dL, n = 58), and remnant cholesterol (RC) by 12% (p = 0.0001). These changes were unaffected by statin intolerance status in patients who received Cholesfytol NG® alongside statin. The supplement was well tolerated by all patients, and no serious adverse events or supplement-emergent effects were reported. Most patients were satisfied with the supplementation and wanted to pursue the nutraceutical.Conclusion: According to the results of this study, a combined supplementation of amla, walnut, and olive extracts, and RYR powder exerts a significant antihyperlipidemic effect, leading to a decrease in circulatory LDL-C and RC levels in patients with hypercholesterolemia. The supplementation bears excellent safety and tolerability, and is rated as satisfactory and pursuable, even among patients with statin intolerance.Clinical Trial Registration: clinicaltrials.gov; identifier number: NCT06002893 |
| first_indexed | 2024-03-09T14:34:34Z |
| format | Article |
| id | doaj.art-5a869464aa5d44908a8c39917dd29126 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-09T14:34:34Z |
| publishDate | 2023-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-5a869464aa5d44908a8c39917dd291262023-11-27T14:41:40ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-11-011410.3389/fphar.2023.12802341280234The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemiaMichel P. Hermans0Yvan Dierckxsens1Isabelle Janssens2Laurence Seidel3Adelin Albert4Sylvie A. Ahn5Michel F. Rousseau6Amjad Khan7Amjad Khan8Division of Endocrinology and Nutrition, Cliniques Universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), Université Catholique de Louvain, Brussels, BelgiumLaboratoire Tilman, Baillonville, BelgiumLaboratoire Tilman, Baillonville, BelgiumB-STAT, Centre Hospitalier Universitaire, Liège, BelgiumB-STAT, Centre Hospitalier Universitaire, Liège, BelgiumDivision of Cardiology, Cliniques Universitaires St-Luc and Pôle de Recherche Cardiovasculaire, Institut de Recherche Expérimentale et Clinique (IREC), Université Catholique de Louvain, Brussels, BelgiumDivision of Cardiology, Cliniques Universitaires St-Luc and Pôle de Recherche Cardiovasculaire, Institut de Recherche Expérimentale et Clinique (IREC), Université Catholique de Louvain, Brussels, BelgiumNuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, United KingdomDepartment of Biochemistry, Liaquat University of Medical and Health Sciences, Jamshoro, PakistanBackground: Hyperlipidemia is associated with a higher rate of cardiovascular, cerebrovascular, and peripheral vascular disease. Conventional drugs such as statins are effective in controlling hyperlipidemia; however, they are associated with various side effects, especially myalgia. Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to statins. Substantial preclinical and clinical evidence suggests that extracts of amla, walnut, and olive, and red yeast rice (RYR) powder possess significant antihyperlipidemic effects.Aims: This study aimed to evaluate the efficacy, safety, and patient satisfaction of a combined supplementation of standardized dry extracts of amla fruit (500 mg), walnut leaves (50 mg), olive fruit (25 mg), and RYR powder (33.6 mg) (Cholesfytol NG®) in hypercholesterolemic patients.Methods: This was a real-life setting, retrospective, observational, single-arm, non-randomized study in hypercholesterolemic patients (total cholesterol (TC) ≥ 200 mg/dL or low-density lipoprotein-cholesterol (LDL-C) ≥ 130 mg/dL), enrolled at 57 general practitioner (GP) surgeries in Belgium from March 2020 to January 2022. These patients received a GP-prescribed daily single dosage of two oral tablets of Cholesfytol NG® supplementation for 2 months to overcome their hypercholesterolemia in the absence of a conventional lipid-lowering drug (n = 208) or with a lipid-lowering drug (n = 13). At 2-month follow-up, the lipid profile was re-evaluated, alongside a patient’s questionnaire on treatment general satisfaction and willingness to pursue supplementation.Results: After supplementation, TC decreased by 15%, LDL-C by 19%, non-high-density lipoprotein-cholesterol (non-HDL-C) by 20% (all p < 0.0001), triglycerides (TG) by 9% (p = 0.0028) (−18.4%, p = 0.0042, in patients with baseline TG > 180 mg/dL, n = 58), and remnant cholesterol (RC) by 12% (p = 0.0001). These changes were unaffected by statin intolerance status in patients who received Cholesfytol NG® alongside statin. The supplement was well tolerated by all patients, and no serious adverse events or supplement-emergent effects were reported. Most patients were satisfied with the supplementation and wanted to pursue the nutraceutical.Conclusion: According to the results of this study, a combined supplementation of amla, walnut, and olive extracts, and RYR powder exerts a significant antihyperlipidemic effect, leading to a decrease in circulatory LDL-C and RC levels in patients with hypercholesterolemia. The supplementation bears excellent safety and tolerability, and is rated as satisfactory and pursuable, even among patients with statin intolerance.Clinical Trial Registration: clinicaltrials.gov; identifier number: NCT06002893https://www.frontiersin.org/articles/10.3389/fphar.2023.1280234/fullCholesfytol NG®hyperlipidemiaLDL-Cremnant cholesterolamlared yeast rice |
| spellingShingle | Michel P. Hermans Yvan Dierckxsens Isabelle Janssens Laurence Seidel Adelin Albert Sylvie A. Ahn Michel F. Rousseau Amjad Khan Amjad Khan The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia Frontiers in Pharmacology Cholesfytol NG® hyperlipidemia LDL-C remnant cholesterol amla red yeast rice |
| title | The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia |
| title_full | The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia |
| title_fullStr | The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia |
| title_full_unstemmed | The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia |
| title_short | The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia |
| title_sort | antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla emblica officinalis walnut juglans regia olive olea europaea and red yeast rice monascus purpureus powder reduction in circulatory low density lipoprotein cholesterol ldl c and remnant cholesterol rc levels in patients with hypercholesterolemia |
| topic | Cholesfytol NG® hyperlipidemia LDL-C remnant cholesterol amla red yeast rice |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1280234/full |
| work_keys_str_mv | AT michelphermans theantihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrcleve AT yvandierckxsens theantihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrcleve AT isabellejanssens theantihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrcleve AT laurenceseidel theantihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrcleve AT adelinalbert theantihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrcleve AT sylvieaahn theantihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrcleve AT michelfrousseau theantihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrcleve AT amjadkhan theantihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrcleve AT amjadkhan theantihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrcleve AT michelphermans antihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrclevelsi AT yvandierckxsens antihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrclevelsi AT isabellejanssens antihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrclevelsi AT laurenceseidel antihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrclevelsi AT adelinalbert antihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrclevelsi AT sylvieaahn antihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrclevelsi AT michelfrousseau antihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrclevelsi AT amjadkhan antihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrclevelsi AT amjadkhan antihyperlipidemiceffectofacombinedsupplementofstandardizeddryextractsofamlaemblicaofficinaliswalnutjuglansregiaoliveoleaeuropaeaandredyeastricemonascuspurpureuspowderreductionincirculatorylowdensitylipoproteincholesterolldlcandremnantcholesterolrclevelsi |