Trial reportHigh blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension2015
Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial.
Trial report in High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of a New Combination of Nutraceutics (LopiGLIK®) on Cardiovascular Risk
Randomized Trial to Evaluate the Effects of Two Different Nutraceutical Therapies on Endothelial Function, Platelet Aggregation, and Coronary Flow Reserve in Hypercholesterolemic Patients at Moderate Cardiovascular Risk
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Integrative Evidence on Mulberry Extract for Modulating Metabolic Risk Factors Associated with Vascular Dementia.International journal of molecular sciences · 2025Pooled it
- Pooled it
- A meta-analysis of efficacy of Morus alba Linn. to improve blood glucose and lipid profile.European journal of nutrition · 2017Pooled it
- Effects of a Novel Fixed Combination of Nutraceuticals on Serum Uric Acid Concentrations and the Lipid Profile in Asymptomatic Hyperuricemic Patients : Results from the PICONZ-UA Study.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2016Trial
- Review
- Does EFSA statement on Monacolin content of nutraceutical combinations impair their lipid lowering effect? The LopiGLIK experience.Clinical diabetes and endocrinology · 2024Article
- Mulberry leaf extract inhibits obesity and protects against diethylnitrosamine-induced hepatocellular carcinoma in rats.Journal of traditional and complementary medicine · 2024Article
- The role of selected nutraceuticals in management of prediabetes and diabetes: An updated review of the literature.Phytotherapy research : PTR · 2022Review
- Berberine, a Herbal Metabolite in the Metabolic Syndrome: The Risk Factors, Course, and Consequences of the Disease.Molecules (Basel, Switzerland) · 2022Review
- Acute and Long Term Effects of a Nutraceutical Combination on Lipid Profile, Glucose Metabolism and Vascular Function in Patients with Dyslipidaemia with and Without Cigarette Smoking.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2021Article
- Regulation effects of total flavonoids in Morus alba L. on hepatic cholesterol disorders in orotic acid induced NAFLD rats.BMC complementary medicine and therapies · 2020Article
- Berberine Facilitates Extinction of Drug-Associated Behavior and Inhibits Reinstatement of Drug Seeking.Frontiers in pharmacology · 2020Article
- Effectiveness of a Novel Nutraceutical Compound Containing Red Yeast Rice, Polymethoxyflavones and Antioxidants in the Modulation of Cholesterol Levels in Subjects With Hypercholesterolemia and Low-Moderate Cardiovascular Risk: The NIRVANA Study.Frontiers in physiology · 2019Article
- An evaluation of randomized controlled trials on nutraceuticals containing traditional Chinese medicines for diabetes management: a systematic review.Chinese medicine · 2019Review
- Effects of mulberry leaf on experimental hyperlipidemia rats induced by high-fat diet.Experimental and therapeutic medicine · 2018Article
- Cholesterol-Lowering Nutraceuticals Affecting Vascular Function and Cardiovascular Disease Risk.Current cardiology reports · 2018Review
- Effects of a nutraceutical combination of fermented red rice, liposomal berberine, and curcumin on lipid and inflammatory parameters in patients with mild-to-moderate hypercholesterolemia: an 8-week, open-label, single-arm pilot study.Archives of medical sciences. Atherosclerotic diseases · 2018Article
- Different age-independent effects of nutraceutical combinations on endothelium-mediated coronary flow reserve.Immunity & ageing : I & A · 2018Article
- A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIKClinicoEconomics and outcomes research : CEOR · 2018Article
- Effect of a novel nutraceutical combination on serum lipoprotein functional profile and circulating PCSK9.Therapeutics and clinical risk management · 2017Article
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNutraceuticals (NUT) are forms of compounds with biological activity commonly used to improve health in dosage largely exceeding those obtainable in food.
aimWe compared, in a double blind randomized cross-over trial, the effects of two NUT combinations on the control of glico-lipidic metabolism in patients with hypercholesterolemia not on statins.
methodsAt study start patients were given dietary counseling and received placebo for 2 weeks. After this run-in period, patients were randomized: (1) Combination A [Policosanol, Red yeast rice (Monakolin K 3 mg), Berberine 500 mg, Astaxantine, Folic Acid and Coenzyme Q10] for 4 weeks followed by 4 weeks of Combination B [Red yeast rice (Monakolin K 3.3 mg), Berberine 531.25 mg and leaf extract of Morus alba]; (2) Combination B for 4 weeks followed by 4 weeks of Combination A.
resultsCombination B reduced LDL cholesterol below 130 mg/dl in 56.5 % of the patients, and Cambination A only in 21.7 % of them (p ≤ 0.027). Both treatments reduced plasma levels of triglycerides, total and LDL cholesterol and increased HDL cholesterol (all p < 0.03). Total and LDL cholesterol reduction was more pronounced in patients taking Combination B (p < 0.005). Combination B reduced also glycated hemoglobin, fasting glucose and insulin plasma levels as well as HOMA index (p < 0.005).
conclusionsAn increased content of Berberin and Monacolin K and the addition of Morus alba extract improves the effect on plasma cholesterol and on glucose metabolism of the NUT Combination. These effects may allow the speculation of a more marked improvement in cardiovascular prognosis.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.