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Active and completed clinical studies from ClinicalTrials.gov
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Academic studies and reviews for this medicine's active substance
Showing all 28 studies.
Reviews & meta-analyses: 3 · Randomised trials: 1 · 2023–2026
Showing all 28 studies, sorted by most relevant.
Mohammad Reza Amini, Shervin Kazeminejad, Moharam Jalalzadeh, et al.
Diabetes research and clinical practice, 2024
- Blood Glucose
- Fatty Alcohols
- Dietary Supplements
Afsaneh Gholamrezayi, Mohammad Reza Amini, Niloufar Rasaei, et al.
Complementary therapies in medicine, 2024
- Liver
- Dietary Supplements
- Alanine Transaminase
OBJECTIVE: Policosanol is a mixture of long chain alcohols refined from sugar cane. Significant reductions in liver enzymes have been observed in some studies. However, the impact of policosanol on liver enzymes remained controversial. The current meta-analysis aims to evaluate the effect of policosanol supplementation on the levels of alanine transaminase (ALT) and aspartate transaminase (AST). METHODS: The literature was systematically searched for studies published up to November 2023 in PubMed/Medline, Google Scholar, EMBASE, and Scopus. Randomized controlled trial (RCT) studies were included to evaluate the intervention effect of policosanol compared to placebo on ALT and AST. DerSimonian and Laird models were used to calculate effect sizes. RESULTS: Twenty-three trials including 2535 participants were included in the study. The combination of effect sizes, regarding the random-effects model, demonstrated significant changes in ALT serum levels after intervention (WMD: -1.48 U/L; 95% CI: -2.33 to -0.64; P = 0.001), and AST (WMD: -1.10 U/L; 95% CI: -1.70 to -0.51; P < 0.001). Subgroup analysis of AST and ALT showed that this reduction effect was most often observed at the dose of 20 mg/d. The dose-response analysis represented a non-significant non-linear connection between the dosage and duration of policosanol intervention in ALT and AST serum reduction. CONCLUSION: Policosanol supplementation exerts a beneficial effect on liver enzymes as well as ALT and AST concentrations in adults. However, further long-term and well-designed RCTs with better quality are needed to further assess and confirm these results.
Abstract licence: CC BY-NC-ND
Mohammad Reza Amini, Sara Sadeghi Majd, M. Salavatizadeh, et al.
BMC Complementary Medicine and Therapies, 2025
- Antioxidants
- Creatinine
- Fatty Alcohols
Policosanol, a compound generated from sugar cane, consists of alcohols such as octacosanol, hexacosanol, and triacontanol, which possess antioxidant properties. Evaluating the impact of this antioxidant on serum creatinine in clinical settings is essential because of the contradictory findings. This comprehensive review and dose–response meta-analysis attempts to evaluate the impact of policosanol supplementation on creatinine levels. A comprehensive search was performed in bibliographic databases such as Cochrane, PubMed, Google Scholar, Scopus, and Web of Science, covering the period from inception to November 2023. The necessary data was retrieved, and pertinent randomized controlled trials (RCTs) that satisfied the inclusion criteria were included. Weighted mean differences (WMDs) were the reported measure of the pooled effects. To find between-study heterogeneities, the I-squared test was employed. A total of 2427 participants were involved in the twenty-one RCTs that were included. A meta-analysis showed that policosanol had no significant change in creatinine levels in participants consuming policosanol compared to placebo consumers (WMD = 0.21 µmol/l; 95% CI = − 0.85 to 1.26; P = 0.70). Policosanol consumption for durations ≥ 24 weeks significantly decreased creatinine, according to subgroup studies. There was a non-linear correlation between changes in creatinine levels and the dosage of prescription policosanol (P non_linearity = 0.002). However, the treatment time did not have a significant impact on creatinine levels in a non-linear manner (P non_linearity = 0.24). Policosanol supplementation has no significant effect on creatinine levels.
Abstract licence: CC BY-NC-ND
K. Cho, H. Nam, Seung-hee Baek, et al.
International Journal of Molecular Sciences, 2023
- Anticholesteremic Agents
- Lipoproteins, HDL
- East Asian People
This study evaluated the efficacy and safety of 20 mg of Cuban policosanol in blood pressure (BP) and lipid/lipoprotein parameters of healthy Japanese subjects via a placebo-controlled, randomized, and double-blinded human trial. After 12 weeks of consumption, the policosanol group showed significantly lower BP, glycated hemoglobin (HbA1c), and blood urea nitrogen (BUN) levels. The policosanol group also showed lower aspartate aminotransferase (AST), alanine aminotransferase (ALT), and γ-glutamyl transferase (γ-GTP) levels at week 12 than those at week 0: A decrease of up to 9% (p < 0.05), 17% (p < 0.05), and 15% (p < 0.05) was observed, respectively. The policosanol group showed significantly higher HDL-C level and HDL-C/TC (%), approximately 9.5% (p < 0.001) and 7.2% (p = 0.003), respectively, than the placebo group and a difference in the point of time and group interaction (p < 0.001). In lipoprotein analysis, the policosanol group showed a decrease in oxidation and glycation extent in VLDL and LDL with an improvement of particle shape and morphology after 12 weeks. HDL from the policosanol group showed in vitro stronger antioxidant and in vivo anti-inflammatory abilities. In conclusion, 12 weeks of Cuban policosanolconsumption in Japanese subjects showed significant improvement in blood pressure, lipid profiles, hepatic functions, and HbA1c with enhancement of HDL functionalities.
Abstract licence: CC BY
E. Bruno, F. R. Lupi, D. Mammolenti, et al.
Food Hydrocolloids, 2024
Bigels are composite materials made by two phases with different polarities (i.e., an oleogel and a hydrogel) mixed between them without the addition of emulsifiers. Owing to their versatile rheological properties, they can be used for designing new products for food industry, or for cosmetics and pharmaceutical applications. In the past, different models have been proposed to relate their rheological properties to single phases characteristics and volume fraction. This paper proposes the rheological characterization and modeling of bigels prepared with citrus fiber particle gels (as the aqueous phase) and policosanol-based oleogels by investigating the effects of the ratio between rheological properties of phases and of the dispersed phase volume fraction. Both components (i.e., citrus fiber and policosanol) exhibit interesting properties for preparing plant-based healthy foodstuffs. Rheological characterization was carried out revealing that O/W bigels were formed at low fractions of oleogel added to gelled suspension whereas, at higher fractions, a transition throughout a matrix-in-matrix systems and, finally, a phase inversion occurred. The trend of phase angle at 1 Hz with oleogel volume fraction was used as a criterion to highlight the phase transition, as confirmed by confocal microscopy. Two models were proposed for predicting the rheological behavior of samples with both phase arrangements.
Abstract licence: CC BY
K. Cho, H. Nam, N. Kim, et al.
Pharmaceuticals, 2024
Obesity and overweight, frequently caused by a lack of exercise, are associated with many metabolic diseases, such as hypertension, diabetes, and dyslipidemia. Aerobic exercise effectively increases the high-density lipoproteins-cholesterol (HDL-C) levels and alleviates the triglyceride (TG) levels. The consumption of Cuban policosanol (Raydel®) is also effective in enhancing the HDL-C quantity and HDL functionality to treat dyslipidemia and hypertension. On the other hand, no study has examined the effects of a combination of high-intensity exercise and policosanol consumption in obese subjects to improve metabolic disorders. In the current study, 17 obese subjects (average BMI 30.1 ± 1.1 kg/m2, eight male and nine female) were recruited to participate in a program combining exercise and policosanol (20 mg) consumption for 12 weeks. After completion, their BMI, waist circumference, total fat mass, systolic blood pressure (SBP), and diastolic blood pressure (DBP) reduced significantly up to around −15%, −13%, −33%, −11%, and −13%, respectively. In the serum lipid profile, at Week 12, a significant reduction was observed in the total cholesterol (TC) and triglyceride (TG) levels, up to −17% and −54% from the baseline, respectively. The serum HDL-C was elevated by approximately +12% from the baseline, as well as the percentage of HDL-C in TC, and HDL-C/TC (%), was enhanced by up to +32% at Week 12. The serum coenzyme Q10 (CoQ10) level was increased 1.2-fold from the baseline in all participants at Week 12. In particular, the male participants exhibited a 1.4-fold increase from the baseline. The larger rise in serum CoQ10 was correlated with the larger increase in the serum HDL-C (r = 0.621, p = 0.018). The hepatic function parameters were improved; the serum γ-glutamyl transferase decreased at Week 12 by up to −55% (p < 0.007), while the aspartate aminotransferase and alanine transaminase levels diminished within the normal range. In the lipoprotein level, the extent of oxidation and glycation were reduced significantly with the reduction in TG content. The antioxidant abilities of HDL, such as paraoxonase (PON) and ferric ion reduction ability (FRA), were enhanced significantly by up to 1.8-fold and 1.6-fold at Week 12. The particle size and number of HDL were elevated up to +10% during the 12 weeks, with a remarkable decline in the TG content, glycation extent, and oxidation. The improvements in HDL quality and functionality were linked to the higher survivability of adult zebrafish and their embryos, under the co-presence of carboxymethyllysine (CML), a pro-inflammatory molecule known to cause acute death. In conclusion, 12 weeks of Cuban policosanol (Raydel®, 20 mg) consumption with high-intensity exercise displayed a significant improvement in blood pressure, body fat mass, blood lipid profile without liver damage, CoQ10 metabolism, and renal impairment.
Abstract licence: CC BY
Y. Uehara, Tomohiro Komatsu, Kei Sasaki, et al.
Frontiers in Nutrition, 2024
Policosanol supplementation has been reported to increase high-density lipoprotein (HDL)-cholesterol (HDL-C). However, the association between Cuban policosanol supplementation and HDL cholesterol efflux capacity (CEC), an important function of HDL, remains unclear. We performed a lipoprotein analysis investigating 32 Japanese healthy participants (placebo, n = 17 or policosanol supplementation for 12 weeks, n = 15) from a randomized Cuban policosanol clinical trial. First, HDL CEC and HDL-related factors were measured before and after policosanol supplementation. Then, through electron microscopy after ultracentrifugation and high-performance liquid chromatography, HDL morphology and subclass were analyzed, respectively. Finally, the effects of policosanol supplementation regarding HDL function, HDL-related factors, and HDL morphology/component were examined. Cuban policosanol considerably increased the HDL CEC and HDL-C and apolipoprotein A-I (ApoA-I) levels. Furthermore, policosanol supplementation led to larger HDL particles, increased cholesterol content in larger HDL particles, and reduced triglyceride content in smaller HDL particles. In participants with high baseline HDL-C levels, the policosanol effects for HDL CEC are observed. HDL CEC fluctuation induced by policosanol was highly associated with HDL-C and ApoA-I changes. In conclusion, for the first time, we demonstrated that policosanol supplementation increased the HDL CEC in healthy participants.
Abstract licence: CC BY
K. Cho, Ji-Eun Kim, Tomohiro Komatsu, et al.
Life, 2023
Policosanol consumption has been associated with treating blood pressure and dyslipidemia by increasing the level of high-density lipoproteins-cholesterol (HDL-C) and HDL functionality. Although policosanol supplementation also ameliorated liver function in animal models, it has not been reported in a human clinical study, particularly with a 20 mg doage of policosanol. In the current study, twelve-week consumption of Cuban policosanol (Raydel®) significantly enhanced the hepatic functions, showing remarkable decreases in hepatic enzymes, blood urea nitrogen, and glycated hemoglobin. From the human trial with Japanese participants, the policosanol group (n = 26, male 13/female 13) showed a remarkable decrease in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline up to 21% (p = 0.041) and 8.7% (p = 0.017), respectively. In contrast, the placebo group (n = 26, male 13/female 13) showed almost no change or slight elevation. The policosanol group showed a 16% decrease in γ-glutamyl transferase (γ-GTP) at week 12 from the baseline (p = 0.015), while the placebo group showed a 1.2% increase. The policosanol group exhibited significantly lower serum alkaline phosphatase (ALP) levels at week 8 (p = 0.012), week 12 (p = 0.012), and after 4-weeks (p = 0.006) compared to those of the placebo group. After 12 weeks of policosanol consumption, the ferric ion reduction ability and paraoxonase of serum were elevated by 37% (p < 0.001) and 29% (p = 0.004) higher than week 0, while placebo consumption showed no notable changes. Interestingly, glycated hemoglobin (HbA1c) in serum was lowered significantly in the policosanol group 4 weeks after consumption, which was approximately 2.1% (p = 0.004) lower than the placebo group. In addition, blood urea nitrogen (BUN) and uric acid levels were significantly lower in the policosanol group after 4 weeks: 14% lower (p = 0.002) and 4% lower (p = 0.048) than those of the placebo group, respectively. Repeated measures of ANOVA showed that the policosanol group had remarkable decreases in AST (p = 0.041), ALT (p = 0.008), γ-GTP (p = 0.016), ALP (p = 0.003), HbA1c (p = 0.010), BUN (p = 0.030), and SBP (p = 0.011) from the changes in the placebo group in point of time and group interaction. In conclusion, 12 weeks of 20 mg consumption of policosanol significantly enhanced hepatic protection by lowering the serum AST, ALT, ALP, and γ-GTP via a decrease in glycated hemoglobin, uric acid, and BUN with an elevation of serum antioxidant abilities. These results suggest that improvements in blood pressure by consumption of 20 mg of policosanol (Raydel®) were accompanied by protection of liver function and enhanced kidney function.
Abstract licence: CC BY
Samane Safari, N. Mirazi, N. Ahmadi, et al.
Molecular Neurobiology, 2023
- Alzheimer Disease
- Antioxidants
- Disease Models, Animal
Vincenzo Russo, N. Napolitano, Antonia Ascrizzi, et al.
Pharmaceuticals, 2024
Background: Cardiovascular disease is a global health concern and reducing plasma LDL-C levels is a major goal in cardiovascular prevention. Our study aimed to evaluate the effectiveness of a nutraceutical formulation including leucoselect® phytosome®, red yeast rice, policosanol and folic acid on LDL-c levels in patients at low cardiovascular risk with dyslipidemia. Materials and Methods: We prospectively enrolled all consecutive patients with dyslipidemia at low cardiovascular risk who were unresponsive to diet and physical activity. Clinical assessments and laboratory analyses, encompassing lipid profile, hepatic function, and CPK levels, were performed at baseline prior to initiating treatment and repeated at the 12-week mark following administration of the study nutraceutical. Results: Sixty (60) consecutive patients (mean age 48.02 ± 10.1 years; 60% male) were included. At the 12-week follow-up, a statistically significant reduction in Total Cholesterol (13.1%) and LDL-c serum level (20.4%) was observed. Hepatic and muscular function remain stable over the time. The adherence to therapy was 99% and the persistence was maximum. Conclusions: The nutraceutical formulation including leucoselect® phytosome® red yeast rice, policosanol and folic acid significantly reduced the LDL-c plasma levels, consistent with previous research showing that the bioactive component in red yeast rice—lovastatin—is effective in addressing problems with lipid metabolism. Importantly, it was safe and well-tolerated among patients with dyslipidemia in a real-world setting.
Abstract licence: CC BY
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
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