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"Clinical trial"

Original Articles
[English]
The Effects of Coenzyme Q10 Supplementation on Oxidative Status and Lipid Profile in Migraine Patients: A Randomized Double-Blinded Controlled Clinical Trial
Monireh Dahri, Atefeh Sarafan Sadeghi, Naseh Pahlavani, Elyas Nattagh-Eshtivani, Mazyar Hashemilar, Mohammad Asghari-Jafarabadi, Hanieh Barghchi, Ali Tarighat-Esfanjani
Clin Nutr Res 2023;12(4):257-268.   Published online October 31, 2023
DOI: https://doi.org/10.7762/cnr.2023.12.4.257

Migraine is a common neurological disease correlated with oxidative stress and lipid profile disorders. The present study was designed to determine the effects of Coenzyme Q10 (Co-Q10) supplementation on oxidative status and lipid profile in migraine individuals. This clinical trial was conducted on 84 females aged 18–50 years, diagnosed for episodic migraine according to the International Headache Society. Subjects were randomized to receive either Co-Q10 supplement (400 mg/day) or placebo for 12 weeks. Lipid profile and oxidative stress indices including malondialdehyde (MDA) and total antioxidant capacity (TAC) were measured before and after intervention in both groups. Also, anthropometric indices, dietary intakes, and clinical features were collected. Data analysis was conducted using SPSS version 16. Seventy-seven of the participants, with mean age of 33.70 ± 7.75 years, completed the study. After 12-week intervention, Co-Q10 led to a significant decrease in MDA levels compared to placebo (p = 0.009), with no effect on TAC levels (p = 0.106). A significant increase in serum Co-Q10 concentration and high-density lipoprotein cholesterol (HDL-C) level in Co-Q10 group was observed, but no significant differences were found in other lipid profile variables (low-density lipoprotein cholesterol, triglycerides and total cholesterol). Among anthropometric variables, Co-Q10 only caused a significant reduction in body fat percentage (BFP), but we did not find any significant changes in others. A 12-week Co-Q10 supplementation led to significant improvement in clinical features, BFP, and HDL-C level among migraine individuals.

Trial Registration

Iranian Registry of Clinical Trials Identifier: IRCT201508265670N10

Citations

Citations to this article as recorded by  
  • Bridging Gaps in Migraine Management: A Comprehensive Review of Conventional Treatments, Natural Supplements, Complementary Therapies, and Lifestyle Modifications
    Fatma Abo-Elghiet, Heba Elosaily, Doha K. Hussein, Riham A. El-Shiekh, Ashraf A’aqoulah, Einas M. Yousef, Heba Mohammed Refat M. Selim, Ahmed M. El-Dessouki
    Pharmaceuticals.2025; 18(2): 139.     CrossRef
  • The protective effects of coenzyme Q10 on blood pressure: a narrative review of anti-inflammatory and antioxidant mechanisms
    Seyed Mohammad Hosseini Roknabadi, Amirmohammad Abolhassani, Erfan Davoodi, Fatemeh Zahra Moghaddam Rad, Sadegh Jafarnejad
    Inflammopharmacology.2025; 33(9): 5191.     CrossRef
  • Evaluating the Role of Coenzyme Q10 in Migraine Therapy—A Narrative Review
    Anna Fajkiel-Madajczyk, Michał Wiciński, Zuzanna Kurant, Józef Sławatycki, Maciej Słupski
    Antioxidants.2025; 14(3): 318.     CrossRef
  • Effects of grape seed extract supplementation on inflammatory biomarkers, oxidative stress, clinical symptoms, and quality of life in patients with migraine: A double-blinded randomized placebo-controlled clinical trial
    Niloofar Eshaghian, Omid Sadeghi, Aliakbar Foroghi, Fariborz Khorvash, Gholamreza Askari
    Journal of Research in Medical Sciences.2025;[Epub]     CrossRef
  • Sexual Dimorphism in Migraine. Focus on Mitochondria
    Michal Fila, Lukasz Przyslo, Marcin Derwich, Elzbieta Pawlowska, Janusz Blasiak
    Current Pain and Headache Reports.2025;[Epub]     CrossRef
  • Practical supplements for prevention and management of migraine attacks: a narrative review
    Zahra Hajhashemy, Sahar Golpour-Hamedani, Niloofar Eshaghian, Omid Sadeghi, Fariborz Khorvash, Gholamreza Askari
    Frontiers in Nutrition.2024;[Epub]     CrossRef
  • The effect of coenzyme Q10 intake on metabolic profiles in women candidates for in-vitro fertilization: a randomised trial
    Sahar Ahmadi Asouri, Reza Asemi, Esmat Aghadavod, Mehri Jamilian
    Annals of Medicine & Surgery.2024; 86(6): 3378.     CrossRef
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[English]

The aim of this systematic review and meta-analysis was to summarize all the existing randomized controlled trials (RCTs) evidence and to evaluate the effects of magnesium supplementation on serum magnesium, calcium and urinary magnesium concentrations in patients with type 2 diabetes compared with the control. Two independent authors systematically searched online databases including Embase, Scopus, PubMed, and Web of Science from inception until 30th January 2022. RCTs complying with the inclusion criteria were included in this meta-analysis. The heterogeneity among the included studies was assessed using Cochrane’s Q test and I-square (I2) statistic. Data were pooled using a random-effects model and weighted mean difference (WMD) was considered as the overall effect size. Sixteen trials were included in this meta-analysis. Serum magnesium (mean difference, 0.15 mg/dL; 95% confidence interval [CI], 0.06 to 0.23; p = 0.001) and urinary magnesium (WMD, 1.99 mg/dL; 95% CI, 0.36 to 3.62; p = 0.017) concentrations were significantly increased after magnesium supplementation when compared with the control group. However, magnesium supplementation did not have any significant effect on serum calcium (WMD, −0.09 mg/dL; 95% CI, −0.27 to 0.08; p = 0.294) level when compared with the control group. This meta-analysis demonstrated that magnesium supplementation significantly increased Serum magnesium levels which may have played an indirect role in improved clinical symptoms in patients with type 2 diabetes.

Citations

Citations to this article as recorded by  
  • Role of Zinc and Magnesium in Glycemic Status Among the Saudi Population
    Norah Almajed, Sara Al-Musharaf, Madhawi Aldhwayan, Tagreed Mazi, Salem AlShammari, Fatima Almadani, Ghadeer Aljuraiban
    International Journal of General Medicine.2025; Volume 18: 7627.     CrossRef
  • Oral magnesium supplementation does not affect insulin sensitivity in people with insulin-treated type 2 diabetes and a low serum magnesium: a randomised controlled trial
    Linda C. A. Drenthen, Jeroen H. F. de Baaij, Laura Rodwell, Antonius E. van Herwaarden, Cees J. Tack, Bastiaan E. de Galan
    Diabetologia.2024; 67(1): 52.     CrossRef
  • The Association of Serum and Dietary Magnesium with Depressive Symptoms
    Ming-Hui Chou, Yen Kuang Yang, Jung-Der Wang, Chung-Ying Lin, Sheng-Hsiang Lin
    Nutrients.2023; 15(3): 774.     CrossRef
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[English]
The Effect of Nutrition Education Program on Overweight/Obese Patients with Non-Alcoholic Fatty Liver Disease: a Single-Blind Parallel Randomized Controlled Trial
Arman Arab, Amir Hadi, Seyedeh Parisa Moosavian, Nahid Rafie, Hossein Hajianfar
Clin Nutr Res 2019;8(3):238-246.   Published online July 29, 2019
DOI: https://doi.org/10.7762/cnr.2019.8.3.238

The aim of this study was to assess the effects of a nutrition education program on overweight/obese patients with non-alcoholic fatty liver disease (NAFLD). This single-blind, parallel randomized controlled trial was conducted on 82 NAFLD patients (mean age 48.89 ± 9.85 years) in Isfahan, Iran. Patients were randomly allocated to receive nutrition education program combined with usual care or usual care alone for 2 months. Metabolic markers, including lipid profile, fasting blood glucose (FBG) and dietary intakes were obtained for each patient at baseline and at the end of the study. Nutrition education intervention resulted in a significant decrease compared with usual care in serum levels of total cholesterol (TC) and triglyceride (TG) (p < 0.05). However, our intervention did not lead to a significant improvement in FBG, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), respectively (p > 0.05). Furthermore, energy and sugar intakes of patients were reduced significantly in response to our intervention (p < 0.05). Nutrition education intervention significantly reduced serum levels of TC and TG but did not affect other metabolic markers including FBG, LDL-C, and HDL-C. Also, it could reduce total energy and sugar intake. Thus, this study could be useful to use this educational program for NAFLD patients in order to influence their metabolic markers and dietary intakes.

Trial Registration

IRCT Identifier: IRCT2014101811763N17

Citations

Citations to this article as recorded by  
  • Non‐alcoholic fatty liver disease: The importance of physical activity and nutrition education—A randomized controlled study
    Diler Us Altay, Yasemin Kaya, Duygu Mataraci Değirmenci, Emine Kocyiğit, Abdullah Üner, Tevfik Noyan
    Journal of Gastroenterology and Hepatology.2024; 39(12): 2723.     CrossRef
  • Circulating lipoprotein(a) in patients with nonalcoholic fatty liver disease: a systematic review and meta‐analysis
    Aikaterini Nikoli, Myrsini Orfanidou, Antonis Goulas, Dimitrios G. Goulis, Stergios A. Polyzos
    Journal of Gastroenterology and Hepatology.2024; 39(12): 2572.     CrossRef
  • Behavioral weight-loss interventions for patients with NAFLD: A systematic scoping review
    Maya Balakrishnan, Kyle Liu, Sydney Schmitt, Natalia I. Heredia, Amy Sisson, Jane R. Montealegre, Ruben Hernaez, Fasiha Kanwal, John Foreyt
    Hepatology Communications.2023;[Epub]     CrossRef
  • A Scoping Review of Epidemiological Studies on Intake of Sugars in Geographically Dispersed Asian Countries: Comparison of Dietary Assessment Methodology
    Aya Fujiwara, Yuka Omura, Fumi Oono, Minami Sugimoto, Satoshi Sasaki, Hidemi Takimoto
    Advances in Nutrition.2022; 13(5): 1947.     CrossRef
  • Dietary Interventions in Liver Diseases: Focus on MAFLD and Cirrhosis
    Élise Vuille-Lessard, Naomi Lange, Carlotta Riebensahm, Jean-François Dufour, Annalisa Berzigotti
    Current Hepatology Reports.2021; 20(2): 61.     CrossRef
  • The Effects of Foods on Blood Lipids in Non-alcoholic Fatty Liver Disease (NAFLD)—A Systematic Review and Meta-Analysis
    Fredrik Rosqvist, Andreas Rydell, David Iggman
    Frontiers in Nutrition.2020;[Epub]     CrossRef
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[English]

Korean red ginseng (steam treated Panax ginseng C.A. Meyer), among most prized traditional herbal remedies, has been clinically shown to improve cardiovascular disease (CVD) risk factors. Whether this holds true for the dried non-steamed variety, known as Korean white ginseng (KWG) is unclear. This study therefore, investigated the efficacy and safety of escalating doses of KWG on vascular and glycemic parameters in type 2 diabetes (T2DM). Using an acute, randomized, placebo-controlled, double-blind, crossover design, 25 participants with well-controlled T2DM (12-males: 13-females, age: 63 ± 9 years, A1c: 6.9 ± 0.7%, BMI: 29.3 ± 4.3 kg/m2) underwent five visits during which they received 1 g, 3 g, or 6 g KWG or 3 g wheat-bran control (twice) together with 50 g-glucose load. For the duration of 240 minutes, augmentation index (AI), and central blood pressure were measured at baseline and at 60 min-intervals, and ambulatory blood pressure was assessed at baseline and at 10 min-intervals. Additionally, capillary blood was collected at time zero and at 15, 30, 45, 60, 90, 120, and 180 minutes post-treatment. A symptoms questionnaire was used to assess safety and adverse events. Two-way ANOVA demonstrated a significant time-treatment interaction effect on AI (p = 0.01) with one-way ANOVA showing significant reductions in AI with 3 g KWG relative to control (p = 0.04). Compared to control, acute administration of KWG appeared to be safe, but did not affect any other postprandial, vascular or glycemic parameters. KWG might have a beneficial effect on AI, a cumulative indicator of arterial health. However, these results are preliminary and highlight the need for long-term investigation with a focus on its accountable components. Clinical Trial Registration: NCT01699074

Citations

Citations to this article as recorded by  
  • Therapeutic Potential of Ginsenosides in Anthracycline-Induced Cardiotoxicity
    Rongrong Bai, Zhigao Zhao, Xing Han, Mingying Shang, Guangxue Liu, Feng Xu, Shaoqing Cai
    Molecules.2025; 30(12): 2527.     CrossRef
  • Ginseng supplementation and vascular function: a systematic review and meta-analysis of clinical trials
    Ayda Esmaeili, Naser Khalili, Nastaran Najafi, Fatemeh Hajizadeh-Sharafabad
    BMC Complementary Medicine and Therapies.2025;[Epub]     CrossRef
  • A systemic review of ginseng and its activity on coronary heart disease
    Shivam Alpeshkumar Parmar, Vinyas Mayasa, Vinod Kumar Nelson, Jhanvi Divecha
    Pharmacological Research - Modern Chinese Medicine.2024; 12: 100480.     CrossRef
  • Ginsenoside Rd attenuated hyperglycemia via Akt pathway and modulated gut microbiota in streptozotocin-induced diabetic rats
    Wei Wang, Fengtao Guan, Gianni Sagratini, Jie Yan, Jiahan Xie, Zhibo Jin, Meihong Liu, Huimin Liu, Jingsheng Liu
    Current Research in Food Science.2023; 6: 100491.     CrossRef
  • The Efficacy of Ginseng (Panax) on Human Prediabetes and Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis
    Kaveh Naseri, Saeede Saadati, Amir Sadeghi, Omid Asbaghi, Fatemeh Ghaemi, Fatemeh Zafarani, Hua-Bin Li, Ren-You Gan
    Nutrients.2022; 14(12): 2401.     CrossRef
  • Anti-Diabetic Effects of Isolated Lipids from Natural Sources through Modulation of Angiogenesis
    Soraya Sajadimajd, Mina Khosravifar, Gholamreza Bahrami
    Current Molecular Pharmacology.2022; 15(4): 589.     CrossRef
  • Studies on Bioactive Components of Red Ginseng by UHPLC-MS and Its Effect on Lipid Metabolism of Type 2 Diabetes Mellitus
    Rensong Huang, Meng Zhang, Yu Tong, Yaran Teng, Hui Li, Wei Wu
    Frontiers in Nutrition.2022;[Epub]     CrossRef
  • The role of selected nutraceuticals in management of prediabetes and diabetes: An updated review of the literature
    Giuseppe Derosa, Angela D'Angelo, Pamela Maffioli
    Phytotherapy Research.2022; 36(10): 3709.     CrossRef
  • Ginsenosides for cardiovascular diseases; update on pre-clinical and clinical evidence, pharmacological effects and the mechanisms of action
    Michael Sarhene, Jing Yu Ni, Esi Sophia Duncan, Zhihao Liu, Sheng Li, Jing Zhang, Rui Guo, Shan Gao, Xiumei Gao, Guanwei Fan
    Pharmacological Research.2021; 166: 105481.     CrossRef
  • The Effects of New Zealand Grown Ginseng Fractions on Cytokine Production from Human Monocytic THP-1 Cells
    Wei Chen, Prabhu Balan, David G. Popovich
    Molecules.2021; 26(4): 1158.     CrossRef
  • A comprehensive review on the phytochemistry, pharmacokinetics, and antidiabetic effect of Ginseng
    Yage Liu, Hao Zhang, Xuan Dai, Ruyuan Zhu, Beibei Chen, Bingke Xia, Zimengwei Ye, Dandan Zhao, Sihua Gao, Alexander N. Orekhov, Dongwei Zhang, Lili Wang, Shuzhen Guo
    Phytomedicine.2021; 92: 153717.     CrossRef
  • Herbal Medicine for Slowing Aging and Aging-associated Conditions: Efficacy, Mechanisms and Safety
    Hoa T. Phu, Duong T.B. Thuan, Thi H.D. Nguyen, Anna M. Posadino, Ali H. Eid, Gianfranco Pintus
    Current Vascular Pharmacology.2020; 18(4): 369.     CrossRef
  • Herbal Medicine for Cardiovascular Diseases: Efficacy, Mechanisms, and Safety
    Abdullah Shaito, Duong Thi Bich Thuan, Hoa Thi Phu, Thi Hieu Dung Nguyen, Hiba Hasan, Sarah Halabi, Samar Abdelhady, Gheyath K. Nasrallah, Ali H. Eid, Gianfranco Pintus
    Frontiers in Pharmacology.2020;[Epub]     CrossRef
  • The Anticancer Activity and Mechanisms of Ginsenosides: An Updated Review
    Hongwei Chen, Haixia Yang, Daidi Fan, Jianjun Deng
    eFood.2020; 1(3): 226.     CrossRef
  • De�novo transcriptome analysis of gene responses to pest feeding in leaves of Panax�ginseng C. A. Meyer
    Guangsheng Xi, Yanling Wang, Le Yin, Yunjia Wang, Shengxue Zhou
    Molecular Medicine Reports.2019;[Epub]     CrossRef
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    Wei Chen, Prabhu Balan, David G. Popovich
    Molecules.2019; 24(24): 4501.     CrossRef
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    Morris Karmazyn, Xiaohong Tracey Gan
    Canadian Journal of Physiology and Pharmacology.2019; 97(4): 265.     CrossRef
  • Ginsenoside Rg3 stereoisomers differentially inhibit vascular smooth muscle cell proliferation and migration in diabetic atherosclerosis
    Mengqi Guo, Guanlun Guo, Jie Xiao, Xi Sheng, Xinyu Zhang, Yuanyuan Tie, Yuen‐Kit Cheng, Xiaoping Ji
    Journal of Cellular and Molecular Medicine.2018; 22(6): 3202.     CrossRef
  • Synergistic effect of combined protopanaxatiol and ginsenoside Rh2 on antiproliferative activity in MDA-MB-231 human breast cancer cells in vitro
    Guixing Ren, Caie Wu, Cong Teng, Yang Yao
    Food and Agricultural Immunology.2018; 29(1): 953.     CrossRef
  • Cardiovascular disease risk reduction in diabetes through conventional and natural approaches
    William M. Schultz, Elliot N. Mahlof, Devinder S. Dhindsa, Tina Varghese, Robert E. Heinl, Hannah C. Cai, Pratik B. Sandesara, Danny J. Eapen, Laurence S. Sperling
    Cardiovascular Endocrinology.2017; 6(4): 128.     CrossRef
  • Protopanaxadiol and Protopanaxatriol-Type Saponins Ameliorate Glucose and Lipid Metabolism in Type 2 Diabetes Mellitus in High-Fat Diet/Streptozocin-Induced Mice
    Jianjun Deng, Yao Liu, Zhiguang Duan, Chenhui Zhu, Junfeng Hui, Yu Mi, Pei Ma, Xiaoxuan Ma, Daidi Fan, Haixia Yang
    Frontiers in Pharmacology.2017;[Epub]     CrossRef
  • Protective and anti-angiopathy effects of ginsenoside Re against diabetes mellitus via the activation of p38 MAPK, ERK1/2 and JNK signaling
    Yawei Shi, Xuesi Wan, Nan Shao, Runyi Ye, Ning Zhang, Yunjian Zhang
    Molecular Medicine Reports.2016; 14(5): 4849.     CrossRef
  • Rapid preparation of rare ginsenosides by acid transformation and their structure-activity relationships against cancer cells
    Kai Quan, Qun Liu, Jin-Yi Wan, Yi-Jing Zhao, Ru-Zhou Guo, Raphael N. Alolga, Ping Li, Lian-Wen Qi
    Scientific Reports.2015;[Epub]     CrossRef
  • Ginsenoside Rg1 improves bone marrow haematopoietic activity via extramedullary haematopoiesis of the spleen
    Hua‐Hsing Liu, Fei‐Peng Chen, Rong‐Kai Liu, Chun‐Lin Lin, Ko‐Tung Chang
    Journal of Cellular and Molecular Medicine.2015; 19(11): 2575.     CrossRef
  • Herbs for Diabetes: Update—Part 1
    Eric Yarnell, Kathy Abascal
    Alternative and Complementary Therapies.2014; 20(6): 328.     CrossRef
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  • 25 Crossref