Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized study
Summary: Background & Aims: Obesity-related mitochondrial dysfunction initiates and exacerbates endothelial dysfunction, which in turn contributes to the development of several diseases, such as cardiovascular disease and cognitive impairment. Urolithin A (UroA) is a polyphenol-derived micr...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-06-01
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| Series: | Clinical Nutrition Open Science |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2667268525000439 |
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| author | Ana Clara da C. Pinaffi-Langley Camila B. Pinto Zsofia Szarvas Anna Peterfi Zalan Kaposzta Peter Mukli Mihaly Muranyi Cameron D. Owens Cheryl Adams Ali Shahriari Henry Kinnard, Jr. Bryan Ticer Leah Anderson Stefano Tarantini Yan Daniel Zhao Norman G. Hord Andriy Yabluchanskiy |
| author_facet | Ana Clara da C. Pinaffi-Langley Camila B. Pinto Zsofia Szarvas Anna Peterfi Zalan Kaposzta Peter Mukli Mihaly Muranyi Cameron D. Owens Cheryl Adams Ali Shahriari Henry Kinnard, Jr. Bryan Ticer Leah Anderson Stefano Tarantini Yan Daniel Zhao Norman G. Hord Andriy Yabluchanskiy |
| author_sort | Ana Clara da C. Pinaffi-Langley |
| collection | DOAJ |
| description | Summary: Background & Aims: Obesity-related mitochondrial dysfunction initiates and exacerbates endothelial dysfunction, which in turn contributes to the development of several diseases, such as cardiovascular disease and cognitive impairment. Urolithin A (UroA) is a polyphenol-derived microbial metabolite with mitophagy activator activity. Although the safety, pharmacokinetics, and effects of UroA supplementation on muscle health have been investigated in humans, its potential to mitigate endothelial dysfunction in obese adults remains unknown. Thus, this protocol details the procedures of a study designed to investigate the effect of 4 weeks of UroA supplementation on endothelial and cerebrovascular function in middle-aged adults with obesity. Methods: This study is a placebo-controlled, double-blind, randomized, parallel interventional trial. Eligible participants are between 40–64 years old and have a BMI ≥30 kg/m2. Enrolled participants are randomized to receive active (1,000 mg of UroA daily) or control (placebo) intervention for 4 weeks. Before and after the intervention, they undergo peripheral micro- and macrovascular endothelial function and cerebrovascular function assessments. Results: We expect that those who receive UroA supplementation will have a significant improvement in endothelial and cerebrovascular function compared with those who receive placebo. Conclusion: The results of this trial will provide important insights into the effect of UroA on endothelial dysfunction in adults with obesity. Trial registration: This study was prospectively registered at ClinicalTrials.gov on June 26, 2023 (NCT05921266). |
| format | Article |
| id | doaj-art-2909ef3bd6ac42eeb56959790dd3ae21 |
| institution | DOAJ |
| issn | 2667-2685 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Clinical Nutrition Open Science |
| spelling | doaj-art-2909ef3bd6ac42eeb56959790dd3ae212025-08-20T03:19:53ZengElsevierClinical Nutrition Open Science2667-26852025-06-016121723010.1016/j.nutos.2025.04.004Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized studyAna Clara da C. Pinaffi-Langley0Camila B. Pinto1Zsofia Szarvas2Anna Peterfi3Zalan Kaposzta4Peter Mukli5Mihaly Muranyi6Cameron D. Owens7Cheryl Adams8Ali Shahriari9Henry Kinnard, Jr.10Bryan Ticer11Leah Anderson12Stefano Tarantini13Yan Daniel Zhao14Norman G. Hord15Andriy Yabluchanskiy16Oklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Department of Nutritional Sciences, College of Allied Health, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Vascular Cognitive Impairment and Neurodegeneration Program, Department of Neurosurgery, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Vascular Cognitive Impairment and Neurodegeneration Program, Department of Neurosurgery, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Vascular Cognitive Impairment and Neurodegeneration Program, Department of Neurosurgery, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Vascular Cognitive Impairment and Neurodegeneration Program, Department of Neurosurgery, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Vascular Cognitive Impairment and Neurodegeneration Program, Department of Neurosurgery, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Vascular Cognitive Impairment and Neurodegeneration Program, Department of Neurosurgery, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Vascular Cognitive Impairment and Neurodegeneration Program, Department of Neurosurgery, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Shared Clinical and Translational Resources, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Shared Clinical and Translational Resources, University of Oklahoma Health Sciences, Oklahoma City, OK, USA1893 Pharmacy, College of Pharmacy, University of Oklahoma Health Sciences, Oklahoma City, OK, USA1893 Pharmacy, College of Pharmacy, University of Oklahoma Health Sciences, Oklahoma City, OK, USADepartment of Nutritional Sciences, College of Allied Health, University of Oklahoma Health Sciences, Oklahoma City, OK, USAOklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Vascular Cognitive Impairment and Neurodegeneration Program, Department of Neurosurgery, University of Oklahoma Health Sciences, Oklahoma City, OK, USADepartment of Biostatistics & Epidemiology, College of Public Health, University of Oklahoma Health Sciences, Oklahoma City, OK, USADepartment of Nutritional Sciences, College of Education and Human Sciences, Oklahoma State University, Stillwater, OK, USAOklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Vascular Cognitive Impairment and Neurodegeneration Program, Department of Neurosurgery, University of Oklahoma Health Sciences, Oklahoma City, OK, USA; Corresponding author. Oklahoma Center for Geroscience and Healthy Brain Aging, University of Oklahoma Health Sciences, Oklahoma City, OK, USASummary: Background & Aims: Obesity-related mitochondrial dysfunction initiates and exacerbates endothelial dysfunction, which in turn contributes to the development of several diseases, such as cardiovascular disease and cognitive impairment. Urolithin A (UroA) is a polyphenol-derived microbial metabolite with mitophagy activator activity. Although the safety, pharmacokinetics, and effects of UroA supplementation on muscle health have been investigated in humans, its potential to mitigate endothelial dysfunction in obese adults remains unknown. Thus, this protocol details the procedures of a study designed to investigate the effect of 4 weeks of UroA supplementation on endothelial and cerebrovascular function in middle-aged adults with obesity. Methods: This study is a placebo-controlled, double-blind, randomized, parallel interventional trial. Eligible participants are between 40–64 years old and have a BMI ≥30 kg/m2. Enrolled participants are randomized to receive active (1,000 mg of UroA daily) or control (placebo) intervention for 4 weeks. Before and after the intervention, they undergo peripheral micro- and macrovascular endothelial function and cerebrovascular function assessments. Results: We expect that those who receive UroA supplementation will have a significant improvement in endothelial and cerebrovascular function compared with those who receive placebo. Conclusion: The results of this trial will provide important insights into the effect of UroA on endothelial dysfunction in adults with obesity. Trial registration: This study was prospectively registered at ClinicalTrials.gov on June 26, 2023 (NCT05921266).http://www.sciencedirect.com/science/article/pii/S2667268525000439Endothelial functionObesityPolyphenolsDietary supplementEllagitanninsMicrobial metabolites |
| spellingShingle | Ana Clara da C. Pinaffi-Langley Camila B. Pinto Zsofia Szarvas Anna Peterfi Zalan Kaposzta Peter Mukli Mihaly Muranyi Cameron D. Owens Cheryl Adams Ali Shahriari Henry Kinnard, Jr. Bryan Ticer Leah Anderson Stefano Tarantini Yan Daniel Zhao Norman G. Hord Andriy Yabluchanskiy Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized study Clinical Nutrition Open Science Endothelial function Obesity Polyphenols Dietary supplement Ellagitannins Microbial metabolites |
| title | Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized study |
| title_full | Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized study |
| title_fullStr | Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized study |
| title_full_unstemmed | Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized study |
| title_short | Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized study |
| title_sort | urolithin a supplementation to improve endothelial and cerebrovascular function in middle aged adults with obesity study protocol for a double blind placebo controlled randomized study |
| topic | Endothelial function Obesity Polyphenols Dietary supplement Ellagitannins Microbial metabolites |
| url | http://www.sciencedirect.com/science/article/pii/S2667268525000439 |
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