Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trial
Introduction Peri-trochanteric fractures, common among the elderly with osteoporosis, pose significant morbidity and mortality risks. These fractures are increasing due to the ageing population, with Nordic countries seeing a high incidence. They present challenges for orthopaedic surgeons and can l...
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| Format: | Article |
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BMJ Publishing Group
2024-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/12/e092092.full |
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| author | Amirhossein Sahebkar Hoda Zahedi Mohammad-Reza Jowshan Reza Zandi Alireza Tavallaei Zavareh Amir Mehrvar Bahareh Nikooyeh Shahin Talebi |
| author_facet | Amirhossein Sahebkar Hoda Zahedi Mohammad-Reza Jowshan Reza Zandi Alireza Tavallaei Zavareh Amir Mehrvar Bahareh Nikooyeh Shahin Talebi |
| author_sort | Amirhossein Sahebkar |
| collection | DOAJ |
| description | Introduction Peri-trochanteric fractures, common among the elderly with osteoporosis, pose significant morbidity and mortality risks. These fractures are increasing due to the ageing population, with Nordic countries seeing a high incidence. They present challenges for orthopaedic surgeons and can lead to functional decline and high medical costs. Hip fractures have severe consequences, including pain, immobility and increased mortality. Managing wound care is complex, involving various healing phases. Trehalose, a disaccharide with antioxidant and anti-inflammatory properties, has shown promise in wound healing and other health conditions. Studies suggest its potential benefits in reducing inflammation and aiding wound healing in peri-trochanteric fracture patients, but more research is needed to confirm its clinical effectiveness in humans.Methods and analysis The study is a double-blind, placebo-controlled randomised clinical trial aiming to evaluate the effect of trehalose consumption on patients with peri-trochanteric fractures. The study will include 64 patients meeting specific inclusion criteria and will assess inflammatory markers and wound healing at different time points. Patients will be divided into two groups, one receiving trehalose and the other receiving a placebo for 12 weeks. Various measurements and assessments will be conducted, including biochemical assays, wound assessments, anthropometric measurements and dietary intake evaluations. Data analysis will be performed using SPSS software, and statistical tests will be used to compare outcomes between the intervention and control groups.Ethics and dissemination The Ethics Committee of Shahid Beheshti University of Medical Sciences (IR.SBMU.RETECH.REC.1403.191).Trial registration number Iranian Registry of Clinical Trials. IRCT20180404039188N5. URL of trial registry record: https://irct.behdasht.gov.ir/trial/77572. Registration date: 7 July 2024. |
| format | Article |
| id | doaj-art-876a46fc4f1941d494cd4b4946fcec52 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-876a46fc4f1941d494cd4b4946fcec522024-12-16T11:55:09ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-092092Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trialAmirhossein Sahebkar0Hoda Zahedi1Mohammad-Reza Jowshan2Reza Zandi3Alireza Tavallaei Zavareh4Amir Mehrvar5Bahareh Nikooyeh6Shahin Talebi75 Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran8 Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran4 Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran1 Musculoskeletal Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran3 Student Research Committee, Department of Orthopedics, Shahid Beheshti University of Medical Sciences, Tehran, Iran2 Department of Orthopedics, Taleghani Hospital Research Development Committee, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran7 Department of Nutrition Research, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran2 Department of Orthopedics, Taleghani Hospital Research Development Committee, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, IranIntroduction Peri-trochanteric fractures, common among the elderly with osteoporosis, pose significant morbidity and mortality risks. These fractures are increasing due to the ageing population, with Nordic countries seeing a high incidence. They present challenges for orthopaedic surgeons and can lead to functional decline and high medical costs. Hip fractures have severe consequences, including pain, immobility and increased mortality. Managing wound care is complex, involving various healing phases. Trehalose, a disaccharide with antioxidant and anti-inflammatory properties, has shown promise in wound healing and other health conditions. Studies suggest its potential benefits in reducing inflammation and aiding wound healing in peri-trochanteric fracture patients, but more research is needed to confirm its clinical effectiveness in humans.Methods and analysis The study is a double-blind, placebo-controlled randomised clinical trial aiming to evaluate the effect of trehalose consumption on patients with peri-trochanteric fractures. The study will include 64 patients meeting specific inclusion criteria and will assess inflammatory markers and wound healing at different time points. Patients will be divided into two groups, one receiving trehalose and the other receiving a placebo for 12 weeks. Various measurements and assessments will be conducted, including biochemical assays, wound assessments, anthropometric measurements and dietary intake evaluations. Data analysis will be performed using SPSS software, and statistical tests will be used to compare outcomes between the intervention and control groups.Ethics and dissemination The Ethics Committee of Shahid Beheshti University of Medical Sciences (IR.SBMU.RETECH.REC.1403.191).Trial registration number Iranian Registry of Clinical Trials. IRCT20180404039188N5. URL of trial registry record: https://irct.behdasht.gov.ir/trial/77572. Registration date: 7 July 2024.https://bmjopen.bmj.com/content/14/12/e092092.full |
| spellingShingle | Amirhossein Sahebkar Hoda Zahedi Mohammad-Reza Jowshan Reza Zandi Alireza Tavallaei Zavareh Amir Mehrvar Bahareh Nikooyeh Shahin Talebi Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trial BMJ Open |
| title | Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trial |
| title_full | Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trial |
| title_fullStr | Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trial |
| title_full_unstemmed | Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trial |
| title_short | Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trial |
| title_sort | effect of oral trehalose supplementation on inflammation and wound healing in patients with peri trochanteric fractures study protocol for a randomised clinical trial |
| url | https://bmjopen.bmj.com/content/14/12/e092092.full |
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