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Effects of a hydroalcoholic extract of Juglans regia (walnut) leaves on blood glucose and major cardiovascular risk factors in type 2 diabetic patients: a double-blind, placebo-controlled clinical trial

BACKGROUND: We aimed to evaluate the effects of a hydroalcoholic extract of Juglans regia L. leaves on blood glucose level and cardiovascular risk factors in type 2 diabetic patients. METHODS: In this randomized, double-blind, placebo-controlled, parallel-group (2 arms) clinical trial, 50 diabetic p...

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Autores principales: Rabiei, Khadijeh, Ebrahimzadeh, Mohammad Ali, Saeedi, Majid, Bahar, Adele, Akha, Ozra, Kashi, Zahra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6031195/
https://www.ncbi.nlm.nih.gov/pubmed/29973195
http://dx.doi.org/10.1186/s12906-018-2268-8
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author Rabiei, Khadijeh
Ebrahimzadeh, Mohammad Ali
Saeedi, Majid
Bahar, Adele
Akha, Ozra
Kashi, Zahra
author_facet Rabiei, Khadijeh
Ebrahimzadeh, Mohammad Ali
Saeedi, Majid
Bahar, Adele
Akha, Ozra
Kashi, Zahra
author_sort Rabiei, Khadijeh
collection PubMed
description BACKGROUND: We aimed to evaluate the effects of a hydroalcoholic extract of Juglans regia L. leaves on blood glucose level and cardiovascular risk factors in type 2 diabetic patients. METHODS: In this randomized, double-blind, placebo-controlled, parallel-group (2 arms) clinical trial, 50 diabetic patients were divided into two groups: treatment group (receive the capsules containing 100 mg J. regia leaf extract) and control group (receive the capsules containing placebo, microcrystallin cellulose). Baseline participant data were matched between the two arms of the study. We administered the prepared capsules to the patients twice daily for 8 weeks. Blood glucose level, glycosylated hemoglobin (HbA1c) level, body weight, body mass index, blood pressure, lipid profile, serum insulin, and insulin resistance were compared between the two groups before and after the intervention. P < 0.05 was considered significant. RESULTS: After excluding eleven patients, 20 received J. regia leaf extract and 20 patients received placebo. The J. regia leaf extract did not significantly change the blood glucose and insulin resistance condition. However, in this group, body weight, body mass index, and systolic blood pressure significantly decreased compared with the baseline measurements (P = 0.028, P = 0.030, and P = 0.005, respectively). The lipid profile did not change significantly compared with the baseline measurements. In the control group, postprandial glucose and HbA1c levels significantly decreased after the intervention (P = 0.030 and P = 0.028, respectively). The other variables were not significantly different in this group. At the end of the study, the variables were not significantly different between the two groups. CONCLUSION: In this double-blind study, 200 mg/d of J. regia leaf extract had no significant effect on blood glucose level and HOMA-IR score in patients with type 2 diabetes. However, the J. regia leaf extract was effective in reducing body weight and blood pressure. An accidental finding of our study was that microcrystalline cellulose, a widely used placebo in clinical trials, led to a reduction in blood glucose level. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT: 138901203180 N2, 2010/6/6); retrospectively registered.
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spelling pubmed-60311952018-07-11 Effects of a hydroalcoholic extract of Juglans regia (walnut) leaves on blood glucose and major cardiovascular risk factors in type 2 diabetic patients: a double-blind, placebo-controlled clinical trial Rabiei, Khadijeh Ebrahimzadeh, Mohammad Ali Saeedi, Majid Bahar, Adele Akha, Ozra Kashi, Zahra BMC Complement Altern Med Research Article BACKGROUND: We aimed to evaluate the effects of a hydroalcoholic extract of Juglans regia L. leaves on blood glucose level and cardiovascular risk factors in type 2 diabetic patients. METHODS: In this randomized, double-blind, placebo-controlled, parallel-group (2 arms) clinical trial, 50 diabetic patients were divided into two groups: treatment group (receive the capsules containing 100 mg J. regia leaf extract) and control group (receive the capsules containing placebo, microcrystallin cellulose). Baseline participant data were matched between the two arms of the study. We administered the prepared capsules to the patients twice daily for 8 weeks. Blood glucose level, glycosylated hemoglobin (HbA1c) level, body weight, body mass index, blood pressure, lipid profile, serum insulin, and insulin resistance were compared between the two groups before and after the intervention. P < 0.05 was considered significant. RESULTS: After excluding eleven patients, 20 received J. regia leaf extract and 20 patients received placebo. The J. regia leaf extract did not significantly change the blood glucose and insulin resistance condition. However, in this group, body weight, body mass index, and systolic blood pressure significantly decreased compared with the baseline measurements (P = 0.028, P = 0.030, and P = 0.005, respectively). The lipid profile did not change significantly compared with the baseline measurements. In the control group, postprandial glucose and HbA1c levels significantly decreased after the intervention (P = 0.030 and P = 0.028, respectively). The other variables were not significantly different in this group. At the end of the study, the variables were not significantly different between the two groups. CONCLUSION: In this double-blind study, 200 mg/d of J. regia leaf extract had no significant effect on blood glucose level and HOMA-IR score in patients with type 2 diabetes. However, the J. regia leaf extract was effective in reducing body weight and blood pressure. An accidental finding of our study was that microcrystalline cellulose, a widely used placebo in clinical trials, led to a reduction in blood glucose level. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT: 138901203180 N2, 2010/6/6); retrospectively registered. BioMed Central 2018-07-04 /pmc/articles/PMC6031195/ /pubmed/29973195 http://dx.doi.org/10.1186/s12906-018-2268-8 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Rabiei, Khadijeh
Ebrahimzadeh, Mohammad Ali
Saeedi, Majid
Bahar, Adele
Akha, Ozra
Kashi, Zahra
Effects of a hydroalcoholic extract of Juglans regia (walnut) leaves on blood glucose and major cardiovascular risk factors in type 2 diabetic patients: a double-blind, placebo-controlled clinical trial
title Effects of a hydroalcoholic extract of Juglans regia (walnut) leaves on blood glucose and major cardiovascular risk factors in type 2 diabetic patients: a double-blind, placebo-controlled clinical trial
title_full Effects of a hydroalcoholic extract of Juglans regia (walnut) leaves on blood glucose and major cardiovascular risk factors in type 2 diabetic patients: a double-blind, placebo-controlled clinical trial
title_fullStr Effects of a hydroalcoholic extract of Juglans regia (walnut) leaves on blood glucose and major cardiovascular risk factors in type 2 diabetic patients: a double-blind, placebo-controlled clinical trial
title_full_unstemmed Effects of a hydroalcoholic extract of Juglans regia (walnut) leaves on blood glucose and major cardiovascular risk factors in type 2 diabetic patients: a double-blind, placebo-controlled clinical trial
title_short Effects of a hydroalcoholic extract of Juglans regia (walnut) leaves on blood glucose and major cardiovascular risk factors in type 2 diabetic patients: a double-blind, placebo-controlled clinical trial
title_sort effects of a hydroalcoholic extract of juglans regia (walnut) leaves on blood glucose and major cardiovascular risk factors in type 2 diabetic patients: a double-blind, placebo-controlled clinical trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6031195/
https://www.ncbi.nlm.nih.gov/pubmed/29973195
http://dx.doi.org/10.1186/s12906-018-2268-8
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