Metabolic Management in Overweight Subjects with Naive Impaired Fasting Glycaemia by Means of a Highly Standardized Extract From Cynara scolymus: A Double-blind, Placebo-controlled, Randomized Clinical Trial
The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double‐blind, placebo‐controlled trial has been performed in 55 overweight...
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| Published in | Phytotherapy research Vol. 28; no. 1; pp. 33 - 41 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Blackwell Publishing Ltd
01.01.2014
Wiley Subscription Services, Inc |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0951-418X 1099-1573 1099-1573 |
| DOI | 10.1002/ptr.4950 |
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| Abstract | The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double‐blind, placebo‐controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 ± 0.56 mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600 mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c‐Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (−9.6%), HOMA (−11.7%), glycosylated haemoglobin (−2.3%), ADAG (−3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG. Copyright © 2013 John Wiley & Sons, Ltd. |
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| AbstractList | The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naive impaired fasting glycaemia (IFG). A randomized, double-blind, placebo-controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 plus or minus 0.56mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c-Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (-9.6%), HOMA (-11.7%), glycosylated haemoglobin (-2.3%), ADAG (-3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG. Copyright [copy 2013 John Wiley & Sons, Ltd. The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double-blind, placebo-controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 ± 0.56 mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600 mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c-Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (-9.6%), HOMA (-11.7%), glycosylated haemoglobin (-2.3%), ADAG (-3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG. The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus ( Cs ) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double‐blind, placebo‐controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 ± 0.56 mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600 mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c‐Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (−9.6%), HOMA (−11.7%), glycosylated haemoglobin (−2.3%), ADAG (−3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG. Copyright © 2013 John Wiley & Sons, Ltd. The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double-blind, placebo-controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11±0.56mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c-Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (-9.6%), HOMA (-11.7%), glycosylated haemoglobin (-2.3%), ADAG (-3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG. Copyright © 2013 John Wiley & Sons, Ltd. [PUBLICATION ABSTRACT] The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double-blind, placebo-controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 ± 0.56 mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600 mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c-Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (-9.6%), HOMA (-11.7%), glycosylated haemoglobin (-2.3%), ADAG (-3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG.The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double-blind, placebo-controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 ± 0.56 mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600 mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c-Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (-9.6%), HOMA (-11.7%), glycosylated haemoglobin (-2.3%), ADAG (-3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG. The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double‐blind, placebo‐controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 ± 0.56 mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600 mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c‐Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (−9.6%), HOMA (−11.7%), glycosylated haemoglobin (−2.3%), ADAG (−3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG. Copyright © 2013 John Wiley & Sons, Ltd. |
| Author | Riva, Antonella Faliva, Milena Sala, Patrizio Opizzi, Annalisa Perna, Simone Bombardelli, Ezio Morazzoni, Paolo Rondanelli, Mariangela Giacosa, Attilio |
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Proc. West. Pharmacol. Soc. 45: 118-124. Hui H, Zhao X, Perfetti R. 2005. Structure and function studies of glucagon-like peptide-1 (GLP-1): the designing of a novel pharmacological agent for the treatment of diabetes. Diabetes Metab. Res. Rev. 21: 313-331. American Diabetes Association and National Institute of Diabetes, Digestive and Kidney Diseases. 2002. The prevention or delay of type 2 diabetes. Diabetes Care 25: 742-749. Hui H, Tang G, Go VL. 2009. Hypoglycemic herbs and their action mechanisms. Chin Med 4: 11. Karthikesan K, Pari L, Menon VP. 2010. Combined treatment of tetrahydrocurcumin and chlorogenic acid exerts potential antihyperglycemic effect on streptozotocin-nicotinamide-induced diabetic rats. Gen. Physiol. Biophys. 29: 23-30. Garber AJ, Spann SJ. 2008. An overview of incretin clinical trials. J. Fam. Pract. 57: S10-S18. Herling AW, Burger HJ, Schwab D, . 1998. Pharmacodynamic profile of a novel inhibitor of the hepatic glucose-6-phosphatase system. Am. J. Physiol. 274: G1087-G1093. Rondanelli M, Giacosa A, Orsini F, Opizzi A, Villani S. 2011. Appetite Control and Glycaemia Reduction in Overweight Subjects treated with a Combination of Two Highly Standardized Extracts from Phaseolus vulgaris and Cynara scolymus. Phytother. Res. doi: 10.1002/ptr.3425. Shan JJ, Rodgers K, Lai CT, Sutherland SK. 2007. Challenges in natural health product research: The importance of standardization. Proc. West. Pharmacol. Soc. 50: 24-30. Haber GB, Heaton KW, Murphy D, Burroughs LF. 1977. Depletion and disruption of dietary fibre. Effects on satiety, plasma-glucose, and serum-insulin. Lancet 2: 679-682. Schütz K, Muks E, Carle R, Schieber A. 2006. Quantitative determination of phenolic compounds in artichoke-based dietary supplements and pharmaceuticals by high-performance liquid chromatography. J. Agric. Food Chem. 54: 8812-8817. Steer RA, Cavalieri TA, Leonard DM, Beck AT. 1999. Use of the Beck Depression Inventory for Primary Care to screen for major depression disorders. Gen. Hosp. Psychiatry 21: 106-111. Saénz Rodriguez T, Garcìa Giménez D, de la Puerta Vàzguez R. 2002. Choleretic activity and biliary elimination of lipids and bile acids induced by an artichoke leaf extract in rats. Phytomedicine 9: 687-693. DECODE Study Group, the European Diabetes Epidemiology Group. 2001. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch. Intern. Med. 161: 397-405. Nathan DM, Kuenen J, Borg R, Zheng H, Schoenfeld D, Heine RJ; A1c-Derived Average Glucose Study Group. 2008Translating the A1C assay into estimated average glucose values. Translating the A1C assay into estimated average glucose values. Diabetes Care 31: 1473-1478. 1984; 40 1997; 40 2001; 161 1997; 339 1996; 19 2002; 19 1989; 119 2002; 9 2011 1997; 20 2006; 54 2008; 57 2005; 21 2006; 6 1999; 21 2000; 373 2007; 50 2008; 52 2008; 31 2007; 97 2001; 24 1959; 234 2003; 52 1998; 351 1998; 274 2004; 76 2002; 25 1965; 20 2010; 87 2010; 25 2010; 29 2002; 45 2007; 9 2003; 26 1985 1977; 2 2007; 4 2009; 4 Hernandez‐Galicia E (e_1_2_6_18_1) 2002; 45 e_1_2_6_30_1 e_1_2_6_19_1 Fantini N (e_1_2_6_10_1) 2010; 25 e_1_2_6_13_1 e_1_2_6_14_1 e_1_2_6_35_1 e_1_2_6_11_1 e_1_2_6_34_1 e_1_2_6_33_1 Garber AJ (e_1_2_6_12_1) 2008; 57 e_1_2_6_39_1 e_1_2_6_15_1 e_1_2_6_38_1 e_1_2_6_16_1 e_1_2_6_37_1 e_1_2_6_21_1 e_1_2_6_20_1 Segal HL (e_1_2_6_31_1) 1959; 234 Herling AW (e_1_2_6_17_1) 1998; 274 Shan JJ (e_1_2_6_32_1) 2007; 50 e_1_2_6_9_1 e_1_2_6_8_1 Thompson Coon JS (e_1_2_6_36_1) 2003; 52 e_1_2_6_5_1 e_1_2_6_4_1 e_1_2_6_7_1 e_1_2_6_6_1 e_1_2_6_25_1 e_1_2_6_24_1 e_1_2_6_3_1 e_1_2_6_23_1 e_1_2_6_2_1 e_1_2_6_22_1 e_1_2_6_29_1 e_1_2_6_28_1 e_1_2_6_27_1 e_1_2_6_26_1 |
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| SubjectTerms | Adult Anthropometry Blood Glucose - analysis Cholesterol - blood Cynara scolymus Cynara scolymus - chemistry dietary supplement Dietary Supplements Double-Blind Method Female Glycated Hemoglobin A - metabolism Humans Hyperglycemia - drug therapy Hyperglycemia - physiopathology impaired fasting glycaemia Male Middle Aged overweight Overweight - drug therapy Plant Extracts - therapeutic use Triglycerides - blood Young Adult |
| Title | Metabolic Management in Overweight Subjects with Naive Impaired Fasting Glycaemia by Means of a Highly Standardized Extract From Cynara scolymus: A Double-blind, Placebo-controlled, Randomized Clinical Trial |
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