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Effect of Irvingia gabonensis on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion.
Méndez-Del Villar, M, González-Ortiz, M, Martínez-Abundis, E, Pérez-Rubio, KG, Cortez-Navarrete, M
Journal of medicinal food. 2018;(6):568-574
Abstract
The aim of this study was to evaluate the effect of Irvingia gabonensis on metabolic syndrome (MetS), insulin sensitivity, and insulin secretion. A randomized, double-blind, placebo-controlled clinical trial was performed in 24 patients with MetS in accordance with the International Diabetes Federation criteria. Twelve patients received I. gabonensis (150 mg) twice a day during 90 days, and 12 patients received placebo. Glucose and insulin concentrations were measured during a 2-h oral glucose tolerance test. Also, lipid profile, creatinine, uric acid, and hepatic enzymes were determined. The area under the curve (AUC) of glucose and insulin, total insulin secretion, first phase of insulin secretion, and insulin sensitivity were calculated. Data were tested using non-parametric tests. The Ethics Committee approved the protocol. After I. gabonensis administration, significant decreases in waist circumference (WC) (94.0 ± 8.0 vs. 91.0 ± 8.2 cm, P < .01), glucose 90' (10.0 ± 2.5 vs. 8.6 ± 2.7 mmol/L, P < .05), glucose 120' (8.8 ± 2.4 vs. 7.6 ± 2.7 mmol/L, P < .05), triglycerides (2.5 ± 1.2 vs. 2.0 ± 1.1 mmol/L, P < .05), very low-density lipoproteins (VLDL) (0.5 ± 0.2 vs. 0.4 ± 0.2 mmol/L, P < .05), and AUC of glucose (694 ± 142 vs. 629 ± 172 mmol/L/min, P < .05) were found. Seven patients (58.3%) of the I. gabonensis group showed remission of MetS and two patients (16.7%) of the placebo group (P = .045). I. gabonensis lead to remission of MetS in 58.3% of the patients and significantly decreased WC, glucose 90', glucose 120', triglycerides, VLDL, and AUC of glucose.
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Sugarcane bagasse dietary fiber as an adjuvant therapy for stable chronic obstructive pulmonary disease: a four-center, randomized, double-blind, placebo-controlled study.
Liu, M, Zheng, F, Ni, L, Sun, Y, Wu, R, Zhang, T, Zhang, J, Zhong, X, Li, Y
Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan. 2016;(4):418-26
Abstract
OBJECTIVE To evaluate the efficacy and safety of sugarcane bagasse dietary fiber as an adjuvant therapy for improving quality of life in patients with stable chronic obstructive pulmonary disease (COPD). METHODS This was a multicenter, randomized, double-blind, placebo-controlled trial. A total of 196 participants were randomized into a trial group (treated with 6 g/day sugarcane bagasse plus conventional treatment, n = 98) and a control group (treated with placebo plus conventional treatment, n = 98). All efficacy analyses were performed according to the intention-to-treat (ITT) principle. A per-protocol analysis set (PPS) was used to analyze the cases that completed the clinical trial with good compliance. The trial period was 30 days, with a 6-month follow-up. Pre- and post-treatment pulmonary symptom scores (cough, sputum, wheezing, and dyspnea) were recorded for both groups. The St. George's Respiratory Questionnaire (SGRQ) and the modified Medical Research Council (mMRC) dyspnea scale were assessed before treatment and at the end of the 6-month follow- up. RESULTS The ITT population was 178 and the PPS population was 166. Post-treatment pulmonary clinical symptoms and severity of dyspnea (mMRC and SGRQ evaluation) were significantly improved in both the trial group and the control group (ITT and PPS: P < 0.05). However, there was no statistical difference between the two groups in post-treatment pulmonary symptoms and mMRC. There was a greater reduction in the SGRQ subscales of activity, effect and total score in the trial group compared with the control group (ITT and PPS: P < 0.01). There was no statistical difference in pre- and post-treatment safety variables in either group. CONCLUSION Sugarcane bagasse combined with conventional treatment improved quality of life in patients with stable COPD. Sugarcane bagasse appears to be a safe herbal medicine with potential for treating patients with stable COPD when taken orally as an adjuvant therapy.
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Association of speculum lubrication with pain and Papanicolaou test accuracy.
Uygur, D, Guler, T, Yayci, E, Atacag, T, Comunoglu, C, Kuzey, GM
Journal of the American Board of Family Medicine : JABFM. 2012;(6):798-804
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Abstract
PURPOSE To determine the effects of lubrication of the vaginal speculum before insertion during a Papanicolaou test on perceived pain and quality of the cytology specimen. METHODS Four hundred eligible women participating in cervical cancer screening and an early detection program were randomized with respect to lubricant gel use before speculum insertion. Perceived pain during speculum insertion and cytology results were assessed in study groups. RESULTS The mean age of the patients was 45.7 years (range, 23-77 years). Pain score of the NO GEL group was significantly higher than that of the GEL group (2.3 and 1.6, respectively; P < .05). For premenopausal women, lubricant gel use significantly reduced the pain scores of the participants (P < .05). Cytological interpretations of the Papanicolaou test specimens were comparable among all groups. CONCLUSIONS During the collection of Papanicolaou test specimens, lubrication of the vaginal speculum with a small amount of K-Y Jelly (a water-soluble lubricant gel) decreases the pain associated with insertion of the vaginal speculum among postmenopausal women without obscuring the cytological interpretation of conventional or liquid-based cytology. In women of reproductive age, lubrication of the speculum with K-Y Jelly does not cause a meaningful effect with respect to perceived pain.
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Silver-loaded seaweed-based cellulosic fiber improves epidermal skin physiology in atopic dermatitis: safety assessment, mode of action and controlled, randomized single-blinded exploratory in vivo study.
Fluhr, JW, Breternitz, M, Kowatzki, D, Bauer, A, Bossert, J, Elsner, P, Hipler, UC
Experimental dermatology. 2010;(8):e9-15
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Abstract
BACKGROUND The epidermal part of the skin is the major interface between the internal body and the external environment. The skin has a specific physiology and is to different degrees adapted for protection against multiple exogenous stress factors. Clothing is the material with the longest and most intensive contact to human skin. It plays a critical role especially in inflammatory dermatoses or skin conditions with an increased susceptibility of bacterial and fungal infections like atopic dermatitis. Previously, we have shown a dose-dependent antibacterial and antifungal activity of silver-loaded seaweed-based cellulosic fibres. AIM OF THE STUDY We studied the mode of action of silver-loaded seaweed-based cellulosic fiber and performed a broad safety assessment. The principal aim was to analyse the effects of wearing the textile on epidermal skin physiology in 37 patients with atopic dermatitis in a controlled, randomized single-blinded in vivo study. Furthermore, the sensitization potential was tested in a patch test in 111 panellists. RESULTS We could demonstrate in vitro a dose-dependent scavenging of induced reactive oxygen species by silver-loaded seaweed-based cellulosic fibers. Safety assessment of these fibres showed no detectable release of silver ions. Furthermore, ex vivo assessment after 24 h application both in healthy volunteers and patients with atopic dermatitis by sequential tape stripping and subsequently raster electron microscopy and energy dispersive microanalysis analysis revealed no detectable amounts of silver in any of stratum corneum layers. Serum analysis of silver showed no detectable levels. The in vivo patch testing of 111 volunteers revealed no sensitization against different SeaCell Active (SeaCell GmbH, Rudolstadt, Germany) containing fabrics. The in vivo study on 37 patients with known atopic dermatitis and mild-to-moderate eczema on their arms were randomly assigned to either silver-loaded seaweed fibre T-shirts or to cotton T-shirts for 8 weeks. A significant reduction in Staphylococcus aureus colonization was detectable for the silver T-shirts compared with cotton T-shirts without any changes in non-pathogenic surface bacteria colonization. Furthermore, a more pronounced improvement in barrier function (transepidermal water loss) was observed in mildly involved eczema areas during the first 4 weeks of the study. Stratum corneum hydration and surface pH improved in both treatment groups over time. CONCLUSION The tested silver-loaded seaweed fibre can be regarded as safe and seams to be suited for application in bio-active textiles in atopic dermatitis based on its positive in vivo activity.
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IGOB131, a novel seed extract of the West African plant Irvingia gabonensis, significantly reduces body weight and improves metabolic parameters in overweight humans in a randomized double-blind placebo controlled investigation.
Ngondi, JL, Etoundi, BC, Nyangono, CB, Mbofung, CM, Oben, JE
Lipids in health and disease. 2009;:7
Abstract
BACKGROUND A recent in vitro study indicates that IGOB131, a novel seed extract of the traditional West African food plant Irvingia gabonensis, favorably impacts adipogenesis through a variety of critical metabolic pathways including PPAR gamma, leptin, adiponectin, and glycerol-3 phosphate dehydrogenase. This study was therefore aimed at evaluating the effects of IGOB131, an extract of Irvingia gabonensis, on body weight and associated metabolic parameters in overweight human volunteers. METHODS The study participants comprised of 102 healthy, overweight and/or obese volunteers (defined as BMI > 25 kg/m2) randomly divided into two groups. The groups received on a daily basis, either 150 mg of IGOB131 or matching placebo in a double blinded fashion, 30-60 minutes before lunch and dinner. At baseline, 4, 8 and 10 weeks of the study, subjects were evaluated for changes in anthropometrics and metabolic parameters to include fasting lipids, blood glucose, C-reactive protein, adiponectin, and leptin. RESULTS Significant improvements in body weight, body fat, and waist circumference as well as plasma total cholesterol, LDL cholesterol, blood glucose, C-reactive protein, adiponectin and leptin levels were observed in the IGOB131 group compared with the placebo group. CONCLUSION Irvingia gabonensis administered 150 mg twice daily before meals to overweight and/or obese human volunteers favorably impacts body weight and a variety of parameters characteristic of the metabolic syndrome. This is the first double blind randomized placebo controlled clinical trial regarding the anti-obesity and lipid profile modulating effects of an Irvingia gabonensis extract. The positive clinical results, together with our previously published mechanisms of gene expression modulation related to key metabolic pathways in lipid metabolism, provide impetus for much larger clinical studies. Irvingia gabonensis extract may prove to be a useful tool in dealing with the emerging global epidemics of obesity, hyperlipidemia, insulin resistance, and their co-morbid conditions.
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Influences of a dietary supplement in combination with an exercise and diet regimen on adipocytokines and adiposity in women who are overweight.
Fragala, MS, Kraemer, WJ, Volek, JS, Maresh, CM, Puglisi, MJ, Vingren, JL, Ho, JY, Hatfield, DL, Spiering, BA, Forsythe, CE, et al
European journal of applied physiology. 2009;(5):665-72
Abstract
The influence of a proprietary blend of modified cellulose and cetylated fatty acids (Trisynextrade mark, Imagenetix, Inc., San Diego, CA 92127, USA) on adipocytokine and regional body composition responses to a weight loss program was examined. Twenty-two women (Supplement group (S) (n = 11): age = 36.8 +/- 7.2 years; weight = 87.1 +/- 6.2 kg; % body fat = 43.4 +/- 4.1; Placebo group (P) (n = 11): age = 38.3 +/- 6.8 years; weight = 86.9 +/- 4.7 kg; % body fat = 44.3 +/- 2.0) completed an 8-week placebo-controlled, double-blind study consisting of a caloric restricted diet and cardiovascular exercise. Body composition and serum insulin, leptin, and adiponectin were assessed at pre-, mid-, and post-intervention. From pre- to post-intervention, significant decreases (P < 0.05) were observed for body weight (S: 87.1 +/- 6.2-77.9 +/- 5.1 kg; P: 86.9 +/- 4.7-82.7 +/- 3.8 kg) (P < 0.05 S vs. P), % body fat (S: 43.4 +/- 4.1-36.1 +/- 3.6; P: 44.3 +/- 2.0-40.6 +/- 1.2) (P < 0.05 S vs. P), leptin (S: 28.3 +/- 3.5-16.2 +/- 2.6 ng ml(-1); P: 29.4 +/- 3.2-19.9 +/- 1.1 ng ml(-1)) (P < 0.05 S vs. P), and insulin (S: 7.3 +/- 0.8-5.1 +/- 0.2 mU l(-1); P: 7.7 +/- 0.9-5.1 +/- 0.3 mU l(-1)). Serum adiponectin increased (P < 0.05) (S: 12.2 +/- 2.4-26.3 +/- 3.0 microg ml(-1): 12.6 +/- 2.0-21.8 +/- 3.1 microg ml(-1)) (P < 0.05 for S vs. P). Supplementation with a proprietary blend of modified cellulose and cetylated fatty acids during an 8-week weight loss program exhibited favorable effects on adipocytokines and regional body composition.
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The use of a Cissus quadrangularis/Irvingia gabonensis combination in the management of weight loss: a double-blind placebo-controlled study.
Oben, JE, Ngondi, JL, Momo, CN, Agbor, GA, Sobgui, CS
Lipids in health and disease. 2008;:12
Abstract
AIM: To evaluate the effects of two formulations, Cissus quadrangularis-only and a Cissus quadrangularis/Irvingia gabonensis combination, on weight loss in overweight and obese human subjects. METHODS The study was a 10 week randomized, double-blind, placebo-controlled design involving 72 obese or overweight participants (45.8% male; 54.2% female; ages 21-44; mean age = 29.3). The participants were randomly divided into three equal (n = 24) groups: placebo, Cissus quadrangularis-only, and Cissus quadrangularis/Irvingia gabonensis combination. Capsules containing the placebo or active formulations were administered twice daily before meals; no major dietary changes nor exercises were suggested during the study. A total of six anthropomorphic and serological measurements (body weight, body fat, waist size; total plasma cholesterol, LDL cholesterol, fasting blood glucose level) were taken at baseline and at 4, 8 and 10 weeks. RESULTS Compared to the placebo group, the two active groups showed a statistically significant difference on all six variables by week 10. The magnitude of the differences was noticeable by week 4 and continued to increase over the trial period. CONCLUSION Although the Cissus quadrangularis-only group showed significant reductions on all variables compared to the placebo group, the Cissus quadrangularis/Irvingia gabonensis combination resulted in even larger reductions. This apparently synergistic formulation should prove helpful in the management of obesity and its related complications.
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Angiogenin: a novel inhibitor of neutrophil lactoferrin release during extracorporeal circulation.
Schmaldienst, S, Oberpichler, A, Tschesche, H, Hörl, WH
Kidney & blood pressure research. 2003;(2):107-12
Abstract
Degranulation of polymorphonuclear leukocytes (PMNL) occurs during extracorporeal circulation. A degranulation-inhibiting protein identical to angiogenin was recently isolated from high-flux dialyzer ultrafiltrate. This protein inhibits the release of lactoferrin and metalloproteinases from PMNL in vitro. In the present study, we investigated end-stage renal disease patients undergoing regular hemodialysis treatment with either high-flux dialyzers (n = 51) or low-flux dialyzers (n = 44), and chronically uremic patients undergoing hemodiafiltration (n = 30). Hemodialysis therapy with low-flux polysulfone or cellulose triacetate membranes caused no or only minimal reduction (≤8%) of plasma angiogenin levels within 2 h of dialysis treatment associated with a 1.6-fold lactoferrin release from PMNL. Hemodialysis therapy with high-flux membranes (e.g. cellulose triacetate, polymethylmethacrylate) or hemodiafiltration resulted in a reduction of plasma angiogenin levels by 20-40% after 2 h associated with a nearly 4-fold PMNL lactoferrin release. The release of PMNL elastase was not affected by the different treatment modalities used. We conclude that high angiogenin plasma levels protect against lactoferrin release from PMNL during extracorporeal circulation in chronically uremic patients. A decrease of plasma angiogenin between 20 and 40% during extracorporeal circulation, however, results in marked PMNL lactoferrin release. This novel mechanism may explain, at least in part, PMNL degranulation also in non complement activating high-flux membranes.
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Nasal glucagon delivery using microcrystalline cellulose in healthy volunteers.
Teshima, D, Yamauchi, A, Makino, K, Kataoka, Y, Arita, Y, Nawata, H, Oishi, R
International journal of pharmaceutics. 2002;(1-2):61-6
Abstract
We developed an intranasal powder form of glucagon to improve metabolic status and fatty liver in patients with pancreatectomy. Microcrystalline cellulose, which is commonly used in commercial preparations for allergic rhinitis was used as an absorption enhancer. We compared the intranasal powder form with some spray solutions of glucagon with regard to glucagon absorption, concentration of blood glucose, stability and nasal irritation. The absorption of glucagon from the spray solution including 1.5% sodium glycocholate or 1% sodium caprate was 1.3- and 2.6-fold higher than that from the powder form mixed with microcrystalline cellulose at a ratio of 1:69, respectively. The C(max) values of plasma glucose were 2.18, 3.39 and 1.56 mmol l(-1) in the spray solutions including sodium glycocholate and sodium caprate and in the powder form, respectively. However, glucagon in spray solutions was unstable, but that in the powder form was stable at 5 and 25 degrees C for at least 84 days. The spray solution caused strong irritation, but the powder form did not. These results suggested usefulness of the powder form of glucagon for treatment of pancreatectomized patients.