scholarly journals Efficacy and safety of Citrus sudachi peel in obese adults: A randomized, double-blind, pilot study

2014 ◽  
Vol 4 (7) ◽  
pp. 276 ◽  
Author(s):  
Masashi Akaike ◽  
Ken-ichi Aihara ◽  
Hiroaki Yanagawa ◽  
Takashi Iwase ◽  
Sumiko Yoshida ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Trials ◽  
Body Weight ◽  
Placebo Group ◽  
Waist Circumference ◽  
Abdominal Obesity ◽  
Serum Triglyceride ◽  
Metabolic Risk ◽  
Efficacy And Safety ◽  
Double Blind

Objective: This study was undertaken to explore the efficacy and safety of Citrus sudachi peel for metabolic risk factors in obese male and female adults.Background: Citrus sudachi Hort. ex Shirai (Rutaceae), called “sudachi”, is a small, round, green citrus fruit that is mainly cultivated in Tokushima Prefecture in Japan. Our group reported that Citrus sudachi peel powder improved glucose tolerance and dyslipidemia in Zucher-fatty rats and reduced hyperglycemia and hypertriglyceridemia in GK diabetic rats.Materials and Methods: We conducted a randomized, double-blind, placebo-controlled trial in 40 participants with abdominal obesity and metabolic risk factors including hypertension, impaired glucose tolerance and elevated triglyceride levels. Participants were randomized to receive either tablets that contained 1.3 g dried Citrus sudachi peel powder or placebo tablets for 12 weeks. The sudachi peel group included 14 males and 5 females with a mean age of 54.5 years, and the placebo group included 18 males and 2 females with a mean age of 51.9 years. Results: Physical status including body weight, waist circumference and blood pressure and laboratory markers including metabolic parameters were not different at any observation point between the two groups. However, among participants with serum triglyceride levels of more than 120 mg/dl, body weight, waist circumference and serum triglyceride levels were significantly decreased at several observation points after the start of treatment in the sudachi peel group but not in the placebo group. No serious adverse events were observed in the sudachi peel group. Conclusions: Citrus sudachi peel has the potential effect to safely improve abdominal obesity and lower serum levels of TG in obese individuals with hypertriglyceridemia. A large-scale randomized, double-blind clinical study targeting subjects with both abdominal obesity and high TG levels is needed to confirm the metabolic effects of Citrus sudachi peel.Trial registration: UMIN Clinical Trials Registry (UMIN-CTR) UMIN000002682.  Accession number of the Ethics Committee for Clinical Trials of Food in Tokushima University Hospital is F5.Key words: health functional food, anti-obesity, triglyceride

scholarly journals Postprandial Glucose Levels Are Better Associated with the Risk Factors for Diabetes Compared to Fasting Glucose and Glycosylated Hemoglobin (HbA1c) Levels in Elderly Prediabetics: Beneficial Effects of Polyherbal Supplements—A Randomized, Double-Blind, Placebo Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-13
Author(s):  
Jingfen Zhu ◽  
Guoqiang Xing ◽  
Tian Shen ◽  
Gang Xu ◽  
Yun Peng ◽  
...  
Keyword(s):  
Risk Factors ◽  
Body Weight ◽  
Placebo Group ◽  
Waist Circumference ◽  
Fasting Glucose ◽  
Postprandial Glucose ◽  
Elderly Individuals ◽  
Glucose Levels ◽  
Polyherbal Formulation ◽  
Hba1c Levels

Backgrounds. Prediabetes is a condition in which a person’s blood glucose levels are higher than normal physiological levels but lower compared to patients with diabetes. Up to 70% of individuals with prediabetes will eventually develop diabetes. To date, there have been no pharmaceutical drugs to treat diabetes. It is believed that early diagnosis and nonpharmacological intervention for prediabetes are critical for effective prevention of diabetes. Most individuals with prediabetes remain undiagnosed even after being evaluated using the standard tests for fasting glucose (FG) and HbA1c. We investigated if postprandial glucose levels (2h-PG) were associated with pre/diabetes and if polyherbal supplements could be beneficial for individuals with prediabetes. Materials and Methods. 100 elderly individuals with impaired 2h-PG or fasting glucose levels were recruited to receive either a 12-week supplement of GlucoVita (an antioxidative polyherbal formulation) (n=50) or placebo (n=50). Results. No baseline differences were observed for FG, HbA1c, or 2h-PG. Individuals who received a twelve-week administration of GlucoVita supplements had significantly reduced 2h-PG (8.15±1.67 versus 7.35±2.06 mmol/l, P<0.05) levels compared to individuals in the placebo group. In addition, HbA1c levels were lower in individuals who received GlucoVita (5.81±0.49 %) compared to the individuals in the placebo group (6.00±0.51%) (P=0.08) after 12-weeks. Stratified analysis, based on impaired fasting glucose (IFG), 2h-PG, metabolic symptom, and age, demonstrated that, after the 12-week intervention, HbA1c levels were significantly lower in the GlucoVita administered group compared to the placebo group (IFG subgroup; 5.85±0.46%, n= 27 versus 6.14±0.50, n=33, P<0.05) and the metabolic symptom-free subgroup (5.73±0.45%, n=23 versus 6.04±0.52%, n=24, P<0.05). GlucoVita also reduced FG in individuals with normal 2h-PG (6.37±0.27 versus 6.08±0.38 mmol/l, P<0.05). Baseline 2h-PG levels, but not HbA1c or FG levels, were significantly correlated with body weight, waist circumference, and BMI (r=0.25, P<0.05; r=0.31, P<0.01; r=0.22, P<0.05, respectively). Conclusion. 2h-PG levels were better associated with body weight, waist circumference, and BMI risk factors compared to FG and HbA1c levels in elderly individuals with prediabetes. Polyherbal formulation GlucoVita supplements improved 2h-PG and HbA1c levels only in elderly individuals who were overweight but were symptom-free and under 65 years of age. Due to the small cohort size of this pilot study, future studies are required to validate our findings.

scholarly journals Efficacy of a novel herbal composition licorice flavonoid oil in subject with metabolic syndrome: a randomized double-blind placebo-controlled clinical study

2017 ◽  
Vol 7 (3) ◽  
pp. 210 ◽  
Author(s):  
Kazunori Hosoe ◽  
Kaku Nakagawa ◽  
Takahiro Ueda ◽  
Masato Hosoda ◽  
Sanjib Kumar Panda ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Metabolic Syndrome ◽  
Body Mass Index ◽  
Body Weight ◽  
Placebo Group ◽  
Waist Circumference ◽  
Fasting Blood Glucose ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Fat Composition

Background: In order to evaluate the effects of licorice flavonoid oil (LFO) on waist circumference, blood pressure, lipid profile, body fat composition, body weight, body mass index (BMI), and fasting blood glucose in patients with metabolic syndrome, a 12 week randomized double-blind placebo-controlled study was conducted. Methods: Fifty patients with metabolic syndrome aged between 18-75 years were assigned to either the LFO or placebo group. Abdominal waist circumference, blood pressure, body weight, and BMI were assessed at baseline, week 4, week 8, and week 12. Clinical laboratory examinations, fat composition, and fasting blood glucose level were assessed at baseline (week 0) and final visit (week 12).Results: A total of 50 subjects (25 subjects in each group) completed the 12 week study. Significant changes from baseline were observed in body weight, waist circumference, and BMI in the LFO group compared to the placebo group from week 4 or week 8 onwards. No adverse events were noted throughout the study. Conclusion: The present study suggests that LFO is a promising dietary nutrient for improving metabolic syndrome, particularly through its beneficial effect of reducing body weight, BMI, and possibly the amount of visceral fat. Keywords: licorice flavonoid oil; Glycyrrhiza glabra L.; metabolic syndrome; body mass index

Abstract P364: Preliminary Study of the Effects of Coffee Mannooligosaccharides Supplementation on Lipid Profile.

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Stacy Tsai ◽  
Arindam RoyChoudhury ◽  
Majella O'Keeffe ◽  
Marie-Pierre St-Onge
Keyword(s):  
Risk Factors ◽  
Weight Loss ◽  
Body Composition ◽  
Body Weight ◽  
Regression Analysis ◽  
Placebo Group ◽  
Lipid Profile ◽  
Metabolic Risk ◽  
Sample Analysis ◽  
Weight Loss Study

Introduction: Coffee-derived mannooligosaccharides (MOS) have been shown to have prebiotic activity and improve body composition in overweight individuals. However, the effects of MOS consumption on metabolic risk factors have not been studied. The overall goal of this study was to determine the effects of MOS consumption on body composition and metabolic risk factors. Hypothesis: We hypothesized that the intake of MOS would result in improvements in lipid profile after controlling for changes in body weight. Design: Two separate randomized, placebo-controlled studies, weight maintenance or weight loss, were conducted to assess the role of MOS for weight management. For each study, participants consumed MOS (4 g/d) or Placebo coffee beverages for 12 wk. Fasting blood samples were taken at baseline and endpoint of both studies. Complete datasets were available for 31 participants who consumed MOS (13 in weight loss study) and 32 (17 in weight loss study) who consumed the Placebo beverage. Regression analysis wasperformed including body weight, age, sex, time and time x beverage interaction as covariates to determine the effects of MOS supplementation on serum lipid levels. The regression analysis was additionally performed on a sub-sample with mildly elevated low-density lipoprotein cholesterol (LDL-C &#8805; 130 mg/dL). Results: Participants had a mean age (SEM) and body mass index of 45.0 ± 11.3 y and 30.2 ± 2.6 kg/m2. In the whole sample analysis, there was no time x beverage interaction for any of the lipid parameters (all P> 0.05). Total cholesterol (TC) changed by -2.5 ± 15.8% in the MOS group and by -1.0 ± 11.3% in the Placebo group. LDL-C changed by -2.0 ± 30.1% in the MOS group and by -2.2 ± 21.4% in the Placebo group. In the sub-sample analysis (MOS n = 12, Placebo n = 18), there was no time x beverage interaction on TC (MOS-17.1 ± 9.1% vs Placebo -5.6±10.1%, P = 0.197). Similar results were observed for LDL-C (MOS -25.6 ± 14.4% vs Placebo -8.4 ± 17.3%, P = 0.164) and triglycerides (MOS -8.5 ± 100.2% vs Placebo -3.4± 25.9%, P = 0.358). Conclusions: Our data provide preliminary information on the effects of MOS supplementation on cardiovascular risk profile. Although not significant, our results suggest that MOS consumption may be useful to improve lipid profile in individuals with elevated LDL-C but our sample size was inadequate to affirm this with confidence. Future studies should be specifically designed to determine the effects of MOS supplementation on lipid profiles of at risk individuals.

scholarly journals Cardio-Metabolic Risk Factors in Scottish South Asian and Caucasian Youth

2021 ◽  
Vol 18 (9) ◽  
pp. 4667
Author(s):  
Meizi Wang ◽  
Jianhua Ying ◽  
Ukadike Chris Ugbolue ◽  
Duncan S. Buchan ◽  
Yaodong Gu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Body Mass Index ◽  
Waist Circumference ◽  
Body Mass ◽  
South Asian ◽  
Metabolic Risk Factors ◽  
Individual Risk ◽  
Metabolic Risk ◽  
Asian Adolescents ◽  
Individual Risk Factors

(1) Background: Scotland has one of the highest rates of obesity in the Western World, it is well established that poor weight profiles, and particularly abdominal obesity, is strongly associated with Type II diabetes and cardiovascular diseases. Whether these associations are apparent in ethnic population groups in Scotland is unclear. The purpose of this study was to examine the associations between different measures of fatness with clustered cardio metabolic risk factors between Scottish South Asian adolescents and Scottish Caucasian adolescents; (2) Methods: A sample of 208 Caucasian adolescents and 52 South Asian adolescents participated in this study. Stature, waist circumference, body mass index, blood pressure, physical activity, and cardiovascular disease (CVD) risk were measured; (3) Results: Significant, partial correlations in the South Asian cohort between body mass index (BMI) and individual risk factors were generally moderate. However, correlations between Waist circumference (WC) and individual risk factors were significant and strong. In the Caucasian cohort, a significant yet weak correlation between WC and total cholesterol (TG) was noted although no other associations were evident for either WC or BMI. Multiple regression analysis revealed that both BMI and WC were positively associated with CCR (p < 0.01) in the South Asian group and with the additional adjustment of either WC or BMI, the independent associations with clustered cardio-metabolic risk (CCR) remained significant (p < 0.005); (4) Conclusions: No positive relationships were found between BMI, WC, and CCR in the Caucasian group. Strong and significant associations between measures of fatness and metabolic risk were evident in Scottish South Asian adolescents.

scholarly journals Eating behavior affects cardio-metabolic risk in high school teenagers in a developing country

2020 ◽  
Vol 29 (1) ◽  
pp. 71-81
Author(s):  
Rita Suhadi ◽  
Phebe Hendra ◽  
Dita Maria Virginia ◽  
Christianus Heru Setiawan
Keyword(s):  
Risk Factors ◽  
Heart Rate ◽  
Waist Circumference ◽  
Eating Behavior ◽  
Eating Behaviors ◽  
Metabolic Risk Factors ◽  
Metabolic Risk ◽  
Cross Sectional ◽  
Male Subjects ◽  
Female Subjects

BACKGROUND Modernization negatively changes lifestyle, characterized by excessive eating and reduced energy consumption, and concurrently increases the cardiometabolic risk. This study was aimed to evaluate the association between eating behavior and cardio-metabolic risk factors including body mass index (BMI) in percentile, blood pressure (BP) in percentile, waist circumference, and heart rate in total subjects and gender sub-groups. METHODS This analytical cross-sectional study was done from July to November 2018. High schools in four provinces of Indonesia and students were selected using purposive sampling. Subjects’ profiles were collected from interview and cardio-metabolic parameters were measured at the study sites. Data were analyzed with chi-square and independent t-test. RESULTS Subjects who were overweight/obese and had high BP accounted for 27.1% and 9.3–12.0% of the total subjects (n = 768), respectively. Subjects who having breakfast tended to have lower BMI (p = 0.006), and the lower consumption of western meals had lower heart rate (p = 0.02). Male subjects had more meal frequency and had less quantity of snacks than female subjects (p<0.001). Male subjects with routine intake of vegetables had low heart rate (p = 0.03). Female subjects with routine breakfast had better BMI (p<0.001), and lower diastolic BP (p = 0.004) and waist circumference (p = 0.02), whereas those who consumed Western meals had higher heart rate (p = 0.046) and waist circumference (p = 0.001). CONCLUSIONS Eating behaviors are likely to affect cardio-metabolic risk factors, and the effects vary within gender groups.

Abstract 5063: Cardiovascular Effects of Transdermal Testosterone in Postmenopausal Women

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
C Vitale ◽  
P Collins ◽  
G Marazzi ◽  
G Caminiti ◽  
I Lodhi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Trials ◽  
Hormone Replacement ◽  
Cardiovascular Effects ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Double Blind ◽  
Treatment Groups ◽  
Clinical Program ◽  
Large Phase

Testosterone Transdermal Patch (TTP) has been developed for the treatment of postmeno-pausal women (PMW) with hypoactive sexual desire disorder (HSDD). Since the cardiovascular (CV) effects of testosterone in women are still unclear we conducted a pooled analysis of the large phase III clinical program to evaluate the efficacy and safety of 300 μg/day TTP, alone or in association with hormone replacement therapy (HRT), versus placebo in surgical or natural PMW. Design & Methods: A total of 2795 women aged between 26 –70 years (mean age 52(SD=6.8) years) were included in 5 phase III randomized, double-blind, placebo-controlled clinical trials (treatment duration range 24 – 52 weeks) as part of the TTP Clinical program. 4 studies included PMW (natural and surgical, two each respectively) receiving HRT while 1 study was conducted without HRT, in either surgical or natural PMW. Women with known CV disorders were excluded from the studies. Changes from baseline in standard metabolic and CV risk factors were compared. The incidence of stroke, myocardial infarction (MI) and venous thromboembolism (VTE) alone or as a composite CV endpoint was assessed. Results: The 2795 PMW were randomized to receive either placebo (n=1297) or TTP (n=1498). Baseline mean BMI was 27 kg/m2 (SD=5.3 kg/m2) and 56% were naturally menopausal. The demographic and baseline parameters were similar among the treatment groups. No significant changes in CV risk factors (Total Cholesterol, Triglycerides, Insulin, Glucose, Systolic and Diastolic Blood Pressure) were detected during the study period, apart from a blunting of the increases in HDL-C by TTP at 24 and 52 weeks (Placebo 52-week mean change 2.59 mg/dl vs. TTP 52-week mean change 1.20 mg/dl, p<0.005) and of the decrease in LDL-C by TTP at 24 (p<0.05), but not at 52 weeks. During the double-blind (24 weeks), placebo-controlled period of the combined studies, 4 major CV events (2 MIs and 2 strokes) were reported in placebo patients and 3 (2 MIs and 1 stroke) in those receiving TTP. One VTE occurred in a patient receiving TTP and HRT. Conclusion: TTP therapy in these clinical trials did not adversely affect CV risk profile and did not change the risk of major CV events in these surgical and naturally PMW with or without concomitant HRT.

scholarly journals Efficacy and Safety of Oritavancin Relative to Vancomycin for Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in the Outpatient Setting: Results From the SOLO Clinical Trials

2017 ◽  
Vol 4 (1) ◽  
Author(s):  
Thomas P. Lodise ◽  
Mark Redell ◽  
Shannon O. Armstrong ◽  
Katherine A. Sulham ◽  
G. Ralph Corey
Keyword(s):  
Clinical Trials ◽  
Composite Endpoint ◽  
Outpatient Setting ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
Skin Structure ◽  
Efficacy Outcome ◽  
End Of Treatment ◽  
Secondary Endpoints

Abstract Background The objective of this analysis was to evaluate the efficacy and safety of oritavancin compared with vancomycin for patients with acute bacterial skin and skin structure infections (ABSSSIs) who received treatment in the outpatient setting in the Phase 3 SOLO clinical trials. Methods SOLO I and SOLO II were 2 identically designed comparative, multicenter, double-blind, randomized studies to evaluate the efficacy and safety of a single 1200-mg dose of intravenous (IV) oritavancin versus 7–10 days of twice-daily IV vancomycin for the treatment of ABSSSI. Protocols were amended to allow enrolled patients to complete their entire course of antimicrobial therapy in an outpatient setting. The primary efficacy outcome was a composite endpoint (cessation of spread or reduction in size of the baseline lesion, absence of fever, and no rescue antibiotic at early clinical evaluation [ECE]) (48 to 72 hours). Key secondary endpoints included investigator-assessed clinical cure 7 to 14 days after end of treatment (posttherapy evaluation [PTE]) and 20% or greater reduction in lesion area at ECE. Safety was assessed until day 60. Results Seven hundred ninety-two patients (oritavancin, 392; vancomycin, 400) received entire course of treatment in the outpatient setting. Efficacy response rates at ECE and PTE were similar (primary composite endpoint at ECE: 80.4% vs 77.5% for oritavancin and vancomycin, respectively) as was incidence of adverse events. Five patients (1.3%) who received oritavancin and 9 (2.3%) vancomycin patients were subsequently admitted to a hospital. Conclusions Oritavancin provides a single-dose alternative to multidose vancomycin for treatment of ABSSSI in the outpatient setting.

scholarly journals Examining associations between dietary patterns and metabolic CVD risk factors: a novel use of structural equation modelling

2016 ◽  
Vol 115 (9) ◽  
pp. 1586-1597 ◽  
Author(s):  
Michelle Alessandra Castro ◽  
Valéria Troncoso Baltar ◽  
Dirce Maria Marchioni ◽  
Regina Mara Fisberg
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Body Weight ◽  
Cardiovascular Risk ◽  
Waist Circumference ◽  
Cardiovascular Risk Factors ◽  
Dietary Patterns ◽  
Structural Equation ◽  
Cholesterol Ratio ◽  
Equation Modelling

AbstractThe association between dietary patterns and metabolic cardiovascular risk factors has long been addressed but there is a lack of evidence towards the effects of the overall diet on the complex net of biological inter-relationships between risk factors. This study aimed to derive dietary patterns and examine their associations with metabolic cardiovascular risk factors following a theoretic model for the relationship between them. Participants included 417 adults of both sexes, enrolled to the cross-sectional population-based study performed in Brazil. Body weight, waist circumference, high-sensitivity C-reactive protein, blood pressure, total cholesterol:HDL-cholesterol ratio, TAG:HDL-cholesterol ratio, fasting plasma glucose and serum leptin were evaluated. Food consumption was assessed by two non-consecutive 24-h dietary recalls adjusted for the within-person variation of intake. A total of three dietary patterns were derived by exploratory structural equation modelling: ‘Traditional’, ‘Prudent’ and ‘Modern’. The ‘Traditional’ pattern had a negative and direct effect on obesity indicators (serum LEP, body weight and waist circumference) and negative indirect effects on total cholesterol:HDL-cholesterol ratio, TAG:HDL-cholesterol ratio and fasting plasma glucose. The ‘Prudent’ pattern had a negative and direct effect on systolic blood pressure. No association was observed for the ‘Modern’ pattern and metabolic risk factors. In conclusion, the ‘Traditional’ and ‘Prudent’ dietary patterns were negatively associated with metabolic cardiovascular risk factors among Brazilian adults. Their apparent protective effects against obesity and high blood pressure may be important non-pharmacological strategies for the prevention and control of obesity-related metabolic disorders and CVD.

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