Are all fibres created equal with respect to lipid lowering? Comparing the effect of viscous dietary fibre to non-viscous fibre from cereal sources: a systematic review and meta-analysis of randomised controlled trials.

Although compelling evidence from observational studies supports a positive association between consumption of cereal fibre and CVD risk reduction, randomised controlled trials (RCT) often target viscous fibre type as the prospective contributor to lipid lowering to reduce CVD risk. The objective of our study is to compare the lipids-lowering effects of viscous dietary fibre to non-viscous, cereal-type fibre in clinical studies. RCT that evaluated the effect of viscous dietary fibre compared with non-viscous, cereal fibre on LDL cholesterol and alternative lipid markers, with a duration of ≥ 3 weeks, in adults with or without hypercholesterolaemia were included. Medline, EMBASE, CINAHL and the Cochrane Central Register were searched through October 19, 2021. Data were extracted and assessed by two independent reviewers. The generic inverse variance method with random effects model was utilised to pool the data which were expressed as mean differences (MD) with 95 % CI. Eighty-nine trials met eligibility criteria (n 4755). MD for the effect of viscous dietary fibre compared with non-viscous cereal fibre were LDL cholesterol (MD = -0·26 mmol/l; 95 % CI: -0·30, -0·22 mmol/l; P < 0·01), non-HDL cholesterol (MD = -0·33 mmol/l; 95 % CI: -0·39, -0·28 mmol/l; P < 0·01) and Apo-B (MD = -0·04 g/l; 95 % CI: -0·06, -0·03 g/l; P < 0·01). Viscous dietary fibre reduces LDL cholesterol and alternative lipid markers relative to the fibre from cereal sources, hence may be a preferred type of fibre-based dietary intervention targeting CVD risk reduction.

Co-administration of viscous fiber, Salba-chia and ginseng on glycemic management in type 2 diabetes: a double-blind randomized controlled trial.

PURPOSE: Viscous dietary fiber, functional seeds and ginseng roots have individually been proposed for the management of diabetes. We explored whether their co-administration would improve glycemic control in type 2 diabetes beyond conventional therapy. METHODS: In a randomized, double-blind, controlled trial conducted at two academic centers (Toronto, Canada and Zagreb, Croatia), individuals with type 2 diabetes were assigned to either an active intervention (10 g viscous fiber, 60 g white chia seeds, 1.5 g American and 0.75 g Korean red ginseng extracts), or energy and fiber-matched control (53 g oat bran, 25 g inulin, 25 g maltodextrose and 2.25 g wheat bran) intervention for 24 weeks, while on conventional standard of care. The prespecified primary endpoint was end difference at week 24 in HbA1c, following an intent-to-treat analysis adjusted for center and baseline. RESULTS: Between January 2016 and April 2018, 104 participants (60M:44F; mean ± SEM age 59 ± 0.8 years; BMI 29.0 ± 0.4 kg/m2; HbA1c 7.0 ± 0.6%) managed with antihyperglycemic agent(s) (n = 98) or lifestyle (n = 6), were randomized (n = 52 test; n = 52 control). At week 24, HbA1c levels were 0.27 ± 0.1% lower on test compared to control (p = 0.03). There was a tendency towards an interaction by baseline HbA1c (p = 0.07), in which a greater reduction was seen in participants with baseline HbA1c > 7% vs ≤ 7% (- 0.56 ± 0.2% vs 0.03 ± 0.2%). Diet and body weight remained unchanged. The interventions were well tolerated with no related adverse events and with high retention rate of 84%. CONCLUSIONS: Co-administration of selected dietary and herbal therapies was well-tolerated and may provide greater glycemic control as add-on therapy in type 2 diabetes. Registration: Clinicaltrials.gov NCT02553382 (registered on September 17, 2015).

Effect of viscous fiber supplementation on obesity indicators in individuals consuming calorie-restricted diets: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Dietary fiber has played a consistent role in weight management, with efficacy potentially attributed to increased viscous fiber consumption. PURPOSE: To summarize the effects of viscous fiber on body weight and other anthropometric parameters, along with a calorie-deficient diet, through a systematic review and meta-analysis. METHODS: MEDLINE, EMBASE, and the Cochrane library were searched through July 24, 2019 for randomized controlled trials that assessed the effect of viscous fiber supplementation as part of a restricted calorie diet for ≥ 4 weeks relative to comparator diets. Data were pooled using the generic inverse-variance method with random-effects models and expressed as mean differences with 95% confidence intervals. Inter-study heterogeneity was assessed using Cochran's Q and quantified with I2. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to evaluate the overall certainty of evidence. RESULTS: Findings from 15 studies (n = 1347) showed viscous fiber supplementation significantly decreased body weight (- 0.81 kg [- 1.20, - 0.41]; p < 0.0001), BMI (- 0.25 kg/m2 [- 0.46, - 0.05]; p = 0.01), and body fat (- 1.39% [- 2.61, - 0.17]; p = 0.03), compared to control. No effect on waist circumference was found. The certainty of evidence was graded as "moderate" for body weight, BMI, and body fat based on downgrades for imprecision. Waist circumference was graded "low" for downgrades of inconsistency and imprecision. CONCLUSION: Viscous fiber within a calorie-restricted diet significantly improved body weight and other markers of adiposity in overweight adults and those with additional risk factors for cardiovascular disease. This trial is registered at www.clinicaltrials.gov as NCT03257449. REGISTRATION: ClinicalTrials.gov identifier: NCT03257449.

Efficacy and safety of American ginseng (Panax quinquefolius L.) extract on glycemic control and cardiovascular risk factors in individuals with type 2 diabetes: a double-blind, randomized, cross-over clinical trial.

PURPOSE: Despite the lack of evidence, a growing number of people are using herbal medicine to attenuate the burden of diabetes. There is an urgent need to investigate the clinical potential of herbs. Preliminary observations suggest that American ginseng (Panax quinquefolius [AG]) may reduce postprandial glycemia. Thus, we aimed to evaluate the efficacy and safety of AG as an add-on therapy in individuals with type 2 diabetes (T2DM) controlled by conventional treatment. METHODS: 24 individuals living with T2DM completed the study (F:M = 11:13; age = 64 ± 7 year; BMI = 27.8 ± 4.6 kg/m2; HbA1c = 7.1 ± 1.2%). Utilizing a double-blind, cross-over design, the participants were randomized to receive either 1 g/meal (3 g/day) of AG extract or placebo for 8 weeks while maintaining their original treatment. Following a ≥ 4-week washout period, the participants were crossed over to the opposite 8-week treatment arm. The primary objective was HbA1c, and secondary endpoints included fasting blood glucose and insulin, blood pressure, plasma lipids, serum nitrates/nitrites (NOx), and plasominogen-activating factor-1 (PAI-1). Safety parameters included liver and kidney function. RESULTS: Compared to placebo, AG significantly reduced HbA1c (- 0.29%; p = 0.041) and fasting blood glucose (- 0.71 mmol/L; p = 0.008). Furthermore, AG lowered systolic blood pressure (- 5.6 ± 2.7 mmHg; p < 0.001), increased NOx (+ 1.85 ± 2.13 µmol/L; p < 0.03), and produced a mean percent end-difference of - 12.3 ± 3.9% in LDL-C and - 13.9 ± 5.8% in LDL-C/HDL. The safety profiles were unaffected. CONCLUSIONS: AG extract added to conventional treatment provided an effective and safe adjunct in the management of T2DM. Larger studies using physiologically standardized ginseng preparations are warranted to substantiate the present findings and to demonstrate therapeutic effectiveness of AG. CLINICALTRIALS. GOV IDENTIFIER: NCT02923453.

The effects of gelled konjac glucomannan fibre on appetite and energy intake in healthy individuals: a randomised cross-over trial.

Konjac glucomannan (KGM) is a viscous dietary fibre that can form a solid, low-energy gel when hydrated and is commonly consumed in a noodle form (KGM-gel). Increased meal viscosity from gel-forming fibres have been associated with prolonged satiety, but no studies to date have evaluated this effect with KGM-gel. Thus, our objective was to evaluate subsequent food intake and satiety of KGM-gel noodles when replacing a high-carbohydrate preload, in a dose-response manner. Utilising a randomised, controlled, cross-over design, sixteen healthy individuals (twelve females/four males; age: 26·0 (sd 11·8) years; BMI: 23·1 (sd 3·2) kg/m2) received 325 ml volume-matched preloads of three KGM-gel noodle substitution levels: (i) all pasta with no KGM-gel (1849 kJ (442 kcal), control), half pasta and half KGM-gel (1084 kJ (259 kcal), 50-KGM) or no pasta and all KGM-gel (322 kJ (77 kcal), 100-KGM). Satiety was assessed over 90 min followed by an ad libitum dessert. Compared with control, cumulative energy intake was 47 % (-1761 kJ (-421 kcal)) and 23 % (-841 kJ (-201 kcal)) lower for 100-KGM and 50-KGM, respectively (both P<0·001), but no differences in subsequent energy intake was observed. Ratings of hunger were 31 % higher (P=0·03) for 100-KGM when compared with control, and were 19 % lower (P=0·04) for fullness and 28 % higher (P=0·04) for prospective consumption when comparing 100-KGM to 50-KGM. Palatability was similar across all treatments. Replacement of a high-carbohydrate preload with low-energy KGM-gel noodles did not promote additional food intake despite large differences in energy. The energy deficit incurred from partial KGM-gel substitution may have relevance in weight loss regimens, and should be further evaluated beyond the healthy population.

Co-administration of a konjac-based fibre blend and American ginseng (Panax quinquefolius L.) on glycaemic control and serum lipids in type 2 diabetes: a randomized controlled, cross-over clinical trial.

PURPOSE: Use of polypharmacy in the treatment of diabetes is the norm; nonetheless, optimal control is often not achieved. Konjac-glucomannan-based fibre blend (KGB) and American ginseng (AG) have individually been shown to improve glycaemia and CVD risk factors in type 2 diabetes. The aim of this study was to determine whether co-administration of KGB and AG could improve diabetes control beyond conventional treatment. METHOD: Thirty-nine participants with type 2 diabetes (6.5 > A1c < 8.4%) were enrolled between January 2002 and May 2003 at the Risk Factor Modification Centre at St Michaels Hospital in a randomized, placebo-controlled, crossover trial with each intervention lasting 12-weeks. Medications, diet and lifestyle were kept constant. Interventions consisted of 6 g of fibre from KGB together with 3 g of AG (KGB and AG) or wheat bran-based, fibre-matched control. Primary endpoint was the difference in HbA1c levels at week 12. RESULTS: Thirty participants (18M:12F; age: 64 ± 7 years; BMI: 28 ± 5 kg/m2; HbA1c: 7.0 ± 1.0%) completed the study, and consumed 5.5 and 4.9 g/day of fibre from KGB and wheat bran control, respectively, and 2.7 g/day of AG. At week 12, HbA1c levels were 0.31% lower on the KGB and AG compared to control (p = 0.011). Mean (±SEM) plasma lipids decreased on the KGB and AG vs control by 8.3 ± 3.1% in LDL-C (p = 0.002), 7.5 ± 2.4% in non-HDL-C (p = 0.013), 5.7 ± 1.9% in total-C (p = 0.012), 4.1 ± 2.1% in total-C:HDL-C ratio (p = 0.042), 9.0 ± 2.3% in ApoB (p = 0.0005) and 14.6 ± 4.2% in ApoB:ApoA1 ratio (p = 0.049). CONCLUSIONS: Co-administration of KGB and AG increases the effectiveness of conventional therapy through a moderate but clinically meaningful reduction in HbA1c and lipid concentrations over 12 weeks in patients with type 2 diabetes. CLINICAL TRIALS REGISTRATION: NCT02806349 ( https://clinicaltrials.gov/ ).

The effect of oat ß-glucan on LDL-cholesterol, non-HDL-cholesterol and apoB for CVD risk reduction: a systematic review and meta-analysis of randomised-controlled trials.

Oats are a rich source of ß-glucan, a viscous, soluble fibre recognised for its cholesterol-lowering properties, and are associated with reduced risk of CVD. Our objective was to conduct a systematic review and meta-analysis of randomised-controlled trials (RCT) investigating the cholesterol-lowering potential of oat ß-glucan on LDL-cholesterol, non-HDL-cholesterol and apoB for the risk reduction of CVD. MEDLINE, Embase, CINAHL and Cochrane CENTRAL were searched. We included RCT of ≥3 weeks of follow-up, assessing the effect of diets enriched with oat ß-glucan compared with controlled diets on LDL-cholesterol, non-HDL-cholesterol or apoB. Two independent reviewers extracted data and assessed study quality and risk of bias. Data were pooled using the generic inverse-variance method with random effects models and expressed as mean differences with 95 % CI. Heterogeneity was assessed by the Cochran's Q statistic and quantified by the I 2-statistic. In total, fifty-eight trials (n 3974) were included. A median dose of 3·5 g/d of oat ß-glucan significantly lowered LDL-cholesterol (-0·19; 95 % CI -0·23, -0·14 mmol/l, P<0·00001), non-HDL-cholesterol (-0·20; 95 % CI -0·26, -0·15 mmol/l, P<0·00001) and apoB (-0·03; 95 % CI -0·05, -0·02 g/l, P<0·0001) compared with control interventions. There was evidence for considerable unexplained heterogeneity in the analysis of LDL-cholesterol (I 2=79 %) and non-HDL-cholesterol (I 2=99 %). Pooled analyses showed that oat ß-glucan has a lowering effect on LDL-cholesterol, non-HDL-cholesterol and apoB. Inclusion of oat-containing foods may be a strategy for achieving targets in CVD reduction.

Randomized clinical trial in healthy individuals on the effect of viscous fiber blend on glucose tolerance when incorporated in capsules or into the carbohydrate or fat component of the meal.

BACKGROUND/OBJECTIVE: Addition of viscous fiber to foods has been shown to significantly reduce postprandial glucose excursions. However, palatability issues and the variability in effectiveness due to different methods of administration in food limits it use. This study explores the effectiveness of a viscous fiber blend (VFB) in lowering postprandial glycemia using different methods of incorporation. METHODS: Two acute, randomized, controlled studies were undertaken: Study 1: Twelve healthy individuals (mean ± SD, age: 36 ± 13 years, body mass index [BMI]: 27 ± 4 kg/m(2)) consumed 8 different breakfasts. All meals consisted of 50 g of available carbohydrate from white bread (WB) and 10 g margarine. Zero, 1, 2, or 4 g of the VFB was baked into WB or mixed with the margarine. Study 2: Thirteen healthy individuals (mean ± SD, age: 39 ± 17 years, BMI: 25 ± 5 kg/m(2)) consumed 6 test meals, consisting of 50 g of available carbohydrate from WB. Six capsules containing either cornstarch or VFB were taken at 4 different time points during the glucose tolerance test. After obtaining a fasting finger-prick blood sample, volunteers consumed the test meal over a 10-minute period. Additional blood samples were taken at 15, 30, 45, 60, 90, and 120 minutes from the start of the meal. For study 2, an additional fasting sample was obtained at -30 minutes. RESULTS: Study 1: Irrespective of VFB dose, glucose levels were lower at 30 and 45 minutes when VFB was mixed into the margarine compared to the control (p < 0.05). Incremental areas under the curve were significantly lower compared to control when 4 g of VFB was mixed into the margarine. Study 2: There was no effect of the VFB on postprandial glucose levels when administered in capsules. CONCLUSION: Incorporation of VFB into margarine was more effective in lowering postprandial glycemia than when the VFB was baked into bread and no effect when given in capsules.

Glycemic effect of oat and barley beta-glucan when incorporated into a snack bar: a dose escalation study.

BACKGROUND: The blood glucose-lowering effects of ß-glucan from oats and barley depend on the amounts consumed and their rheological properties. This has been recently challenged with growing evidence that the food matrix may also be an important factor in predicting its physiological response. OBJECTIVE: The objective of this study was to examine the effects of varying doses of ß-glucan from oats and barley and added to a snack bar on postprandial glycemia. DESIGN: In a randomized crossover study, 12 healthy males and females consumed one of 8 snack bars containing 0 (control), 1.5, 3, and 6 g of ß-glucan derived from oats or barley or 3 white bread controls. All treatments contained 50 g of available carbohydrate. Blood glucose concentrations were measured after ingestion of the treatments over 2 hours. RESULTS: Incorporation of 1.5 to 6 g of ß-glucan into snack bars had no additional glucose-lowering benefits irrespective of dose and source compared to the control bars (0 g ß-glucan), suggesting that both the solid food matrix and composition of the bars may play a role in their effects on glycemic response. All bars reduced blood glucose area under the curve (AUC) by an average of 25% (p < 0.05) compared to the mean of the 3 white bread controls. CONCLUSION: Adding ß-glucan from oats and barley to the snack bar formulation used in this study did not yield any additional benefits beyond the glucose-lowering effects of the snack bars themselves.

Effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Evidence from controlled trials encourages the intake of dietary pulses (beans, chickpeas, lentils and peas) as a method of improving dyslipidemia, but heart health guidelines have stopped short of ascribing specific benefits to this type of intervention or have graded the beneficial evidence as low. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction. METHODS: We searched electronic databases and bibliographies of selected trials for relevant articles published through Feb. 5, 2014. We included RCTs of at least 3 weeks' duration that compared a diet emphasizing dietary pulse intake with an isocaloric diet that did not include dietary pulses. The lipid targets investigated were low-density lipoprotein (LDL) cholesterol, apolipoprotein B and non-high-density lipoprotein (non-HDL) cholesterol. We pooled data using a random-effects model. RESULTS: We identified 26 RCTs (n = 1037) that satisfied the inclusion criteria. Diets emphasizing dietary pulse intake at a median dose of 130 g/d (about 1 serving daily) significantly lowered LDL cholesterol levels compared with the control diets (mean difference -0.17 mmol/L, 95% confidence interval -0.25 to -0.09 mmol/L). Treatment effects on apolipoprotein B and non-HDL cholesterol were not observed. INTERPRETATION: Our findings suggest that dietary pulse intake significantly reduces LDL cholesterol levels. Trials of longer duration and higher quality are needed to verify these results. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01594567.

Effect of American ginseng (Panax quinquefolius L.) on glycemic control in type 2 diabetes.

Since diabetes tends to progressively worsen over time, glycemic control often deteriorates in spite of taking regular therapy. Therefore, numerous research studies are by and large focused on finding more efficient therapy, both new medicines for treating type 2 diabetes mellitus, as well as supplements that could serve as an addition to conventional treatment modalities. A variety of herbal preparations have been shown to have modest short-term beneficial effects on glycemia, but of these, the best studied is American ginseng (AG). AG has been shown to be effective in improving glycemic control in type 2 diabetes through increasing post-prandial insulin levels and decreasing postprandial glycemic response. However, high variability in ginsenosides may result in just as high variability in antidiabetic efficacy of over-the-counter ginseng products. Therefore, the availability of standardized extracts of AG could assist greatly in advancing our knowledge on the role of this traditionally used herb and result in a wider application of ginseng product in diabetes management. The aim of this review is to outline the efficacy and safety of American ginseng for AG preparations on glycemic control in patients with type 2 diabetes as well as to increase awareness of the evidence supporting the use of these therapies in diabetes care.

Cardiovascular risk factors, diet and lifestyle among European, South Asian and Chinese adolescents in Canada.

OBJECTIVE: The authors previously reported that adult South Asian immigrants to Canada have an increased risk of cardiovascular disease (CVD) compared to their European and Chinese counterparts. It is unknown whether these ethnic differences also exist among adolescents, and whether they are related to diet and lifestyle. The objective of the present study was to assess the prevalence of CVD risk factors among apparently healthy adolescents in the three largest ethnic population groups in Canada (European, South Asian and Chinese). METHODS: A cross-sectional study among secondary school students in the Greater Toronto Area was undertaken. A total of 203 adolescents from 62 GTA secondary schools were recruited (48% Europeans, 35% Chinese and 18% South Asians) with a mean age of 17.3±1 years; 72% were female. RESULTS: Similar to adults, South Asian adolescents have increased rates of CVD risk factors compared with their European and Chinese peers, including higher prevalence of low high-density lipoprotein levels (P=0.001), high triglycerides (P=0.006) and high triglyceride/high-density lipoprotein levels (P<0.001), despite no significant differences in dietary intake among the ethnic groups. European adolescents had higher rates of self-reported intensity of physical activity (P=0.002) than their Chinese or South Asian peers. CONCLUSIONS: Similar to adult data, South Asian adolescents have comparably higher rates of CVD risk factors compared with their European or Chinese peers, which could partly be attributed to lower physical activity in South Asian adolescents. Whether the findings in these selected samples of healthy adolescents can be generalized to their respective populations requires further validation.

Viscosity rather than quantity of dietary fibre predicts cholesterol-lowering effect in healthy individuals.

The well-documented lipid-lowering effects of fibre may be related to its viscosity, a phenomenon that has been understudied, especially when fibre is given against the background of a typical North American (NA) diet. In this three-arm experiment, we compared the lipid-lowering effect of low-viscosity wheat bran (WB), medium-viscosity psyllium (PSY) and a high-viscosity viscous fibre blend (VFB), as part of a fibre intervention aimed at increasing fibre intake to recommended levels within the context of a NA diet in apparently healthy individuals. Using a randomised cross-over design, twenty-three participants (twelve males and eleven females; age 35 (SD 12) years; LDL-cholesterol (C) 2.9 (SEM 0.6) mmol/l) consuming a typical NA diet received a standard, fibre-enriched cereal, where approximately one-third of the fibre was either a low-viscosity (570 centipoise (cP)) WB, medium-viscosity (14,300 cP) PSY or a high-viscosity (136,300 cP) novel VFB, for 3 weeks separated by washout periods of ≥ 2 weeks. There were no differences among the treatments in the amount of food consumed, total dietary fibre intake, reported physical activity and body weight. Final intake of the WB, PSY and VFB was 10.8, 9.0 and 5.1 g, respectively. Reduction in LDL-C was greater with the VFB compared with the medium-viscosity PSY (-12.6 (SEM 3.5) %, P = 0.002) and low-viscosity WB (-14.6 (SEM 4.2) %, P = 0.003). The magnitude of LDL-C reduction showed a positive association with fibre apparent viscosity (r - 0.41, P = 0.001). Despite the smaller quantity consumed, the high-viscosity fibre lowered LDL-C to a greater extent than lower-viscosity fibres. These data support the inclusion of high-viscosity fibre in the diet to reduce plasma lipids among apparently healthy individuals consuming a typical NA diet.

The jubilees of the discovery of insulin & glycemic index: where conventional meets complementary medicine in the management of diabetes mellitus.

This year we marked two important jubilees in the management of diabetes mellitus: one is the discovery of insulin 90 years ago and the other one is the introduction of the Glycemic Index, 60 years later, both originated at the University of Toronto, Canada. Both discoveries can help to improve diabetes tremendously and thus have contributed to the advancement of management of this troubling disease the incidence of which continues to climb at a staggering rate.

Glycemic index in diabetes.

The Glycemic Index (GI) is a rating system that ranks carbohydrate-containing foods according to their postprandial blood glucose response relative to the same quantity of available carbohydrate of a standard such as white bread or glucose. The concept of GI was first introduced in the early 80's by Jenkins and coworkers. Since then, numerous trials have been undertaken, many indicating benefits of a low GI diet on glycemic control, as well as lipid profiles, insulin and C-peptide levels, inflammatory and thrombolytic factors, endothelial function and regulation of body weight. As a result, a low-GI diet may prevent or delay the vascular complications of diabetes. However, despite many studies supporting the benefits of the Glycemic Index as part of the treatment of diabetes mellitus, several areas of controversy have been raised in the literature and are addressed here. Clinicians treating diabetic patients should be aware of the potential benefits of low-GI foods in the prevention and treatment of diabetes and its complications.

Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial.

BACKGROUND: Diabetes mellitus and hypertension often occur together, amplifying cardiovascular disease (CVD) risk and emphasizing the need for a multitargeted treatment approach. American ginseng (AG) and Korean Red Ginseng (KRG) species could improve glycemic control via complementary mechanisms. Additionally, a KRG-inherent component, ginsenoside Rg3, may moderate blood pressure (BP). Our objective was to investigate the therapeutic potential of coadministration of Rg3-enriched Korean Red Ginseng (Rg3-KRG) and AG, added to standard of care therapy, in the management of hypertension and cardiometabolic risk factors in type-2 diabetes. METHODS: Within a randomized controlled, parallel design of 80 participants with type-2 diabetes (HbA1c: 6.5-8%) and hypertension (systolic BP: 140-160 mmHg or treated), supplementation with either 2.25 g/day of combined Rg3-KRG + AG or wheat-bran control was assessed over a 12-wk intervention period. The primary endpoint was ambulatory 24-h systolic BP. Additional endpoints included further hemodynamic assessment, glycemic control, plasma lipids and safety monitoring. RESULTS: Combined ginseng intervention generated a mean ± SE decrease in primary endpoint of 24-h systolic BP (-3.98 ± 2.0 mmHg, p = 0.04). Additionally, there was a greater reduction in HbA1c (-0.35 ± 0.1% [-3.8 ± 1.1 mmol/mol], p = 0.02), and change in blood lipids: total cholesterol (-0.50 ± 0.2 mmol/l, p = 0.01), non-HDL-C (-0.54 ± 0.2 mmol/l, p = 0.01), triglycerides (-0.40 ± 0.2 mmol/l, p = 0.02) and LDL-C (-0.35 ± 0.2 mmol/l, p = 0.06) at 12 wks, relative to control. No adverse safety outcomes were observed. CONCLUSION: Coadministration of Rg3-KRG + AG is an effective addon for improving BP along with attaining favorable cardiometabolic outcomes in individuals with type 2 diabetes. Ginseng derivatives may offer clinical utility when included in the polypharmacy and lifestyle treatment of diabetes. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier, NCT01578837.

Vascular effects of combined enriched Korean Red ginseng (Panax Ginseng) and American ginseng (Panax Quinquefolius) administration in individuals with hypertension and type 2 diabetes: A randomized controlled trial.

BACKGROUND: Type 2 diabetes is known to abrogate the vascular response. Combination of two commonly consumed ginseng species, American ginseng (AG) and a Korean Red ginseng (KRG), enriched with ginsensoide Rg3, was shown to concomitantly improve glucemic control and blood pressure. We evaluated the hypothesis that improvements in central hemodynamics, vascular function and stiffness markers are involved in observed benefits of co-administration. METHODS: In this randomized, placebo controlled, two-center trial, patients with type 2 diabetes and hypertension were assigned to either 2.25 g ginsenoside Rg3-enriched KRG&AG co-administration or a control 3 times daily for 12-weeks, treated by standard of care. The effects on central hemodynamics, pulse wave velocity (PWV) and endothelial function over the 12-week administration were analyzed. RESULTS: In intent-to-treat analysis of 80 individuals, a reduction in central systolic BP (-4.69 ±â€¯2.24 mmHg, p = 0.04) was observed with co-administration of Rg3-KRG + AG relative to control at 12-weeks, which was characterized by a decrease in end-systolic pressure (-6.60 ±â€¯2.5 mmHg, p = 0.01) and area under the systolic/diastolic BP curve (-132.80 ±â€¯65.1, p = 0.04, 220.90 ±â€¯91.1, p = 0.02, respectively). There was no significant change in reactive hyperemia index (0.09 ±â€¯0.11, p = 0.44), PWV (-0.40 ±â€¯0.28 %, p = 0.17), and other related pulse wave analysis components. CONCLUSION: Co-administration of complementary ginseng species improved central systolic BP and components of pulse waveform without a direct effect on endothelial function, when added to background pharmacotherapy in individuals with diabetes. These data support potential utility of ginseng for modest blood pressure benefit to broaden its role in diabetes management.

Relation of Different Fruit and Vegetable Sources With Incident Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of Prospective Cohort Studies.

Background Public health policies reflect concerns that certain fruit sources may not have the intended benefits and that vegetables should be preferred to fruit. We assessed the relation of fruit and vegetable sources with cardiovascular outcomes using a systematic review and meta-analysis of prospective cohort studies. Methods and Results MEDLINE, EMBASE, and Cochrane were searched through June 3, 2019. Two independent reviewers extracted data and assessed study quality (Newcastle-Ottawa Scale). Data were pooled (fixed effects), and heterogeneity (Cochrane-Q and I2) and certainty of the evidence (Grading of Recommendations Assessment, Development, and Evaluation) were assessed. Eighty-one cohorts involving 4 031 896 individuals and 125 112 cardiovascular events were included. Total fruit and vegetables, fruit, and vegetables were associated with decreased cardiovascular disease (risk ratio, 0.93 [95% CI, 0.89-0.96]; 0.91 [0.88-0.95]; and 0.94 [0.90-0.97], respectively), coronary heart disease (0.88 [0.83-0.92]; 0.88 [0.84-0.92]; and 0.92 [0.87-0.96], respectively), and stroke (0.82 [0.77-0.88], 0.82 [0.79-0.85]; and 0.88 [0.83-0.93], respectively) incidence. Total fruit and vegetables, fruit, and vegetables were associated with decreased cardiovascular disease (0.89 [0.85-0.93]; 0.88 [0.86-0.91]; and 0.87 [0.85-0.90], respectively), coronary heart disease (0.81 [0.72-0.92]; 0.86 [0.82-0.90]; and 0.86 [0.83-0.89], respectively), and stroke (0.73 [0.65-0.81]; 0.87 [0.84-0.91]; and 0.94 [0.90-0.99], respectively) mortality. There were greater benefits for citrus, 100% fruit juice, and pommes among fruit sources and allium, carrots, cruciferous, and green leafy among vegetable sources. No sources showed an adverse association. The certainty of the evidence was "very low" to "moderate," with the highest for total fruit and/or vegetables, pommes fruit, and green leafy vegetables. Conclusions Fruits and vegetables are associated with cardiovascular benefit, with some sources associated with greater benefit and none showing an adverse association. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT03394339.

Repeated administration of inorganic nitrate on blood pressure and arterial stiffness: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: We aim to synthesize effects of repeated administration (≥3 days) of inorganic nitrate on blood pressure and arterial stiffness measures. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials with at least 3 days treatment of inorganic nitrate on blood pressure and arterial stiffness in individuals with or without elevated cardiovascular disease risk. MEDLINE, EMBASE and the Cochrane Library were searched through 2 July 2019. Two independent reviewers extracted relevant study data. Data were pooled using the generic inverse variance method with random-effects model, and expressed as mean differences with 95% confidence intervals. Certainty in the evidence was assessed using GRADE. RESULTS: Forty-seven trials were included (n = 1101). Administration of inorganic nitrate significantly lowered SBP [mean difference: -2.91 mmHg, 95% confidence interval (95% CI): -3.92 to -1.89, I = 76%], DBP (mean difference: -1.45 mmHg, 95% CI: -2.22 to -0.68, I = 78%], central SBP (mean difference: -1.56 mmHg, 95% CI: -2.62 to -0.50, I = 30%) and central DBP (mean difference: -1.99 mmHg, 95% CI: -2.37 to -1.60, I = 0%). There was no effect on 24-h blood pressure, augmentation index or pulse wave velocity. Certainty in the evidence was graded moderate for central blood pressure, pulse wave velocity and low for peripheral blood pressure, 24-h blood pressure and augmentation index. CONCLUSION: Repeated administration (≥3 days) of inorganic nitrate lower peripheral and central blood pressure. Results appear to be driven by beneficial effects in healthy and hypertensive individuals. More studies are required to increase certainty in the evidence.

Effect of soluble-viscous dietary fibre on coronary heart disease risk score across 3 population health categories: data from randomized, double-blind, placebo-controlled trials.

We applied the Framingham risk equation in healthy, metabolic syndrome, and diabetes populations, following treatment with viscous fibre from konjac-based blend (KBB). KBB yielded reduction in estimated risk score by 16% (1.04 ± 0.03 vs. 0.87 ± 0.04, p < 0.01) in type 2 diabetes, 24% (1.08 ± 0.01 vs. 0.82 ± 0.02, p < 0.01) in metabolic syndrome, and 25% (1.09 ± 0.05 vs. 0.82 ± 0.06, p < 0.01) in healthy individuals. Drivers for decreased risk were improvements in blood cholesterol and systolic blood pressure. The composite coronary heart disease risk across populations was reduced 22% (p < 0.01). Novelty Viscous fibre from konjac-xanthan reduced 10-year relative coronary heart disease using Framingham Risk Score across the glycemic status spectrum.