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Biomedical subjects

John L Sievenpiper

Publications and source records attributed to John L Sievenpiper.

10 recordsLinked to original sources
PubMed2006

Korean red ginseng (Panax ginseng) improves glucose and insulin regulation in well-controlled, type 2 diabetes: results of a randomized, double-blind, placebo-controlled study of efficacy and safety.

BACKGROUND AND AIM: To address the paucity of randomized clinical studies assessing ginseng on long-term outcomes in type 2 diabetes, we assessed the clinical antidiabetic efficacy and safety of 12 weeks of supplementation with a Korean red ginseng (KRG) preparation, dose, and mode of administration, selected from an acute, clinical, screening model. METHODS AND RESULTS: Nineteen participants with well-controlled type 2 diabetes (sex: 11 M:8 F, age: 64+/-2 years, BMI: 28.9+/-1.4 kg/m(2), HbA(1c): 6.5%) completed the study. Using a double-blind, randomized, crossover design, each participant received the selected KRG preparation (rootlets) and placebo at the selected dose (2 g/meal=6 g/day) and mode of administration (preprandial oral agent [-40 min]) for 12 weeks as an adjunct to their usual anti-diabetic therapy (diet and/or medications). Outcomes included measures of efficacy (HbA1c and fasting- and 75-g oral glucose tolerance test [OGTT]-plasma glucose [PG], plasma insulin [PI], and insulin sensitivity index [ISI] indices); safety (liver, kidney, haemostatic, and blood-pressure function); and compliance (returned capsules, diet-records, and body-weight). There was no change in the primary endpoint, HbA(1c). The participants, however, remained well-controlled (HbA1c=6.5%) throughout. The selected KRG treatment also decreased 75 g-OGTT-PG indices by 8-11% and fasting-PI and 75 g-OGTT-PI indices by 33-38% and increased fasting-ISI (homeostasis model assessment [HOMA]) and 75 g-OGTT-ISI by 33%, compared with placebo (P<0.05). Safety and compliance outcomes remained unchanged. CONCLUSIONS: Although clinical efficacy, as assessed by HbA1c, was not demonstrated, 12 weeks of supplementation with the selected KRG treatment maintained good glycemic control and improved PG and PI regulation safely beyond usual therapy in people with well-controlled type 2 diabetes. Further investigation with similarly selected KRG treatments may yield clinical efficacy.

Administration, Oral↗
PubMed2006

Long-term intake of North American ginseng has no effect on 24-hour blood pressure and renal function.

Ginseng is consumed by 10% to 20% of adults in Asia and by up to 5% in Western countries. Despite observational evidence suggesting a link between its intake and the development of hypertension, there remains no long-term scrutiny for its effect on blood pressure (BP). We therefore undertook a randomized, placebo-controlled, double-blinded, crossover trial in 52 hypertensive individuals to determine the effect of 12-week North American ginseng intake on 24-hour BP; we also measured serum cystatin C as a marker of renal function. After a 4-week placebo run-in, we randomly assigned 52 participants to 3 g/day of ginseng or placebo for 12 weeks. This was followed by an 8-week washout and a subsequent 12-week period in which the opposite treatment was administered. At run-in and at weeks 0 and 12 of each treatment period, participants were fitted with an ambulatory BP monitor to assess 24-hour BP. The primary outcome was the treatment difference at week 12 in mean 24-hour systolic BP. Secondary outcomes were treatment differences at week 12 in other ambulatory BP parameters and serum cystatin C. Forty participants (77%) completed the trial, with 3 removed from main analysis (n=2, antihypertensive drug changes; n=1, incomplete ambulatory monitoring). In the remaining 37, 12-week ginseng treatment was associated with a neutral effect on all ambulatory BP parameters compared with placebo; an intention-to-treat analysis supported this. Ginseng did not affect serum cystatin C level. Overall, long-term ginseng use had no effect on 24-hour BP and renal function in hypertensive individuals.

Blood Pressure↗
PubMed2006

Korean red ginseng rootlets decrease acute postprandial glycemia: results from sequential preparation- and dose-finding studies.

BACKGROUND: Fractionation of a ginseng source to produce differences in the ginsenoside profile might influence its effect on postprandial glycemia. To explore this possibility and identify an efficacious ginseng for a longterm study, we conducted a preparation-finding study of different Korean red ginseng (KRG) root fractions followed by a dose-finding study of the most efficacious fraction. METHODS: A double-blind, randomized, within-subject design was used in both studies. In the preparation-finding study, 7 healthy subjects (sex: 3m:4f, age: 32 +/- 4 y, BMI: 24 +/- 2 kg/m2) received 6 g placebo and KRG-rootlets, -body, and -H2O extract 40 min before a 50 g-OGTT with finger-prick blood samples at -40-, 0-, 15-, 30-, 45-, 60-, 90-, 120-min. In the dose-finding study, 12 healthy subjects (sex: 9M,3F, age: 29 +/- 3 y, BMI: 22.5 +/- 1 kg/m2) received 0 g (placebo), 2 g, 4 g, and 6 g of the most efficacious root fraction following the same protocol. Ginsenosides were analyzed using HPLC-UV. RESULTS: In the preparation-finding study, a wide variation in the ginsenoside profiles was achieved across the 3 KRG fractions. This variation coincided with differential effects. The main effects of KRG-rootlets (p = 0.050) and time (p < 0.001) and their interaction (p < 0.1) were significant. This was reflected in a 29% reduction in area under the curve (AUC) by KRG-rootlets compared with placebo (p = 0.052). Conversely, neither KRG-H2O extract nor KRG-body affected glycemia. Stepwise-multiple regression models identified Rg1 as the sole predictor of mean- and AUC postprandial blood glucose. In the dose-finding study, KRG-rootlets were tested as the most efficacious fraction. A significant effect of KRG-rootlets treatment (mean of 3 doses) but not dose was found. The mean of 3 doses decreased AUC by 17% compared with placebo (p = 0.057). CONCLUSIONS: Together the studies indicate 2 g KRG-rootlets is sufficient to achieve reproducible reductions in postprandial glycemia. But the longterm sustainability of KRG selected using this approach remains to be tested.

Adult↗
PubMed2005

Herbal remedies in the management of diabetes: lessons learned from the study of ginseng.

The only example of an approved antidiabetic drug that was developed from a herbal source with a long history of use for diabetes is the biguanide Metformin from French lilac (Galega officinalis). Clinical data are beginning to emerge that support antidiabetic indications for several other herbs. This viewpoint discusses the state of the evidence for their clinical antidiabetic efficacy. One of the most studied herbs, ginseng (Panax spp.), is used as a model to illustrate the challenges associated with achieving reproducible clinical efficacy. It is concluded that the best evidence for clinical efficacy in diabetes remains for ginseng. But overall insufficient evidence exists to claim a diabetes indication for herbs. The experience with ginseng suggests that although reproducible efficacy may be achieved using an acute postprandial clinical screening model to select an efficacious ginseng batch, dose, and time of administration, there is a need to develop a basis for standardization that ties the composition of herbs to efficacy. In absence of such standardization, the use of herbs in diabetes must be approached cautiously.

Complementary Therapies↗
PubMed2004

Decreasing, null and increasing effects of eight popular types of ginseng on acute postprandial glycemic indices in healthy humans: the role of ginsenosides.

BACKGROUND: It is unclear whether other ginseng sources can replicate the glycemic-lowering efficacy observed previously with American ginseng and whether ginsenosides are mediators. We assessed the effect of eight popular ginseng types on postprandial plasma glucose (PG) and insulin (PI) indices, linking effects to ginsenoside profiles. METHODS: Using a double-blind, randomized, multiple-crossover design, 12 healthy participants (gender: 6M:6F, age: 34 +/- 3 y, BMI: 25.8 +/- 1.2 kg/m(2)) received 10 3g treatments: American, American-wild, Asian, Asian-red, Vietnamese-wild, Siberian, Japanese-rhizome, and Sanchi ginsengs and two placebos. Each treatment was given 40-minutes before a 75g-oral-glucose-tolerance-test (75g-OGTT) with blood drawn at -40, 0, 15, 30, 45, 60, 90, 120-minutes. HPLC-UV analysis quantified seven principal ginsenosides. RESULTS: Two-factor analysis showed the main effects of ginseng-type and time were significant for PG and PI, with an interaction for PG (p < 0.05). Subsequent one-factor analysis showed an effect of ginseng-type on 90-min-PG and 90-min-PI (p < 0.05). This was reflected in effects on peak-PG, area under the curve (AUC)-PG and AUC-PI (p < 0.05). But the effect on 90-min-PI and AUC-PI were significant (p < 0.05) only in overweight participants (BMI > 25 kg/m(2), n = 6). Planned comparisons with placebo showed a tendency for American ginseng and Vietnamese ginseng to lower 90-min-PG (p < 0.06), while Asian ginseng raised peak-PG and AUC-PG, American-wild ginseng raised 120-min-PG, and Siberian ginseng raised 90-min-PG, 120-min-PG, and AUC-PG (p < 0.05). Stepwise-multiple-regression assessed the protopanaxadiol:protopanaxatriol (PPD:PPT)-ginsenoside ratio as the sole predictor (p < 0.05) for 90-min-PG (beta = -0.43, r(2) = 0.072), AUC-PG (beta = -0.25, r(2) = 0.06), 90-min-PI (beta = -0.26, r(2) = 0.065), AUC-PI (beta = -0.20, r(2) = 0.04). CONCLUSIONS: Ginseng has variable glycemic effects, in which the PPD:PPT-ginsenoside ratio might be involved. But the low variance explained suggests the involvement of other unmeasured ginsenoside or non-ginsenoside components.

Acute Disease↗
PubMed2003

Null and opposing effects of Asian ginseng (Panax ginseng C.A. Meyer) on acute glycemia: results of two acute dose escalation studies.

OBJECTIVE: We have repeatedly reported that a batch of American ginseng with a specific ginsenoside (glycosidal saponin) profile decreases acute postprandial glycemia. We investigated whether Asian ginseng is able to replicate this glycemia-lowering efficacy in two separate acute dose escalation studies. METHODS: Each study was conducted in a separate sample of 11 healthy subjects (gender: 8M:3F and 6M:5F, age: 29 +/- 2y and 27 +/- 3y, BMI: 28.5 +/- 2.1 kg/m(2) and 26.9 +/- 1.4 kg/m(2)) using a randomized, single-blind, placebo-controlled, multiple-crossover design. Treatments consisted of 0 (placebo), 1, 2, and 3 g of Asian ginseng for the first study and 0 (placebo), 3, 6, and 9 g Asian ginseng for the second study administered 40 minutes before a 75g-OGTT protocol with blood drawn at -40, 0, 15, 30, 45, 60, 90, and 120 minutes. Ginsenosides were analyzed by HPLC-UV. RESULTS: Neither the main effect of pooled-treatment, nor dose, nor either factors interaction with time was significant for incremental plasma glucose and insulin. But the diagnostically and therapeutically relevant two-hour plasma glucose (2h-PG) value was significantly higher for pooled Asian ginseng treatment than placebo (5.46 +/- 0.31 versus 4.99 +/- 0.30 mmol/L, p = 0.050). Ginsenoside analyses showed that the Asian ginseng contained up to 96% lower and sevenfold higher quantities of various ginsenosides and their ratios than our previous efficacious batch of American ginseng. CONCLUSIONS: Asian ginseng showed both null and opposing effects on indices of acute postprandial plasma glucose and insulin. This is in contrast to our findings with American ginseng. One explanation may be the marked ginsenoside differences. Practitioners and consumers should be aware of ginseng's variable effects.

Acute Disease↗
PubMed2003

Fat versus carbohydrate in insulin resistance, obesity, diabetes and cardiovascular disease.

PURPOSE OF REVIEW: This review assesses the relative effect of fat versus carbohydrate and the differences between fatty acids and types of carbohydrate on insulin resistance and associated risk factors for diabetes and cardiovascular disease. RECENT FINDINGS: The debate continues over whether high-carbohydrate or high-fat diets have the more deleterious metabolic effects. Large randomized controlled trials have shown that a reduction of fat intake as part of a healthy lifestyle combined with weight reduction and exercise reduce the risk of type 2 diabetes. Carbohydrate as fruit and vegetable together with low-fat dairy products reduce blood pressure. The results of trials of fatty acid type continue to favor the use of monounsaturated fats. However, the advantages over carbohydrate have not always been clear. In terms of carbohydrate, the glycemic index appears to be a better predictor of the metabolic effects of a diet than the sugar content. The fiber content of the carbohydrate food appears to confer benefits in terms of diabetic control. Lower cholesterol and postprandial blood glucose results are associated with viscous fibers. SUMMARY: Diets that are higher in monounsaturated fatty acids, fiber and low glycemic index foods appear to have advantages in insulin resistance, glycemic control and blood lipids in a number of studies. The division of nutrients into total fat (regardless of fatty acids) versus carbohydrate (type and quantity not specified) appears to be less helpful in predicting outcomes.

Blood Glucose↗
PubMed2002

Insulin resistance: concepts, controversies, and the role of nutrition.

Insulin resistance is a prevalent condition, in which insulin loses its normal physiological action. Since people were first classified as insulin resistant over 60 years ago, one of the main discoveries has been that insulin resistance clusters with other risk factors such as obesity, elevated triglycerides, and low high-density lipoprotein cholesterol, increasing cardiovascular disease risk. Although insulin resistance appears to manifest first in the periphery and then in the liver, other sites, such as the brain and the pancreatic &b.beta-cell, may play pathogenic roles. Factors contributing to insulin resistance at these sites include perturbations in free fatty acids, glucose, and hormone-signalling, some of which may be linked to various genetic polymorphisms. Appropriate nutritional treatment for insulin resistance is controversial. Two main approaches are drawn from diabetes recommendations: i) a high-carbohydrate, low-fat, high-fibre diet emphasizing low glycemic-index foods and ii) sharing calories between monounsaturated fat and complex carbohydrate at the expense of saturated fat. Recent interest in insulin resistance has prompted the development of new guidelines. Promising data have also emerged, showing that a high-carbohydrate, high-fibre, low-fat diet plus exercise programs maintained through intensive counselling can decrease diabetes risk by over 40%. Additional research is required to confirm the sustainability of this approach and sort out the determinants of insulin resistance so that more effective nutritional interventions will result.

Blood Glucose↗