Reglucol™ - Clinical Trials

I Product Info I Ingredients
I Recommended Use
I Clinical Trials
I Research Brief
I References



Indication: obesity, dysbolism, chronic fatigue, increased glucose level; to increase lean muscle mass in sportsmen.

Actions: helps normalize blood glucose levels, decreases sugar cravings, helps decrease blood cholesterol levels, improves the cardiac muscle nourishment, helps normalize body weight, promotes fat burning.

Ingredients(per one capsule): Chromium (as chromium + GPM™) - 50 mcg; Gymnema sylvestre leaf extract 6:1 (25% gymnemic acids) (equivalent to 1200 mg of crude herb) - 200 mg; Banaba (Lagerstroemia speciosa) leaf extract 20:1 (1% corosolic acid) (equivalent to 320 mg of crude herb) - 16 mg.

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Reglucol™ - Clinical Trials:

Clinical research of Chromium + GPM™ conducted by Northridge Medical Center (Academic division of California University, USA) showed that this form demonstrated the highest bioavailability and effectiveness in comparison with all other known forms of Chromium.




The research indicated that Chromium + GPM™ intake supports the stabilization and even decrease of blood triglyceride level, unlike the other forms, which noticeably increase blood triglyceride level (Fig. 1). Increased blood triglyceride level raises the risk of atherosclerosis development.


The diagram shows that supplemental Chromium + GPM™ intake (represented by the line with diamonds) decreases the blood triglyceride level, at the same time the regular forms of Chromium cause drastic increase in their level (the line with squares).


Chromium is an essential mineral that appears to have a beneficial role in the regulation of insulin action and its effects on carbohydrate, protein and lipid metabolism. Chromium is an important factor for enhancing insulin activity. Studies show that people with type 2 diabetes have lower blood levels of chromium than those without the disease. Insulin resistance is the common denominator in a cluster of cardiovascular disease risk factors. One out of every five Americans has metabolic syndrome. It affects 40% of people in their 60s and 70s. Insulin resistance, with or without the presence of metabolic syndrome, significantly increases the risk of cardiovascular disease. Insulin resistance is present in two serious health problems in women; polycystic ovarian syndrome (PCOS) and gestational diabetes. Several studies have now demonstrated that chromium supplements enhance the metabolic action of insulin and lower some of the risk factors for cardiovascular disease, particularly in overweight individuals. Dietary chromium is poorly absorbed. Chromium levels decrease with age. Supplements containing 200-1,000 mcg chromium as chromium picolinate a day have been found to improve blood glucose control. (3)

In Thailand recently, scientists measured the chromium present in gallstones and bile from patients in three Asian cities. They conc uded that patients from Bangkok had consumed higher levels of chromium than their counterparts in the other locales. Since gallstones may take many months or years to form, they provide an intriguing snapshot of long-term trace metal status. Bangkok residents had lower levels of total cholesterol, triglycerides, and hemoglobin A(1C) (an indicator of uncontrolled blood sugar) than Asians with consistently lower intakes of dietary chromium. (4)

BACKGROUND: Chromium (Cr) potentiates the action of insulin in the cell and improves glucose tolerance after long-term supplementation.
OBJECTIVE: We hypothesized that Cr may also have acute effects and might be beneficial in lowering the glycemic index of a meal.
METHODS: We studied the effects of short-term Cr supplementation using a randomized crossover design. Thirteen apparently healthy, non-smoking young men of normal body mass index performed three trials each separated by one week. Test meals, providing 75 g of available carbohydrates, consisted of white bread with added Cr (400 or 800 microg as Cr picolinate) or placebo.
RESULTS: After addition of 400 and 800 microg Cr incremental area under the curve (AUC) for capillary glucose was 23% (p = 0.053) and 20% (p = 0.054), respectively, lower than after the white bread meal. These differences reached significance if the subjects were divided into responders (n = 10) and non-responders (n = 3). For the responders AUC after 400 and 800 microg Cr was reduced by 36% and 30%, respectively (Placebo 175 +/- 22, Cr400 111 +/- 14 (p < 0.01), Cr800 122 +/- 15 mmol. min/L (p < 0.01)). Glycemia was unchanged after addition of Cr in the non-responders. Responders and non-responders differed significantly in their nutrient intake and eating pattern, and total serum iron concentration tended to be lower in the responder group (p = 0.07). CONCLUSIONS: Acute chromium supplementation showed an effect on postprandial glucose metabolism in most but not all subjects. The response to Cr may be influenced by dietary patterns. (5)

Chromium is an essential nutrient involved in normal carbohydrate and lipid metabolism. The chromium requirement is postulated to increase with increased glucose intolerance and diabetes. The objective of this study was to test the hypothesis that the elevated intake of supplemental chromium is involved in the control of type 2 diabetes. Individuals being treated for type 2 diabetes (180 men and women) were divided randomly into three groups and supplemented with: 1) placebo, 2) 1.92 micromol (100 microg) Cr as chromium picolinate two times per day, or 3) 9.6 micromol (500 microg) Cr two times per day. Subjects continued to take their normal medications and were instructed not to change their normal eating and living habits. HbA1c values improved significantly after 2 months in the group receiving 19.2 pmol (1,000 microg) Cr per day and was lower in both chromium groups after 4 months (placebo, 8.5 +/- 0.2%; 3.85 micromol Cr, 7.5 +/- 0.2%; 19.2 micromol Cr, 6.6 +/- 0.1%). Fasting glucose was lower in the 19.2-micromol group after 2 and 4 months (4-month values: placebo, 8.8 +/- 0.3 mmol/l; 19.2 micromol Cr, 7.1 +/- 0.2 mmol/l). Two-hour glucose values were also significantly lower for the subjects consuming 19.2 micromol supplemental Cr after both 2 and 4 months (4-month values: placebo, 12.3 +/- 0.4 mmo/l; 19.2 micromol Cr, 10.5 +/- 0.2 mmol/l). Fasting and 2-h insulin values decreased significantly in both groups receiving supplemental chromium after 2 and 4 months. Plasma total cholesterol also decreased after 4 months in the subjects receiving 19.2 micromol/day Cr. These data demonstrate that supplemental chromium had significant beneficial effects on HbA1c, glucose, insulin, and cholesterol variables in subjects with type 2 diabetes. The beneficial effects of chromium in individuals with diabetes were observed at levels higher than the upper limit of the Estimated Safe and Adequate Daily Dietary Intake. (6)

Chromium is an essential nutrient involved in the metabolism of glucose, insulin and blood lipids. Suboptimal dietary intake of chromium is associated with increased risk factors associated with diabetes and cardiovascular diseases. Within the past five years, chromium has been shown to improve glucose and related variables in subjects with glucose intolerance and type 1, type 2, gestational and steroid-induced diabetes. Severe neuropathy and glucose intolerance of a patient on total parenteral nutrition, who was receiving currently recommended levels of chromium, were reversed by additional supplemental chromium. Chromium increases insulin binding to cells, insulin receptor number and activates insulin receptor kinase leading to increased insulin sensitivity. Additional studies are urgently needed to elucidate the mechanism of action of chromium and its role in the prevention and control of diabetes. (7)

The aim of this study was to determine the effect of chromium (Cr)- enriched yeast on blood glucose and insulin variables, blood lipids, and blood markers of oxidative stress in persons with type 2 diabetes mellitus (median duration: 3.0 yr). Thirty-six subjects (9 men, 27 women; mean age: 61.3 yr; mean body mass index: 34.33 kg/m2) were supplemented with 400 microg Cr/d as Cr-enriched yeast (n = 19) or placebo (n = 17) for 12 wk in a randomized, double-blind study. The most interesting results were obtained by comparison of the change in the placebo group to the change in the Cr group. The Cr group showed a significantly greater increase in serum Cr compared to the placebo group (p < 0.05). Supplementation with Cr-enriched yeast was associated with a significant decrease in fasting serum glucose compared to placebo (p < 0.01). Blood markers of oxidative stress glutathione peroxidase activity and levels of reduced glutathione were essentially unchanged in the Cr group after 12 wk, but decreased significantly in the placebo group (p < 0.05, p < 0.01, respectively). Serum HbA1c and glycated protein (fructosamine) were essentially unchanged in the Cr group, whereas HbA1c tended to increase in the placebo group (from 6.94% to 7.11%). Fasting serum insulin decreased in both groups, with a greater tendency in the Cr group (-16.5% vs -9.5%). These data suggest that supplementation of well-controlled type 2 diabetics with Cr-enriched yeast is safe and can result in improvements in blood glucose variables and oxidative stress. (8)

Scientists at the Oxford University in England recently demonstrated in laboratory animals that supplemental chromium enhances the activity of neurochemicals associated with mood control. They believe that chromium facilitates the transport of certain amino acids within the brain and central nervous system. Further research into this intriguing effect is pending. (9)

Chemistry and pharmacology of Gymnema sylvestre is reviewed relying on research papers and patent literature. Extracts of this plant are widely used in Australian, Japanese, Vietnamese and Indian folk medicine. Gymnema preparations have a profound action on the modulation of taste, particularly suppressing sweet taste sensations. It is used in the treatment of diabetes mellitus and in food additives against obesity and caries. Anti-allergic, antiviral, lipid lowering and other effects are also reported. From a technological point of view, much efforts have been made to mask the biter taste of Gymnema preparations. (10)

The effectiveness of GS4, an extract from the leaves of Gymnema sylvestre, in controlling hyperglycaemia was investigated in 22 Type 2 diabetic patients on conventional oral anti-hyperglycaemic agents. GS4 (400 mg/day) was administered for 18-20 months as a supplement to the conventional oral drugs. During GS4 supplementation, the patients showed a significant reduction in blood glucose, glycosylated haemoglobin and glycosylated plasma proteins, and conventional drug dosage could be decreased. Five of the 22 diabetic patients were able to discontinue their conventional drug and maintain their blood glucose homeostasis with GS4 alone. These data suggest that the beta cells may be regenerated/repaired in Type 2 diabetic patients on GS4 supplementation. This is supported by the appearance of raised insulin levels in the serum of patients after GS4 supplementation. (11)

College of Osteopathic Medicine, Edison Biotechnology Institute, Department of Chemistry and Biochemistry, The Molecular and Cellular Biology Program, Department of Biological Science and Department of Biomedical Science, Ohio University, USA.
The leaves of Lagerstroemia speciosa (Lythraceae), a Southeast Asian tree more commonly known as banaba, have been traditionally consumed in various forms by Philippinos for treatment of diabetes and kidney related diseases. In the 1990s, the popularity of this herbal medicine began to attract the attention of scientists worldwide. Since then, researchers have conducted numerous in vitro and in vivo studies that consistently confirmed the antidiabetic activity of banaba. Scientists have identified different components of banaba to be responsible for its activity. Using tumor cells as a cell model, corosolic acid was isolated from the methanol extract of banaba and shown to be an active compound. More recently, a different cell model and the focus on the water soluble fraction of the extract led to the discovery of other compounds. The ellagitannin Lagerstroemin was identified as an effective component of the banaba extract responsible for the activity. In a different approach, using 3T3-L1 adipocytes as a cell model and a glucose uptake assay as the functional screening method, Chen et al. showed that the banaba water extract exhibited an insulin-like glucose transport inducing activity. Coupling HPLC fractionation with a glucose uptake assay, gallotannins were identified in the banaba extract as components responsible for the activity, not corosolic acid. Penta-O-galloyl-glucopyranose (PGG) was identified as the most potent gallotannin. A comparison of published data with results obtained for PGG indicates that PGG has a significantly higher glucose transport stimulatory activity than Lagerstroemin. Chen et al. have also shown that PGG exhibits anti-adipogenic properties in addition to stimulating the glucose uptake in adipocytes. The combination of glucose uptake and anti-adipogenesis activity is not found in the current insulin mimetic drugs and may indicate a great therapeutic potential of PGG. (12)

Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan.
Corosolic acid (CRA), a constituent of Banaba leaves, has been reported to exert anti-hypertension, anti-hyperinsulinemia, anti-hyperglycemia, and anti-hyperlipidemia effects as well as to induce anti-inflammatory and anti-oxidative activities. The aim of this study was to investigate the inhibitory effects of CRA on the development of obesity and hepatic steatosis in KK-Ay mice, a genetically obese mouse model. Six-week-old KK-Ay mice were fed a high fat diet for 9 weeks with or without 0.023% CRA. Nine-week CRA treatment resulted in 10% lower body weight and 15% lower total fat (visceral plus subcutaneous fat) mass than in control mice. CRA treatment reduced fasting plasma levels of glucose, insulin, and triglyceride by 23%, 41%, and 22%, respectively. The improved insulin sensitivity in CRA-treated mice may be due on part to the increased plasma adiponectin and white adipose tissue (WAT) AdipoR1 levels. In addition, CRA treatment increased the expression of peroxisome proliferator-activated receptor (PPAR) alpha in liver and PPAR gamma in WAT. This is the first study to show that CRA treatment can contribute to reduced body weight and amelioration of hepatic steatosis in mice fed a high fat diet, due in part to increased expression of PPAR alpha in liver and PPAR gamma in WAT. (13)