Recommended dose:

Adults: Take 2 DRcaps daily, one with the morning meal and one with the evening meal, or as directed by a health care practitioner.

Recommended use or purpose:

• Helps to promote healthy glucose metabolism.
• A factor in the maintenance of good health
• Helps normal growth
• Helps to maintain healthy hair, nails, mucous membranes and/or skin

Cautions and warnings:

• Consult a health care practitioner prior to use if you are pregnant or breastfeeding or have diabetes.
• Consult a health care practitioner for use beyond 4 weeks.
• If you experience sweating, paleness, chills, headache, dizziness and/or confusion, discontinue use and consult a healthcare practitioner (as these may be symptoms of serious low blood sugar) ⁽¹⁾
• If seal around cap is broken or missing do not use.

⁽¹⁾ (Bae et al., 2013; Gullo et al., 2014; Bresciani et al., 2011; Chang et al., 2009)

Nutrient	Single Tablet	Daily Dose
**r-Alpha Lipoic Acid**	300 mg	600 mg
**Biotin**	5 mg	10 mg
**Thiamin**	118.5 mg	237 mg

R-ALPHA LIPOIC ACID (LA)⁽¹⁾

α-Lipoic acid (LA), also known as thioctic acid, is a naturally occurring compound that is synthesized in small amounts by plants and animals, including humans. LA is covalently bound to specific proteins, which function as cofactors for several important mitochondrial enzyme complexes.

In addition to the physiological functions of protein-bound LA, there is increasing scientific and medical interest in potential therapeutic uses of pharmacological doses of free LA. LA contains two thiol (sulfur) groups, which may be oxidized or reduced. The reduced form is known as dihydrolipoic acid (DHLA), while the oxidized form is known as LA. LA also contains an asymmetric carbon, meaning there are two possible optical isomers that are mirror images of each other (R-LA and S-LA). Only the R- isomer is endogenously synthesized and bound to protein: R-LA occurs naturally in foods. Free LA supplements may contain either R-LA or a 50/50 (racemic) mixture of R-LA and S-LA. Gluco-Balance™ contains 100% of the more biologically active r-alpha lipoic acid form.

DISEASE TREATMENT

Diabetes mellitus

Chronically elevated blood glucose levels are the hallmark of diabetes mellitus (DM). In type 1 DM, insulin production is insufficient due to autoimmune destruction of the insulin-producing β-cells of the pancreas. Type 1 DM is also known as insulin-dependent DM because exogenous insulin is required to maintain normal blood glucose levels. In contrast, impaired cellular glucose uptake in response to insulin (insulin resistance) plays a key role in the development of type 2 DM. Although individuals with type 2 DM may eventually require insulin, type 2 DM is also known as non-insulin-dependent DM because interventions that enhance insulin sensitivity may be used to maintain normal blood glucose levels.

Glucose utilization

A placebo-controlled study of 72 patients with type 2 DM found that oral administration of LA at doses of 600 mg/day, 1,200 mg/day or 1,800 mg/day improved insulin sensitivity by 25% after four weeks of treatment. There were no significant differences among the three doses of LA, suggesting that 600 mg/day may be the maximum effective dose. Data from animal studies suggest that the R-isomer of LA may be more effective in improving insulin sensitivity than the S-isomer.

Vascular disease

The inner lining of blood vessels, known as the endothelium, plays an important role in vascular disease. Endothelial function is often impaired in diabetic patients, who are at high risk for vascular disease. Intra-arterial infusion of LA improved endothelium dependent vasodilation in 39 diabetic patients but not in 11 healthy controls. In addition, a randomized, double-blind, placebo-controlled study in 30 patients with type 2 diabetes found that intravenous infusion of 600 mg of LA improved the response to the endothelium-dependent vasodilator acetylcholine, but not to the endothelium-independent vasodilator, glycerol trinitrate. Endothelial function can be assessed non-invasively by using ultrasound to measure flow-mediated vasodilation, which is endothelium-dependent. Using ultrasound, intravenous LA has also been shown to improve endothelial function in patients with impaired fasting glucose or impaired glucose tolerance which are pre-diabetic conditions.

A few studies have investigated whether oral administration of LA might improve vascular function in patients with diabetes or metabolic syndrome. A randomized controlled trial assessed the effect of oral LA supplementation on flow-mediated vasodilation in 58 patients diagnosed with metabolic syndrome, a condition characterized by abnormal glucose and lipid (fat) metabolism . Oral supplementation with 300 mg/day of LA for four weeks improved flow-mediated vasodilation by 44% compared to placebo. Diabetic patients are also at high risk for micro-vascular disease, which may contribute to diabetic neuropathy. In an uncontrolled study, oral supplementation with 1,200 mg/day of LA for six weeks improved a measure of capillary perfusion in the fingers of eight diabetic patients with peripheral neuropathy.

Diabetic neuropathy

More than 20% of diabetic patients develop peripheral neuropathy, a type of nerve damage that may result in pain, loss of sensation, and weakness, particularly in the lower extremities. Peripheral neuropathy is also a leading cause of lower limb amputation in diabetic patients. Chronic hyperglycemia has been linked to peripheral nerve damage; several mechanisms have been proposed to explain the glucose-induced nerve damage, such as intracellular accumulation of sorbitol, glycation reactions, and oxidative and nitrosative stress. The results of several large randomized controlled trials indicate that maintaining blood glucose at near normal levels is the most important step in decreasing the risk of diabetic neuropathy. However, such intensive blood glucose control may not be achievable in all diabetic patients.

Intravenous and oral LA is approved for the treatment of diabetic neuropathy in Germany. A meta-analysis that combined the results of four randomized controlled trials, including 1,258 diabetic patients, found that treatment with 600 mg/day of intravenous LA for three weeks significantly reduced the symptoms of diabetic neuropathy to a clinically meaningful degree.

The efficacy of oral LA in the treatment of diabetic neuropathy is less clear. A short-term study of 24 patients with type 2 diabetes mellitus (DM) found that the symptoms of peripheral neuropathy were improved in those who took 1,800 mg/day of oral LA for three weeks compared to those who took a placebo. More recently, a randomized, double-blind, placebo-controlled trial in 181 patients with diabetic neuropathy found that oral supplementation with 600 mg/day, 1,200 mg/day, or 1,800 mg/day of LA for five weeks significantly improved neuropathic symptoms. In this study, the 600 mg/day dose was as effective as the higher doses.

A much larger clinical trial randomly assigned more than 500 patients with type 2 DM and symptomatic peripheral neuropathy to one of the following treatments:

(1) 600 mg/day of intravenous LA for 3 weeks followed by 1,800 mg/day of oral LA for six months;

(2) 600 mg/day of intravenous LA for three weeks followed by oral placebo for six months;

(3) Intravenous placebo for three weeks followed by oral placebo for six months. Although symptom scores did not differ significantly from baseline in any of the groups, assessments of sensory and motor deficits by physicians improved significantly after three weeks of intravenous LA therapy. Motor and sensory deficits were also somewhat improved at the end of six months of oral LA therapy, but the trend did not reach statistical significance.

In another trial of oral LA therapy, 299 patients with diabetic peripheral neuropathy were randomly assigned to treatment with 1,200 mg/day of LA, 600 mg/day of LA, or a placebo. However, after two years of treatment, only 65 of the original participants were included in the final analysis. In that subgroup, those who took either 1,200 mg/day or 600 mg/day of LA showed significant improvement in electrophysiological tests of nerve conduction compared to those who took the placebo.

In the longest clinical trial of oral LA therapy, 421 diabetic patients with distal symmetric sensorimotor polyneuropathy took either 600 mg/day of LA or a placebo for four years. No difference between the two groups was seen for the primary endpoint, a composite score that assessed neuropathic impairment of the lower limbs and nerve conduction; however, some measures of neuropathic impairment improved with LA supplementation.

Cardiovascular autonomic neuropathy (CAN)

Another neuropathic complication of diabetes is cardiovascular autonomic neuropathy (CAN), which occurs in as many as 25% of diabetic patients. CAN is characterized by reduced heart rate variability (HRV; variability in the time interval between heartbeats) and is associated with increased risk of mortality in diabetic patients. In a randomized controlled trial of 72 patients with type 2 DM and reduced HRV, oral supplementation with 800 mg/day of LA for four months resulted in significant improvement in 2 out of 4 measures of heart rate variability compared to placebo.

Overall, the available research suggests that treatment with 600 mg/day of intravenous LA for three weeks significantly reduces the symptoms of diabetic peripheral neuropathy. Although the benefit of long-term oral LA supplementation is less clear, there is some evidence to suggest that oral LA may be beneficial in the treatment of diabetic peripheral neuropathy (600-1,800 mg/day) and cardiovascular autonomic neuropathy (800 mg/day).

BIOTIN⁽²⁾

Gluco-Balance™ includes biotin for its role in blood sugar regulation.

Diabetes mellitus

Overt biotin deficiency likely causes abnormalities in glucose regulation in humans. One early human study reported lower serum biotin concentrations in 43 patients with type 2 diabetes mellitus compared to 64 non-diabetic control subjects, as well as an inverse relationship between fasting blood glucose and biotin concentrations. In a small, randomized, placebo-controlled intervention study in 28 patients with type 2 diabetes, daily supplementation with 9 milligrams (mg) of biotin for one month resulted in a mean 45% decrease in fasting blood glucose concentrations.

As a cofactor of carboxylases required for fatty acid synthesis, biotin may increase the utilization of glucose for fat synthesis. Biotin has been found to stimulate glucokinase, a liver enzyme that increases synthesis of glycogen, the storage form of glucose. Biotin also appeared to trigger the secretion of insulin in the pancreas of rats and improve glucose homeostasis.

THIAMIN⁽³⁾

Gluco-Balance™ includes thiamin for its role in blood sugar regulation.

Diabetes mellitus and vascular complications

Low plasma concentrations and high renal clearance of thiamin have been observed in diabetic patients compared to healthy subjects suggesting that individuals with type 1 or type 2 diabetes mellitus are at increased risk for thiamin deficiency. Two thiamin transporters, thiamin transporter-1 (THTR-1) and THTR-2 are involved in thiamin uptake by enterocytes in the small intestine and re-uptake in the proximal tubules of the kidneys. A recent study suggested that hyperglycemia in diabetic patients could affect thiamin re-uptake by decreasing the expression of thiamin transporters in the kidneys. Conversely, thiamin deficiency appears to impair the normal endocrine function of the pancreas and exacerbate hyperglycemia. Early studies showed that insulin synthesis and secretion were altered in the endocrine pancreatic cells of thiamin-deficient rats. In humans, thiamin deficiency caused by recessive mutations in the gene coding for THTR-1 leads to diabetes mellitus in the thiamin-responsive megaloblastic anemia syndrome.

In a randomized, double-blind pilot study, high-dose thiamin supplements (300 mg/day) were given for six weeks to hyperglycemic individuals (either glucose intolerant or newly diagnosed with type 2 diabetes). Thiamin supplementation prevented any further increase in fasting glucose and insulin levels compared with placebo treatment but did not reduce the hyperglycemia. However, one study suggested that thiamin supplementation might improve fasting glucose levels in type 2 diabetics in early stages of the disease (i.e., pre-diabetes or early diabetes).

Chronic hyperglycemia in individuals with diabetes mellitus contributes to the pathogenesis of micro-vascular diseases. Diabetes-related vascular damage can affect the heart (cardiomyopathy), kidneys (nephropathy), retina (retinopathy), and peripheral nervous system (neuropathy). In diabetic subjects, hyperglycemia alters the function of bone marrow-derived endothelial progenitor cells (EPC) that are critical for the growth of blood vessels.

Interestingly, a higher daily intake of thiamin from the diet was correlated with more circulating EPC and with better vascular endothelial health in 88 individuals with type 2 diabetes. An inverse association has also been found between plasma concentrations of thiamin in diabetic patients and the presence of soluble vascular adhesion molecule-1 (sVCAM-1), a marker of vascular dysfunction. Early markers of diabetic nephropathy include the presence of serum albumin in the urine, known as micro-albuminuria. Administration of thiamin or benfotiamine (a thiamin derivative) prevented the development of renal complications in chemically-induced diabetic rats.

A randomized, double-blind study conducted in 40 type 2 diabetic patients with micro-albuminuria found that high-dose thiamin supplementation (300 mg/day) decreased excretion of urinary albumin compared to placebo over a three-month period. Since thiamin treatment has shown promising results in cultured cells and animal models, the effects of thiamin and its derivatives on vascular complications should be examined in diabetic patients.

Summary:

Gluco-Balance™ provides three clinically proven nutrients at the effective dosages shown to help control blood glucose levels in persons with type 2 DM.

R-Alpha Lipoic Acid, Thiamin and Biotin each have demonstrated positive effects in controlling blood sugar, and this unique combination of all three nutrients in one formula promises maximum benefit and without the side effects of prescription medications.

By using DRcaps absorption in substantially increased by delivering the nutrients directly to the small intestine for absorption and would approach absorption comparable to intravenous infusion.

3.4 million People have been diagnosed with diabetes in Canada and probably another million are living with Type 2 Diabetes,” says Dr. Jan Hux, with the Canadian Diabetes Association, “That number has doubled in the last 12 years and there is another diagnosis every 3 minutes.” All of these people can potentially be helped by incorporating Gluco-Balance™ in their daily regime.

References:

1. r-Alpha Lipoic Acid
2. Biotin
3. Thiamin

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DRcaps Improve Absorption

Vitex’s Gluco-Balance™ formula is provided in the new DRcaps.

DRcaps technology enables the active nutrients to pass through the stomach unchanged, and be absorbed in the small intestine. If consumed in conventional capsules, the nutrients can be destroyed by acid in the stomach.

By using DRcaps absorption is substantially increased by delivering the nutrients directly to the small intestine for absorption and would approach absorption comparable to intravenous infusion.

DRcaps have many advantages over traditional enteric coated tablets or capsules. This new technology eliminates the costly enteric coating process which requires the use of solvents and heat which can have destructive effect on the active ingredients in the formula.

DRcaps are resistant to moisture and provide a more precise and consistent dissolution rate compared to traditional enteric coated capsules or tablets.

NOTE: For maximum benefit, take the SOURCE Optimum, SONA based vitamin/mineral/ enzyme formula and VEGAN Omega 3-6-9 to provide the body with optimum levels of other essential nutrients necessary to help maintain long term good health.

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Packaging: Packed in light & oxygen resistant recyclable PETE (Bisphenol A free) bottles.
Gluten Free: Contains no animal substance, artificial preservatives, colours, flavours, starch, sugar, lactose, dairy, salt, yeast or wheat.
DRcaps: Hypromellose polymer, gellan gum(designed to dissolve in the small intestine). Ingredient details can be read here.
DRCaps is a reg. trademark of Capsugel.

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