Select a page for this section using the sidebar.
Alpha Lipoic Acid
*Found in Advanced Nerve Health Supplement
In clinical trials, 600 mg alpha-lipoic acid has been shown to improve neuropathic deficits
Alpha-lipoic acid in diabetic neuropathy works by reducing oxidative stress along with improving nerve blood flow, nerve conduction velocity, and several other measures of nerve function.
The SYDNEY 2 trial was a multicenter, randomized, double-blind, placebo-controlled trial, consisting of 181 diabetic patients. Patients received once-daily oral doses of alpha lipoic acid at 600 mg, 1,200 mg, and 1,800 mg or placebo for 5 weeks. After 5 weeks, patients treated with alpha lipoic acid at 600 mg/day or more showed improved neuropathic symptoms and deficits (described as burning, pain, numbness, and prickling of the feet and leg). However, there was a dose-dependent increase in side effects of nausea, vomiting, and vertigo. An oral dose of 600 mg once daily appears to provide the best benefit with least side effects.
Additional clinical studies supporting its use in neuropathy:
- neuropathy study #1
- neuropathy study #2
- neuropathy study #3
- neuropathy study #4
- neuropathy study #5
- neuropathy study #6
- neuropathy study #7
Most evidence suggests that alpha-lipoic acid, at doses of at least 300mg/day orally for 4-8 weeks improves insulin sensitivity, fasting blood glucose levels, and glucose clearance in patients with type 2 diabetes. Results showed that fasting blood glucose and HbA1c trended to decrease in a dose-dependent manner. (4,5,6)
Findings of a review of 12 clinical trials showed that alpha-lipoic acid supplementation reduced body weight by -0.69 kg and BMI by -0.38 kg/m2 compared to the placebo group. It was suggested that safe dosage for alpha-lipoic acid is up to 1200 mg/day.
In another comprehensive systematic literature review of 10 articles on randomized double blind placebo controlled studies with alpha-lipoic acid, treatment showed small, yet significant short-term weight loss compared with placebo. Alpha-lipoic acid treatment demonstrated 1.27 kg greater mean weight loss compared with the placebo group.
*Found in EARLY DEFENSE and MULTI-COMPLETE supplements
This study has shown that banaba at the dose of 50-100 mg once daily was well tolerated, improved insulin sensitivity and preserved beta cell pancreatic function in subjects with impaired glucose tolerance (i.e. prediabetes).
A clinical study shows that patients with type 2 diabetes who took a specific banaba extract standardized to 1% corosolic acid (as found in our products), at doses of 32 and 48mg/day for 2 weeks showed a 20% decrease in blood sugar levels than patients taking placebo.
Another clinical study shows that taking a specific product containing a combination of extracts of banaba leaf and cinnamon inner bark 100 mg/day for 12 weeks reduces HbA1c by approximately 0.65%. This was in patients who had type 2 diabetes not controlled on Metformin and other oral medications. Additionally, iinsulin sensitivity, lipid profile and adiponectin level were improved considerably.
*Found in Mealtime Sugar-Blocker Supplement
Berberine is a compound found in plants such as barberry, tree turmeric, Oregon grape, goldenseal, yellowroot and Chinese goldthread, among others – used in ancient Chinese medicine for thousands of years. Berberine works through a variety of mechanisms to lower blood glucose in patients with diabetes. It is thought to increase insulin sensitivity and stimulate liver cells, muscle cells and fat cells to take up glucose through a process that does not depend upon insulin (which in turn helps reduce fatty liver, blood glucose, and lipids). Berberine also acts on α-glucosidase, an intestinal enzyme that breaks down carbohydrates into simple sugars. Blocking this enzyme means less carbohydrates from food are absorbed leading to lower blood sugar levels after meals. Only berberine at doses of 500 mg three times daily have been shown to be effective for blood sugar lowering. Higher doses could lead to berberine toxicity and lower doses may not be effective.
Two separate clinical trials show that taking berberine 500 mg twice daily for 3 months can reduce hemoglobin A1c, fasting blood sugars, and after meal blood sugars in subjects with type 2 diabetes and dyslipidemia (abnormal cholesterol) compared to placebo. Mild to moderate constipation was observed in five participants in the berberine group. (9)
One of the studies from 2008 reported that it was as effective as the prescription medication Metformin. This study included 36 adult patients who were either randomized to Berberine or Metformin 500 mg three times daily. Patients treated with Berberine saw significant decreases in A1C from 9.5% to 7.5% as well as lower fasting and after meal blood sugars. (10)
Another study found it was as effective as prescription medication rosiglitazone (also known as Avandia®, similar to today’s drug pioglitazone/Actos®).
Additionally, an analysis of 27 randomized controlled clinical trials including 2569 patients showed that using berberine in combination with lifestyle interventions, with or without prescription medications, lowers blood sugars and A1C by 0.58-0.71%. Notably, no serious adverse reaction were reported in the 27 experiments.
Early clinical evidence suggests that taking berberine 600 mg twice daily for 12 weeks decreases cholesterol and markers of liver damage, including AST and ALT in patients with non-alcoholic fatty liver disease and type 2 diabetes.
A clinical study demonstrated that taking berberine 500 mg three times daily for 12 weeks reduces weight in obese patients by approximately 5 lbs compared to pretreatment.
*Found in MULTI-Complete supplement
An analysis of several clinical trials shows that taking cassia cinnamon at doses ranging from 120 mg to 6 grams daily for 4-18 weeks significantly reduces fasting blood glucose by an average of 24.59 mg/dL, total cholesterol by 15.60 mg/dL, LDL by 9.42 mg/dL, triglycerides by 29.59 mg/dL and increases high-density lipoprotein (HDL) by 1.66 mg/dL in patients with type 2 diabetes.
Different dosage forms seem to have different effects. Capsulized dosage forms of cassia cinnamon significantly reduced fasting blood glucose and HbA1c; however, powder forms had no significant effect on either of these outcomes
There is insufficient evidence linking cinnamon to benefit in pre-diabetes – therefore, at this time it is exclusively/only recommending for use in patients who already have established diagnosis of type 2 diabetes
*Found in MULTI-Complete Supplement
Chromium is an essential mineral required for carbohydrate and lipid metabolism.
A four-month controlled, single blind, randomized trial was performed with 71 patients with poorly controlled hemoglobin A1c (defined as > 7%). Patents were given 600 mcg/day of chromium picolinate. It was found that the chromium supplementation significantly reduced fasting glucose concentration (-31.0mg/dL supplemented group and -14.0mg/dL control group) and after-meal glucose concentration (-37.0mg/dL in the supplemented group and -11.5 mg/dL in the control group). Post-treatment HbA1c values in supplemented patients were significantly lower than those of control patients. HbA1c lowering in the supplemented group was -1.90%, and in the control group was only -1.00. No serious side effects were reported.
Analyses of 10-18 clinical studies show that taking chromium can decrease HbA1C by up to 0.6% and fasting blood glucose by up to 18 mg/dL, as well as increase insulin sensitivity in people with type 2 diabetes.
Another study of 37 patients with type 2 diabetes who were taking a sulfonylurea (glipizide 5mg/day) were given chromium picolinate 1000 mcg/day. The study showed that adding chromium supplementation in these patients significantly improves insulin sensitivity, glucose control and decreased body weight gain and fat accumulation compared with the placebo group.
Some clinical research shows that taking elemental chromium 15-200 mcg daily for 6-12 weeks decreases low-density lipoprotein (LDL) cholesterol and total cholesterol.
*Found in EARLY DEFENSE supplement
Curcumin is a naturally-occurring chemical polyphenol compound found in the spice turmeric.
Curcumin has been documented in publications as early as 1972 to be associated with diabetes prevention.
In a study of 240 patients with prediabetes treated for 9 months with curcumin, 16.4% of subjects in the placebo group were diagnosed with type 2 diabetes, whereas NONE were diagnosed with type 2 diabetes in the curcumin-treated group. In addition, the curcumin-treated group showed a better overall function of pancreatic beta-cells and lower levels of insulin resistance. Other benefits seen were increased levels of the anti-inflammatory biochemical adiponectin and a reduction in average body weight and waist circumference. None of the curcumin-treated patients reported worsening kidney or liver function or hypoglycemia (low blood sugars). The doses of curcumin used were 250 mg of total curcuminoids content per capsule (21)
Figure: Reduction in A1C observed in patients taking curcumin.
Curcumin’s effects on liver have been studied in two separate randomized placebo-controlled trials. In one trial, compared with placebo, curcumin was associated with a significant reduction in liver fat content (78.9% improvement in the curcumin vs 27.5% improvement in the placebo group). The second trial showed liver fat was significantly improved in 75.0% of subjects in the curcumin group, while the rate of improvement in the control group was only 4.7%. These outcomes were reported over a period of taking curcumin for 8 weeks at 500 mg per dose.
The studies also reported significant reductions in body mass index (BMI) and cholesterol, liver enzymes (AST/ALT) blood sugar, and A1C in patients taking Curcumin. Curcumin was safe and well tolerated during the course of trial. (23, 24)
One analysis of data from 7 clinical studies shows that taking turmeric, or curcumin, moderately reduces LDL cholesterol and triglyceride levels. Another analysis of data from 20 clinical studies shows that taking turmeric significantly reduces triglycerides and improves HDL cholesterol compared to placebo. Ultimately, turmeric and curcumin may protect patients at risk of cardiovascular disease through improving serum lipid/cholesterol levels. Turmeric and curcumin appeared safe, and no serious adverse events were reported.
*Found in MEALTIME SUGAR- BLOCKER Supplements
Gymnema sylvestre, a shrub native to the tropical forests of India, Africa and Australia, has been used in ancient Indian medicinal practice for thousands of years. Its name means “destroyer of sugar” in Hindi. Gymnemic acids in Gymnema sylvestre can block the sugar receptors on the tongue, decreasing the ability to taste sweetness, leading to reduced sugar cravings. Additionally, research shows it can slow the absorption of glucose from the intestines and may help repair and regenerate pancreatic beta cells (the insulin producing cells in the pancreas).
A study in 60 moderately-obese people taking a Gymnema extract found a 5–6% decrease in body weight, as well as reduced food intake likely due to appetite suppression.
In a newly published trial from 2017, Gymnema has demonstrated benefits in people with prediabetes. There were 24 patients participating, aged 30-60 years old, obese and with signs of prediabetes and metabolic syndrome. About half the patients took 300 mg Gymnema capsules twice daily and the other half took placebo for a total of 90 days.
The Gymnema supplement group lost 3.4 lbs on average while the placebo group gained 3.3 lbs (a 6.7 lb difference). Patients also had an improved BMI and smaller waist circumference at the end of the trial. Additionally, LDL cholesterol decreased by 9 points. No changes were observed in insulin sensitivity or insulin production.
In one clinical trial, 22 people with type 2 diabetes took 400 mg of Gymnema sylvestre extract (GS4®) daily in addition to their oral diabetes prescription medications. People taking the Gymnema supplement experienced significant reductions in blood sugar and hemoglobin A1C over 18 months. Additionally, the participants were able to reduce their drug dosages, and 5 of the study subjects were even able to stop their prescription medications and maintain normal blood sugar levels with the Gymnema supplement alone.
Another study with 65 patients showed that after 90 days of taking a Gymnema sylvestre supplement (Beta Fast GXR®), mean fasting sugars were reduced by 11%, after meal sugars reduced by 13%, and HbA1C reduced by 0.6%. In patients who had higher starting levels of HbA1C (defined as greater than 10%), they saw more profound results including a 1.1% decrease in HbA1C. Remarkably, 16% of patients had a decrease in prescription medicine intake.
*Found in Advanced Nerve Health Supplement
CHRONIC VENOUS INSUFFICIENCY
In a systematic literature search, 13 randomized clinical control trials and 3 observational studies totaling over 10,000 patients were identified. These studies have shown that taking horse chestnut seed extract orally can reduce some symptoms of chronic venous insufficiency, such as varicose veins, pain, tiredness, tension, itching, edema, and swelling in the legs. In these studies, horse chestnut seed extract seems to be comparable in efficacy to compression stocking. Notably, an advantage with an oral supplement is that it is easier to take an oral pill versus wear compression stockings. Horse chestnut seed extract appears to be safe and well tolerated.
- Horse Chestnut Study #1
- Horse Chestnut Study #2
- Horse Chestnut Study #3
- Horse Chestnut Study #4
- Horse Chestnut Study #5
- Horse Chestnut Study #6
Found in EARLY DEFENSE and MULTI-COMPLETE Supplements
Higher dietary magnesium intake is associated with lower fasting insulin concentrations - which generally implies greater insulin sensitivity. Other research suggest that a 100 mg/day increase in dietary magnesium intake is associated with a 15% risk reduction for developing type 2 diabetes.
- Magnesium Study #1
- Magnesium Study #2
- Magnesium Study #3
- Magnesium Study #4
- Magnesium Study #5
- Magnesium Study #6
In people already diagnosed with type 2 diabetes, hypomagnesemia (or low Magnesium levels in the blood) occurs in up to 38% of patients. Hypomagnesemia is more common in people with poorly controlled diabetes and is associated with a more rapid decline in kidney function in patients with type 2 diabetes. Some research suggests magnesium supplements can decrease fasting blood glucose and improve insulin sensitivity.
- Blood Glucose and Insulin Sensitivity Study #1
- Blood Glucose and Insulin Sensitivity Study #2
- Blood Glucose and Insulin Sensitivity Study #3
- Blood Glucose and Insulin Sensitivity Study #4
- Blood Glucose and Insulin Sensitivity Study #5
Milk Thistle Extract/Silymarin
*Found in MULTI-COMPLETE
Clinical research shows that taking milk thistle extract of silymarin 140 mg three times daily for 45 days reduces fasting blood glucose by 11%, reduces insulin levels/needs by 14%, and improves insulin resistance by 26% in patients with type 2 diabetes. Patients who did not take the supplement (placebo group) experienced worsening values - an 8% increase in blood glucose, a 26% increase in insulin, and a 37% increase in insulin resistance. There were also improvements in high-density lipoprotein (HDL) cholesterol levels.
Other early clinical research shows that taking milk thistle extract of silymarin 200 mg one or three times daily for 4 months, in combination with medication(s), decreases fasting blood glucose by 23-43 mg/dL and hemoglobin A1c (HbA1c) by 1% to 1.5% compared to baseline in patients with type 2 diabetes, on top of prescription therapy.
A meta-analysis of 8 clinical trials shows that taking silymarin significantly reduces liver enzymes aspartate aminotransferase (AST) by 6.6 IU/L and alanine aminotransferase (ALT) by 9.2 IU/L compared to control in patients with non-alcoholic fatty liver disease.
Early clinical research shows that taking a milk thistle extract of silymarin 140 mg orally three times daily for 3 months, in combination with standard treatment, decreases the urine albumin to creatinine ratio (i.e. protein in the urine, a marker of kidney function) compared to placebo in type 2 diabetic patients with diabetic kidney disease.
*Found in MULTI-COMPLETE and Advanced Nerve Health Supplements
VITAMIN B12 DEFICIENCY
Replacement of Vitamin B12 deficiency can be in the form of an intramuscular injection or oral supplements in recommended doses of 1000-2000 mcg/day.
Metformin Associated Vitamin B12 Deficiency
Metformin is one of the oldest and most commonly prescribed blood sugar-lowering drugs used in the treatment of type 2 diabetes. Approximately 120 million diabetes patients worldwide are treated with this drug. Long-term use of metformin can lead to vitamin B12 (cobalamin) deficiency. Vitamin B12 deficiency associated with metformin use is thought to occur due to vitamin B12 malabsorption. Chronic metformin use results in vitamin B12 deficiency in an estimated 30% of patients.
Cyanocobalamin is a synthetic form of vitamin B12 that is not found in nature. Unlike cyanocobalamin, methylcobalamin is a naturally occurring form of vitamin B12 that can be obtained through supplements, as well as food sources like fish, meat, eggs and milk. Methylcobalamin is the highly absorb-able and readily active form of Vitamin B12 used in our supplements.
In this clinical study, taking oral or intravenous methylcobalamin for up to 4 months seems to improve pain and autonomic symptoms in patients with diabetic peripheral neuropathy.
Another study of 108 patients taking mecobalamin (Vitamin B12) intramuscularly for 4 weeks then 500 mcg orally three times daily for 8 weeks, shows that pain and numbness of limbs were improved by 73% and 75% in the mecobalamin group, which were much higher than those in the controls (36% and 45% respectively).
In a different study, 42 patients who had long-standing diabetes (mean duration of 12 years) with symptoms of neuropathy were divided into two groups of 21 patients. Each group was given either methylcobalamin or placebo. The 21 patients receiving methylcobalamin showed significant improvement in nerve pain and cramps. No adverse effects were observed. The mechanism of action is due partly to improvement in motor and sensory function, possibly by promoting myelin and axonal phospholipid synthesis.
- Nerve Pain and Neuropathy Study #1
- Nerve Pain and Neuropathy Study #2
- Nerve Pain and Neuropathy Study #3
- Nerve Pain and Neuropathy Study #4
- Nerve Pain and Neuropathy Study #5
*Found in EARLY DEFENSE & Advanced Nerve Health Supplement
In a study of 903 adult patients with prediabetes, using vitamin D supplementation to increase plasma vitamin D (25(OH)D) levels reduced the risk of developing diabetes by approximately 70-81%. The prevention of diabetes development is thought to be via a mechanism of pancreatic beta-cell preservation.
Figure: Shows the correlation of reduced diabetes incidence/development with increasing plasma vitamin D levels.
Other research shows that pancreatic beta cells have Vitamin D receptors and, when activated, they can stimulate the pancreas to produce insulin. An increasing amount of evidence suggests that vitamin D also affects these insulin producing cells directly thereby rendering them more resistant to the types of cellular stress encountered during diabetes.
Low vitamin D levels have been linked to numerous health conditions including diabetic peripheral neuropathy. In a study of 59 white European patients, it was found that vitamin D levels were significantly lower in the participants with painful neuropathy. Researchers additionally found that people with the highest pain scores had the lowest serum vitamin D levels – suggesting that replacement may help alleviate the pain. Vitamin D’s role in pain may be credited to its action in the small nerve fibers of the dorsal root ganglia.