Orthoplex TMG (Trimethylglycine) 100gm

Orthoplex White TMG (Trimethylglycine) 100gm

10% off RRP at HealthMasters

Orthoplex White TMG (Trimethylglycine) is part of the Orthoplex White Range

Pack Size: 100g oral powder

Orthoplex White TMG Allergen Advice: Gluten Free, Soy Protein Free, Vegan, Dairy Free.

Product Summary

Product Summary: Orthoplex White TMG

Orthoplex White TMG is a powdered formulation of the amino acid derivative Trimethylglycine.

TMG (Trimethylglycine) is a naturally produced amine that can also be synthesised endogenously through the oxidation of choline.

Dose

Dose: Orthoplex White TMG

Adult Dose: One metric 5mL teaspoon contains 4.9g Trimethylglycine (Betaine anhydrous).

Indications

Indications: Orthoplex White TMG

• Reduce elevated homocysteine levels which are associated with cardiovascular disease, osteoporosis, skeletal abnormalities and optic lens dislocation
• Important for fat metbolism in the liver
• Fatty liver
• Alcoholic and nonalcoholic induced fatty liver (steatohepatitis)
• Preventing Methotrexate-induced fatty liver

Technical information

Technical Information: Orthoplex White TMG

Overview

Betaine anhydrous is a chemical that occurs naturally in the body. It is produced by oxidation of choline in the liver and kidneys. Betaine anhydrous is also found in foods such as beets, spinach, whole grains, liver, eggs, and seafood.

Betaine anhydrous is US Food and Drug Administration (FDA)-approved for some types of homocystinuria.

History

Orally, betaine anhydrous is used for homocystinuria caused by cystathionine beta-synthase deficiency, 5,10-methylenetetrahydrofolate reductase deficiency, or cobalamin cofactor metabolism defect. It is also used orally for hyperhomocysteinemia, alcoholic and nonalcoholic steatohepatitis, methotrexate-induced steatohepatitis, liver disease associated with short bowel syndrome, gastroesophageal reflux disease (GERD), fibrocystic breast disease, depression, osteoarthritis, congestive heart failure (CHF), stimulating immune function, improving athletic performance, reducing the risk of colorectal adenoma, and promoting fat loss. Betaine anhydrous is sometimes used to improve development in children with Angelman syndrome or Rett syndrome.

Topically, betaine anhydrous is used as an ingredient in toothpaste or mouthwash to reduce the subjective symptoms of dry mouth. It is also applied along with other ingredients to prevent sunburn.

Adverse Effects

General: Orally, betaine anhydrous can cause vomiting, nausea, GI distress, diarrhea, and body odour. When it is used to treat homocystinuria due to cystathione beta-synthase deficiency, elevated plasma methionine concentrations can occur, which might lead to cerebral edema. Betaine anhydrous might have adverse effects on the plasma lipid profile. Studies have reported a 3% to 4% increase in total and low-density lipoprotein (LDL) cholesterol levels with betaine anhydrous 6 grams daily.

Cardiovascular

Betaine anhydrous might have adverse effects on the plasma lipid profile. Studies have reported a 3% to 4% increase in total and low-density lipoprotein (LDL) cholesterol levels with betaine anhydrous 6 grams/day.

Gastrointestinal

Orally, betaine anhydrous can cause vomiting, nausea, GI distress, and diarrhea.

Neurologic/CNS

When used orally to treat homocystinuria due to cystathione beta-synthase deficiency, elevated plasma methionine concentrations can occur following use of betaine anhydrous, which might lead to cerebral edema.

Other

Orally, betaine anhydrous can cause body odour.

Safety

LIKELY SAFE when used orally and appropriately. Betaine anhydrous is an FDA-approved prescription product.

There is insufficient reliable information regarding the safety of topical betaine.

CHILDREN: LIKELY SAFE when used orally and appropriately. Betaine anhydrous is FDA-approved for use in infants and children.

PREGNANCY AND LACTATION: Insufficient reliable information available; avoid using.

Effectiveness

EFFECTIVE

Homocystinuria. Betaine anhydrous reduces plasma homocysteine levels by 20% to 30% in several types of homocystinuria, including cystathione beta-synthase deficiency, 5,10-methylenetetrahydrofolate reductase deficiency, and cobalamin cofactor metabolism defect. Betaine anhydrous is FDA-approved for this indication.

POSSIBLY EFFECTIVE

Dry mouth. Applying betaine anhydrous topically twice daily as an ingredient of toothpaste at a level of 4% seems to reduce the subjective symptoms of dry mouth when used for 2 weeks. Also, using a specific mouthwash product (Xeros Dentaid) that contains betaine anhydrous, xylitol, and sodium fluoride, each evening for 4 weeks, can improve dry mouth symptoms when compared with baseline, similarly to using a night guard.

Hyperhomocysteinemia. Most clinical research shows that taking betaine anhydrous 3-6 grams daily for up to 12 weeks can modestly decrease plasma homocysteine levels by 5.5% to 15% in people with normal or mildly elevated levels (<25 micromol/L). It is not clear whether any reduction in plasma levels of homocysteine results in a decreased risk for cardiovascular disease.

In patients with renal failure, clinical research shows that taking betaine anhydrous 4 grams daily lowers post-methionine loading plasma homocysteine levels but not fasting levels. However, this dose of betaine anhydrous does not seem to have additive homocysteine-lowering effects in renal failure patients when taken in combination with folate 5 mg daily compared to the effects of folate alone.

POSSIBLY INEFFECTIVE

Angelman syndrome. Clinical research suggests that taking betaine anhydrous (Cystadane, Rare Disease Therapeutics, Inc.) 100-200 mg/kg daily or betaine anhydrous 6-12 grams daily for 12 months, in combination with folate, folic acid derivatives, creatine, and/or vitamin B12, does not prevent seizures or improve cognitive, motor, or language development in children with Angelman syndrome.

INSUFFICIENT RELIABLE EVIDENCE to RATE

Colorectal adenoma. Population research suggests that dietary betaine intake is not significantly associated with colorectal adenoma risk.

Depression. Preliminary clinical research shows that taking a proprietary combination product (DDM Metile, Omeopiacenza) containing S-adenosyl-L-methionine 250 mg and betaine anhydrous 125 mg twice daily for 12 months increases the number of patients with major depression who experience significant symptom improvement compared with amitriptyline 75 mg daily. After 12 months, 63% of patients treated with the combination product showed improvement compared to 3% of patients treated with amitriptyline.

Exercise performance. Some clinical research in men suggests that betaine anhydrous improves some factors associated with resistance training. Taking betaine anhydrous 2.5 grams daily for 2 weeks in combination with resistance training improves body composition, bench press work capacity, and arm size compared to placebo in men with strength-training experience. Other evidence suggests that taking betaine anhydrous 2.5 grams daily for 2 weeks improves total repetitions and volume load during bench press exercises compared to pretreatment in resistance-trained men. Also, taking betaine anhydrous 2.5 grams daily for 15 days reduces fatigue following chest press exercises compared to placebo in recreationally active men, although peak force during exercises or soreness after the exercises is not improved with betaine supplementation. However, some contradictory evidence suggests that taking betaine anhydrous does not improve athletic performance. Taking betaine anhydrous 2 grams daily for 10 days without exercise training does not improve muscle power or strength compared to placebo in untrained men. Also, drinking a one liter beverage containing betaine anhydrous 5 grams after becoming dehydrated does not seem to improve long-distance running or sprinting after rehydration compared to placebo in trained male runners.

Research in women is limited. One preliminary clinical study in a small group of active but untrained young women shows that taking betaine anhydrous (BetaPower, Finnfeeds) 2.5 grams daily for 8 weeks in combination with a structured resistance training program reduces body fat percentage and body fat mass, but does not improve muscle strength, when compared with placebo.

Overall, research suggests that the benefits of betaine anhydrous are most associated with strength training in trained men. The effects in untrained men or in women, or on exercise following exercise-induced rehydration, requires further research.

Gastroesophageal reflux disease (GERD). Preliminary clinical research shows that taking a combination of betaine anhydrous 100 mg, melatonin 6 mg, L-tryptophan 200 mg, vitamin B6 25 mg, folic acid 10 mg, vitamin B12 50 mcg, and methionine 100 mg daily for 40 days reduces symptoms of GERD in more patients compared to omeprazole 20 mg daily. All patients who took this combination supplement showed symptom improvement compared to only 66% of patients taking omeprazole.

Hepatitis C. Preliminary clinical research suggests that taking pegylated interferon alpha and ribavirin in combination with betaine anhydrous (Cystadane, Rare Disease Therapeutics, Inc.) and S-adenosyl-L-methionine daily for 12 months can induce early virological response in approximately 60% of hepatitis C patients who were previously unresponsive to treatment with pegylated interferon alpha and ribavirin. However, sustained virological response occurs in only 10% of these patients.

Nonalcoholic steatohepatitis (NASH). Preliminary clinical research suggests that betaine anhydrous might be useful for nonalcoholic steatohepatitis. Use of 10 grams twice daily for 12 months can normalize liver enzymes and improve the degree of steatosis, inflammation, and fibrosis.

Sunburn. Preliminary clinical research suggests that applying a specific cream (Physiogel AI), which contains Npalmitoylethanolamine 0.3%, N-acetylethanolamine 0.21%, betaine anhydrous 0.36%, and sarcosine 0.24%, daily for one month prior to ultraviolet (UV) light exposure can reduce UV-induced redness. However, application of this cream only once 20 minutes prior to UV exposure does not have any effect.

Rett syndrome. Preliminary clinical research suggests that taking a combination of folate 15 mg and betaine anhydrous 6-12 grams daily for 12 months does not improve motor function, growth, or development compared with placebo in girls with Rett syndrome, although head circumference growth is reduced.

Weightloss. In a small study of obese adults on a reduced-calorie diet, addition of betaine anhydrous 3 grams twice daily for 12 weeks did not produce any extra decrease in body weight, fat mass, or resting energy expenditure compared with placebo.

Depression: A proprietary combination product (DDM Metile, Omeopiacenza, Piacenza, Italy) containing S-adenosyl-Lmethionine 250 mg and betaine anhydrous 125 mg twice daily for 12 months has been used.

Exercise performance: Betaine anhydrous 2.5 grams daily for 14-15 days has been used.

Gastroesophageal reflux disease (GERD): A combination of betaine anhydrous 100 mg, melatonin 6 mg, L-tryptophan 200 mg, vitamin B6 25 mg, folic acid 10 mg, vitamin B12 50 mcg, and methionine 100 mg daily for 40 days has been used.

Hepatitis C: A specific betaine anhydrous product (Cystadane powder, Orphan Europe) 3 grams twice daily and Sadenosyl-L-methionine (Gumbaral, AWD.pharma GmbH & Co.) 400 mg three times daily for one week have been used as a pre-treatment, followed by a combination of S-adenosyl-L-methionine and betaine anhydrous along with oral ribavirin (Rebetol, Essex Chemie AG) 800-1200 mg daily plus subcutaneous pegIFNa2b (PegIntron, Essex Chemie AG, Luzern, Switzerland) 1.5 mg/kg bodyweight once weekly for 12-48 weeks, has been used).

Homocystinuria: A maintenance dose of 3 grams betaine anhydrous is typically taken twice daily. Some patients may require doses up to 20 grams per day. Dissolve the powder in water, juice, milk, or formula, or mix with food immediately before administration.

Hyperhomocysteinemia: Betaine anhydrous 3-6 grams daily for 1-12 weeks has been used.

Nonalcoholic steatohepatitis (NASH): Betaine anhydrous 10 grams twice daily for 12 months has been used.

Topical:

Dry mouth: Betaine anhydrous 4% toothpaste twice daily for 2 weeks has been used. A specific mouthwash product (Xeros Dentaid) containing betaine anhydrous, xylitol, and sodium fluoride, applied as a rinse each evening for 4 weeks, has been used.

Sunburn: A specific cream (Physiogel AI), which contains N-palmitoylethanolamine 0.3%, N-acetylethanolamine 0.21%, betaine anhydrous 0.36%, and sarcosine 0.24%, applied daily for one month, has been used.

Children

Oral:

Homocystinuria: A maintenance dose of 3 grams betaine anhydrous is typically taken twice daily. Dose titration is preferable in children. For children under three years-old, the starting dose is 100 mg/kg daily, increased at weekly intervals by increments of 50 mg/kg. Doses up to 20 grams daily might be needed. Dissolve the powder in water, juice, milk, or formula, or mix with food immediately before administration.

Standardization & Formulation

Betaine anhydrous is used orally and topically in clinical trials. Topical betaine anhydrous products have included toothpaste, mouthwash (Xeros Dentaid), and cream (Physiogel AI). The most studied oral betaine product is an FDA-approved prescription product (Cystadane).

Interactions with Drugs

None known.

Interactions with Supplements

None known.

Interactions with Conditions

HYPERCHOLESTEROLEMIA

Clinical research suggests that betaine anhydrous can increase levels of total and low-density lipoprotein (LDL) cholesterol in healthy individuals, obese patients, and patients with chronic renal failure. Theoretically, betaine might increase levels of total and LDL-cholesterol in individuals with cholesterol levels that are already too high. Tell hypercholesterolemic patients to use betaine anhydrous cautiously.

Interactions with Lab Tests

None known.

Overdose

There is insufficient reliable information available about the toxicology of betaine anhydrous.

Pharmacokinetics

Absorption: Betaine anhydrous is absorbed rapidly when taken orally with 50% absorption within 0.4 hours. Maximum concentrations were reached in plasma in approximately one hour. Supplementation with betaine anhydrous 6 grams daily can increase plasma betaine 10-fold over 12 weeks.

Distribution: Betaine anhydrous has a high volume of distribution due to extensive distribution to tissues, including the kidneys and liver. When consumed orally, 50% of betaine anhydrous is distributed within approximately 0.5-1.75 hours, depending on dosing schedule.

Metabolism: Betaine anhydrous is used in the methionine/homocysteine cycle, where it acts as a methyl donor. One route of homocysteine metabolism is by methylation to form methionine, using a methyl group from methylcobalamin or from betaine anhydrous. Methionine is then converted to S-adenosylmethione. Dimethyl glycine is the byproduct of betaine metabolism in the homocysteine re-methylation pathway, and concentrations of dimethyl glycine increase in healthy subjects after betaine supplementation.

Excretion: The mean elimination half-life of betaine anhydrous is 14 hours after a single dose, and 41 hours after dosing for 5 days. Time to elimination ranges from 13 hours to 25.9 hours for doses between 1-6g, and did not increase with increasing doses of betaine. Only 4% of the ingested betaine anhydrous is excreted as betaine anhydrous in urine; therefore the main elimination is through metabolism to dimethylglycine.

Mechanism of Action

General: Betaine anhydrous occurs naturally in the body. It is produced by oxidation of choline in the liver and kidneys. It is a methyl derivative of the amino acid glycine. Betaine anhydrous is found in foods such as beets, spinach, whole grains, liver, eggs, and seafood. Levels in plant food sources depend on growing conditions. For example, spinach grown in saline soil accumulates betaine anhydrous. Levels are reduced by cooking, especially boiling. Dietary intake has been estimated at 100-400 mg/day or 1 gram/day on average, and up to 2.5 grams/day with diets rich in whole wheat and seafood.

Anticancer effects: The risk of colorectal adenoma has been linked to low dietary intake of nutrients such as folate and methionine, which are involved in methylation pathways. Therefore, it has been suggested that betaine might reduce the risk of colorectal adenoma. However, this has not been shown in humans.

Exercise performance effects: Betaine can act as a methyl donor in the formation of creatine in the body, leading to the suggestion that it may improve athletic performance, and increase exercise tolerance and cardiac function in people with heart failure. Betaine anhydrous might also enhance muscle oxygen consumption or extraction.

Homocysteine lowering effects: Betaine anhydrous is used in the methionine/homocysteine cycle, where it acts as a methyl donor. One route of homocysteine metabolism is by methylation to form methionine, using a methyl group from methylcobalamin or from betaine anhydrous. Methionine is then converted to S-adenosylmethione (SAMe). In people with homocystinuria due to various inborn errors of metabolism, total plasma homocysteine concentrations are very high, >50 micromol/L, compared to normal levels of 5 to 15 micromol/L. These elevated homocysteine levels are associated with cardiovascular disease, osteoporosis, skeletal abnormalities and optic lens dislocation. When taken orally, betaine anhydrous can significantly reduce these elevated homocysteine levels. A reduction in plasma homocysteine is seen within a week, and steady state is reached within a month.

It has been suggested that the betaine content of wine may contribute to the lower incidence of cardiovascular disease in countries with a high wine consumption such as France, but it is not known whether the levels present, approximately 3 mg per glass, have any significant effect.

Following bariatric surgery, plasma levels of homocysteine levels increase in obese patients. After ruling out other potentialmechanisms, it has been suggested that this is associated with a decrease in plasma levels of betaine following surgery. Therefore, betaine anhydrous supplementation might prevent the increase in homocysteine levels in these patients. However, this has not yet been shown in clinical research.

Liver effects: The role of betaine anhydrous as a methyl donor in the formation of methionine and S-adenosyl-methionine may be important for fat metabolism in the liver. S-adenosyl-methionine is involved in the methylation of phosphatidylethanolamine to form phosphatidylcholine, which enhances secretion of very low density lipoprotein (VLDL) to transport fat out of the liver. Betaine anhydrous can therefore act as a lipotrope, preventing or reducing accumulation of fat in the liver, such as occurs in nonalcoholic steatohepatitis and other forms of fatty liver disease. S-adenosyl-methionine synthesis is reduced by chronic ethanol intake, due to inhibition of methionine synthase. Preliminary evidence from animal studies suggests that betaine anhydrous might prevent and reverse ethanol-induced steatohepatitis. Methotrexate also reduces S-adenosyl-methionine synthesis. It prevents conversion of dihydrofolate to 5- methyltetrahydrofolate which is used in the formation of methylcobalamin, and hence in the methylation of homocysteine to methionine and S-adenosyl-methionine. Because betaine anhydrous provides an alternative pathway for methylation of homocysteine and increases S-adenosyl-methionine synthesis, it might prevent methotrexate-induced hepatic steatosis. Similarly, it is hypothesized that betaine anhydrous might reduce fatty liver damage associated with high doses of niacin. Metabolism of niacin involves methylation by S-adenosyl-methionine; hence high doses may deplete S-adenosyl-methionine levels, decrease phosphatidylcholine synthesis, and cause fatty liver changes.

Mouth moisturizing effects: Various products containing betaine have been shown to improve the feeling of dry mouth. Clinical research suggests that mouthwash containing betaine and other products improves saliva flow in the mouth.

Osmolytic effects: In the body, betaine anhydrous is an osmolyte, which maintains normal cell volume and protects intracellular enzymes under conditions of osmotic stress, without interfering with cellular function. By this mechanism it protects kidney cells from high concentrations of electrolytes and urea.

Weightloss effects: Reports that betaine anhydrous improves liver fat metabolism and reduces adipose tissue in animals led to suggestions that it might decrease fat mass in humans. Although betaine anhydrous has been found to reduce adipose tissue in pigs, this has not yet been shown in humans.

Ingredients

Ingredients: Orthoplex White TMG

Allergen Advice

Allergen Advice: Orthoplex White TMG

Gluten Free, Soy Protein Free, Vegan, Dairy Free.

Storage

Storage: Orthoplex White TMG

Store below 30C in a cool, dry place, away from direct sunlight.

Warning

Warning: Orthoplex White TMG

Not all cautions and contraindications are listed. For full details, references or more information contact HealthMasters in Australia by email: reception@healthmasters.com.au.

Always read the label. Use only as directed. If symptoms persist consult your healthcare professional.

Pregnancy & Lactation

Pregnancy & Lactation: Orthoplex White TMG

Not suitable

Companion Products

Companion Products: Orthoplex White TMG

• Orthoplex N-acetylcysteine
• Orthoplex SAMe 200mg
• Orthoplex BioEnhanced Methyl-B

Orthoplex White

Orthoplex White

Orthoplex White Label is a range for clinical practitioners, developed for the increasing complexity of ailments presenting in clinic. To purchase products in the Orthoplex White Label range, patients must have a consultation with a clinical practitioner. Stockists of this range are bound by a contractual set of selling standards, ensuring the products are used correctly, and contributing to the robust integrity of the industry.

'I am impressed with the quality and effectiveness of Orthoplex White Label products. I have prescribed Orthoplex White Label products to my patients for over 30 years. Orthoplex White Label products have assisted me in successfully helping many 1000's of patients to better health.'

HealthMasters Naturopath Kevin Tresize ND

The Orthoplex White Label range was developed by nutritional biochemist Henry Osieki. Henry is an award-winning biochemist who, after years in clinic, developed the Orthoplex label Range of Naturopathic Medicines. The Orthoplex White Label range is known for being the first to market with new formulations, incorporating the latest in clinical research.

Orthoplex White Label formulations have always focused on providing the correct dosage for specific biochemical pathways, rather than just delivering the largest dose possible.

Orthoplex White Label is a practitioner range of naturopathic products and should be taken according to the recommendation of a qualified practitioner.