Biotone EFA

Rationale & Viability of revised Biotone EFA Formulation

Biotone EFA has many therapeutic indications as supported by various forms of research as noted below. Seroyal is continuously researching each ingredient in each one of our formulations against the most recent scientific evidence. As we propose these findings to our expert committee we believe it is sometimes necessary after laborious analysis of the research and our client’s expectations, to optimize our formulations to remain as a leader in the natural pharmaceutical industry.

Changes on the Biotone EFA label:

• The phytosterol amount has been increased from 16 mg/capsule to 112 mg/capsule based on recent evidence of the benefits of phytosterols on cardiovascular health and cholesterol reduction.
• Along with octacosanol, we have added hexacosanol, tetracosanol, triacontanol and dotriacontanol. All of these components are included under policosanol, which has been found to have positive effects on cardiovascular health and cholesterol reduction.

Background
Cardiovascular disease (CVD), including stroke, coronary occlusion, ischemic heart disease (IHD), atherosclerosis heart disease, vascular and coronary thrombosis, is the leading cause of death in most western societies. The factors most consistently associated with an increase in the incidence of CVD include hypertension, hypercholesterolemia, and cigarette smoking. Other modifiable risk factors include obesity, lack of exercise, hypertriglyceridemia and low high-density lipoprotein-cholesterol (HDL-C) levels (Patch et al, 2006).

The clinical manifestations of CVD are chronic arterial obstructions or acute arterial occlusions in various territories, which ultimately lead to the condition where there is an inadequate supply of blood to the heart muscle, brain or visceral limbs leading to ischemia in severe cases, myocardial infarction (Patch et al, 2006).

High blood cholesterol level (especially LDL cholesterol) is a risk factor for coronary heart disease (CHD). Oxidation of excess LDL cholesterol leads to arterial wall plaque build up, which then restricts blood flow and increased risk of coronary heart disease and stroke.

Biotone EFA is a unique combination of rice bran, soybean and wheat germ oils specifically formulated to support and regulate hormonal function. Rice bran and wheat germ oils are high in octacosanol, fatty acids, phytosterols, and in ketosteroids, anabolic growth agents, and lipotropic factors. Octacosanol, found in wheat and in rice oil fractions, improves heart functions, increases vitality and endurance, prevents muscle spasms, and duplicates the biological effects of sex hormones and ketosteroids without the side-effects associated with hormone therapy.

How are Essential Fatty Acids (EFAs) broken down in the body? Does
it require much work from the liver? 

EFAs are broken down in the gut (hydrolyzed) and the individual fatty acids are absorbed by the enterocytes lining the GI tract. The enterocytes assemble the fatty acids and glycerol into triglycerides.The triglycerides and other fat soluble nutrients are collected and assembled into chylomicrons, which are absorbed by the lacteals (lymphatic vessels of the small intestines). The chylomicrons flow with the lymph into the blood and reaches every tissue in the body. In the tissues the triglycerides are absorbed in a similar way as triglycerides are absorbed by the enterocytes. In the tissues the fatty acids can be metabolized into for example local hormones.

The hydrolization process in the gut requires lipase secreted by the pancreas and bile synthesized in the liver and secreted from the gallbladder.

Supplement Facts
Serving Size 2 Capsules
Servings per Container 50
Each Two Capsules Contain

• Calories 5
• Vitamin E (d-alpha tocopherol) 0.30 IU
• Linoleic Acid
  (from Carthamus tinctorius/ 348 mg Linum usitatissimum seed oil)
• Alpha-Linolenic Acid (from Linum usitatissimum seed oil) 36 mg
• Phytosterols (from Glycine max bean) 224 mg
• Soy (Glycine max) Lecithin 40 mg
• Policosanol (from Apis mellifera wax) 5 mg
• Delta-Tocopherol 1.4 mg
• Gamma-Tocopherol 66 mcg

Other ingredients: Gelatin, glycerin, purified water, yellow beeswax

Recommended Adult Dose: Take two capsules two times daily, or as recommended by your health care practitioner.
Guaranteed to contain no added wheat, starch, yeast, gluten, corn, sodium, sugar, artificial coloring or flavoring, preservatives or dairy products.
 

Quality Assurance Tamper-resistant package. Do not use if outer seal is missing or broken. Store in a cool, dry place.

Biotone EFA is indicated for hormonal imbalances, including premenstrual and menopausal disorders; and for maintaining skin elasticity, energy levels and a strong immune system during periods of stress. Biotone EFA can be taken as an organic alternative to steroids for those athletes and individuals who want to increase performance, lean muscle mass and strength, without the side-effects associated with synthetic steroids.

Contraindications
None known.

Available as
100 Capsules    400

Research & Scientific Rationale
Plant sterols are plant compounds with similar chemical structure and biological functions as cholesterol. It has been reported that phytosterols esters reduce cholesterol absorption and lower serum cholesterol concentration; sterols are an essential component of cell membranes, and both animals and plants produce them. Sterols are saturate (they have no double bonds in the sterols ring) and are produced by hydrogenating sterols.

The FDA authorized the use of labelling health claims for foods containing plant sterol esters, including beta-sitosterol, for reducing the risk of coronary heart disease (FDA, 2000). This rule is based on the FDA's conclusion that plant sterol esters may reduce the risk of coronary heart disease by lowering blood cholesterol levels. Phytosterols appear to inhibit the absorption of dietary cholesterol and the reabsorption (via the enterohepatic circulation) of endogenous cholesterol from the gastrointestinal tract. Consequently, the excretion of cholesterol in the feces leads to decreased serum levels of this sterol

A recent review concluded that plant sterols and stanols; reduce the risk of heart disease by one quarter (Law 2000). This is the reduction expected from the decrease in serum cholesterol. A randomized, double-blind, 3-group parallel, controlled study evaluated the influence of esterified plant sterols on serum lipid concentrations in adults with mild-to-moderate primary hypercholesterolemia (Maki et al. 2001). Results indicated that when combined with a standard cholesterol-lowering diet, use of a spread enhanced with phytosterols improved total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides as compared to a normal reduced-fat spread. In a separate RCT, margarine enriched with sterol-esters from soybean oil reduced plasma total- and LDL-cholesterol concentrations by 8-13% when compared to control (Weststrate and Meijer 1998).

Another possible effect of plant sterols is their antioxidant activity. It was found that the methanol extract of soybean oil, which has a strong in-vitro protective effect against DNA damage in human endothelial cell, contains phytosterols in addition to tocopherols, Thus based on results from in vitro studies and on human study, there is a possibility that plant sterols may possess antioxidant properties. Such as antioxidant protection could also benefit atherosclerosis (Berger et al, 2004). A recent paper explored the antioxidant properties of plant sterols (campesterol, B-sitosterol, stigmasterol) and reported that phytosterols themselves can act as an antioxidant in-vitro, a modest radical scavenger in solution, and physically as a stabiliser in liposomal membranes (SCF, 2002).

Policosanol has been reported to decrease total cholesterol and low density lipoprotein (LDL) cholesterol in male and female patients with elevated cholesterol. Outcomes of over 60 clinical trials have been reviewed in detail, and reports of cholesterol lowering are very consistent (Hargrove et al, 2003). Reports suggest that the plasma concentration of high-density lipoprotein cholesterol cholesterol (HDL) increases at a slower rate than LDL decreases, so that the LDL:HDL ratio significantly improves within 1 year (Hargrove et al, 2003).

On the basis of the primary efficacy variable (ie, the change in LDL-C), treatment with Policosanol was effective. This study shows that Policosanol (5mg/d) administered for 8 weeks was effective in decreasing LDL-C in patients with borderline to mildly elevated serum TC values (Castano et al.,2003).

True waxes are defined chemically as esters formed between long chain fatty acids and long chain alcohols. The human diet has always contained modest levels of waxes. Beeswax or honeycomb is the richest natural dietary source of long chain aliphatic alcohols (Hargrove et al, 2003).

Preclinical studies have demonstrated that Policosanol administered orally for 4 weeks to normocholesterolaemia rats, partially prevented in vitro and in vivo microsomal lipid peroxidation and inhibited lipid peroxidation of lipoprotein fractions containing LDL-C + VLDL-C (Menendez et al, 2000). In another Clinical trial was found that policosanol administered at doses (5 and 10 mg day) within its conventional dosage as a lipid-lowering drug decreased the susceptibility of LDL-C to metal ion-dependent and macropague-mediated lipid peroxidation (Menendez etal, 2000).

Researchers have studied the lipid lowering effects of policosanol in a wide variety of subjects including healthy volunteers and patients with hypercholesterolemia have shown policosanol to have lipid lowering effect (Herman, 2004).

References:

1. Berger A, Jones P, Abumweis S. Plant sterols: factors affecting their efficacy and safety as functional food ingredients. Lipids in Health and Disease 2004: 3(5).
2. Castano G, Tula L, Canetti M, et al. Effects of policosanol in hypertensive patients with type II hypercholesterolemia. Curr Ther Res 1996;57:691-5.
3. Food and Drug Administration (FDA) . Food Labelling: health claims; Plant Sterol/Stanol Esteres and Coronary Heart Disease. 2000.
4. Hargrove J, Greenspan P, Hartle D. Nutritional Significance and Metabolism of Very Long Chain Fatty Alcohols and Acids from Dietary Waxes. University of GeORGIA 2003;215-226.
5. Herman D. Policosanol: A non-prescription Dietary Supplement to Control Hyperlipidemias. 2004. Volume 15 Issue 2.
6. Law M. Plant sterol and stanols margarines and health. British Medical Journal 2000;320;861-864.
7. Menendez R. Mas R, Amor A, Gonzalez R, Fernandez J, Rodeiro I, Zayas M, Jimenez S. Effects of Policosanol treatment on the susceptibility of low density lipoprotein (LDL) isolated from healthy volunteers to oxidative modification in vitro. Journal Clinical Pharmacology 2000;50;255-262.
8. Patch C, Tapsell L, Williams P, Gordn M. Plant sterols as dietary adjuvants in the reduction of cardiovascular risk: theory and evidence. Vascular Health and Risk Management 2006:2(2) 157-162.
9. Scientific Committee on Food (SCF). General view of the scientific committee on food on the long-term effects of the intake of elevated levels of phytosterols from multiple dietary sources, with particular attention to the effects of B-Carotene. Commission E. Brussel, Belgium 2002

Additional References

1. Hormones / Menopause
   Policosanol prevents bone loss in ovariectomized rats.
   Noa M, Más R, Mendoza S, Gámez R, Mendoza N, González J.
   The purpose of this study was to determine whether policosanol could prevent bone loss in the bones of ovariectomized rats by comparing its effects with those induced by estradiol (sex hormone). In conclusion, policosanol prevented bone loss and decreased bone resorption in ovariectomized rats, suggesting that it should be potentially useful in preventing bone loss in postmenopausal women.
   Drugs Exp Clin Res. 2004;30(3):117-23.
2. Effects of soy protein and isoflavones on circulating hormone concentrations in pre- and post-menopausal women: a systematic review and meta-analysis.
   Hooper L, Ryder JJ, Kurzer MS, Lampe JW, Messina MJ, Phipps WR, Cassidy
   A.
   Isoflavone-rich soy products decrease follicle-stimulating hormone (FSH) and luteinizing hormone (LH) in premenopausal women and may increase estradiol (sex hormone) in post-menopausal women. The clinical implications of these modest hormonal changes remain to be determined.
   Hum Reprod Update. 2009 Mar 19. [Epub ahead of print]
3. Impact of soy supplementation on sex steroids and vascular inflammation markers in postmenopausal women using tibolone: role of equol production capability.
   Törmälä R, Appt S, Clarkson TB, Mueck AO, Seeger H, Mikkola TS, Ylikorkala O.
   Soy modified the concentrations of estrone, testosterone and some endothelial markers. Soy supplementation may be clinically significant in tibolone (synthetic hormone-type drug).
   Climacteric. 2008 Oct;11(5):409-15.
4. New equol supplement for relieving menopausal symptoms: randomized, placebo-controlled trial of Japanese women.
   Ishiwata N, Melby MK, Mizuno S, Watanabe S.
   Equol, a metabolite of the isoflavone daidzein, is hypothesized to play a major role in the health benefits of soy. S-equol supplement improved mood-related symptoms in perimenopausal/postmenopausal equol nonproducers.
   Menopause. 2009 Jan-Feb;16(1):141-8.
5. Effects of soy protein isolate and moderate exercise on bone turnover and bone mineral density in postmenopausal women.
   Evans EM, Racette SB, Van Pelt RE, Peterson LR, Villareal DT.
   In postmenopausal women soy protein isolate reduces bone turnover with no impact on bone mineral density over 9 months.
   Menopause. 2007 May-Jun;14(3 Pt 1):481-8.
6. Androstenedione production by biotransformation of phytosterols.
   Malaviya A, Gomes J.
   Androstenedione is a key intermediate of microbial steroid metabolism. It belongs to the 17-keto steroid family and is used as starting material for the preparation of different steroids. Androstenedione can be produced by microbial side chain cleavage of phytosterol, which is an alternative to multi-step chemical synthesis.
   Bioresour Technol. 2008 Oct;99(15):6725-37. Epub 2008 Mar 10. Review.
7. Endurance / Athletes
   Octacosanol supplementation increases running endurance time and improves biochemical parameters after exhaustion in trained rats.
   Kim H, Park S, Han DS, Park T.
   exercise-trained control group (EC) rats ran 184% longer until exhaustion than sedentary control group rats, while octacosanol-supplemented trained rats ran 46% longer than EC rats.
   J Med Food. 2003 Winter;6(4):345-51.