Winter 2000 Issue — Bovine Colostrum
A New Performance Enhancing Supplement

Jeroen J.M. Vanden Berg

Numico Research Centre

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Introduction

The formulation of a nutraceutical product deriving its bioactivity from specific proteins presents distinct challenges. Firstly, keeping the proteins of interest in a non-denatured state is a technological challenge. Regular processing conditions employed during purification and manufacturing (extraction, spray-drying, sterilization) denature and deactivate many bioactive proteins to a large extent. Secondly, it is important to document and control the composition and biological activity of the protein or protein mixture. This article reviews the development of a bioactive bovine colostrum powder to illustrate how advances in processing technology can form the basis for a commercial protein supplement with documented bloactivity.

Bovine colostrum: background

Colostrum is the milk secreted by mammals during the first few days after having given birth. It is a highly complex biological secretion and a rich source of vitamins, minerals, bioactive proteins including lactoferrin. other antimicrobials, enzymes, growth factors and immune enhancing factors. These components have numerous effects on the body from stimulating tissue growth and repair (including bone and muscle) to protecting against infection until the infant can develop its own immunity. In addition, there are other compounds present in colostrum whose complex functions in the body are yet to be fully characterised and understood.

Research on bovine colostrum started several years ago initially mainly focussing on immunity. Since, in addition to immunoglobulins and lactoferrin, colostrum also contains growth-enhancing factors, sports performance became another potentially interesting objective. An important step in research was the development of a reproducibly high quality colostrum powder.

Intact™ Colostrum: Processing Considerations

Colostrum is a very variable material and its quality is based on the content of its bioactive proteins, in particular immunoglobulins (IgG), lactoferrin, and growth factors. The quantity and quality of these components impact significantly on the final colostrum product made available to the consumer. Quantity is determined mainly by the method and timing of the colostrum collection from the cow in relation to the time from calving as early milkings contain the most abundant amounts of these bioactive proteins. Important determinants of quality are the collection and storage temperatures of the colostrum on the farm and the downstream processing which the colostrum subsequently undergoes. Inadequate refrigeration on farms will cause a dangerous build-up of bacteria (and possibly resultant toxins), necessitating extra processing such as undesirable chemical or high heat treatment to reduce them to a low level. Exposure to high temperature, e.g., standard pasteurisation, will heat damage or denature the proteins irreversibly. NorthField Laboratories Pty Ltd has spent more than 10 years in developing a process to maintain the biological value of the colostrum products without the use of high heat. In the patented process, colostrum is LTLT (low temperature, long time) heat-treated, separated in a standard dairy separator to remove fat, and centrifuged (14,000 g) to further reduce the bioburden. This enables greater than 99.9% reduction of microbiological flora with a resultant colostral supernatant that generally is better that produced by standard pasteurisation. The centrifuged colostrum can also be further concentrated or fractionated for inclusion in dairy or other food products. Ultrafiltration of colostrum significantly increases the protein content of the retentate, where a majority of the bioactive components can occur. Spray drying under controlled conditions does not denature antibodies or other bioactive proteins in colostrum, and is therefore a more economical process than freeze-drying. The latent heat of drying prevents the atomized droplets from reaching a temperature that would lead to protein denaturation (Scammell et al. 1999). This process is carried out in a hygienic facility compliant with the code of pharmaceutical good manufacturing practice (GMP) to produce a product compliant with food standards and rigorous microbiological specifications. A detailed Hazard Analysis Critical Control point (HACCP) program is applied to maintain control and to comply with AQIS export establishment requirements. NorthField Laboratories is the only pharmaceutically registered plant in the world that produces and exports bovine colostrum products. A simple process flow chart is illustrated below: The resultant product obtained with this technique is a low fat, low lactose, concentrated bovine colostrum protein powder called Intact™. As described below, this product has undergone scientific testing and evaluation to ensure its clinical effectiveness.

Bioactivity of intact™

The final colostrum product was subjected to thorough compositional analysis, e.g., the amino acid composition is known in detail. In addition, biochemical analyses and specific bioassays confirmed that proteins of interest (immunoglobulins, growth factors, lactoferrin) are present in an essentially non-denatured conformation capable of displaying bioactivity in vitro. Routine analysis of immunoglobulin, for example, is done by HPLA using a protein affinity column which measures both native and denatured protein levels. With these basic characteristics of intact™ colostrum established and under control, human trials were conducted to assess the bioactivity of the product in vivo.

In order to assess the bloactivity of intact™ colostrum, several supplementation trials were set up in healthy volunteers with physical performance and recovery after exercise as output parameters. These supplementation trials were designed as placebo-controlled (i.e. half of the voluntee. use intact™ colostrum, whereas the other half receives a whey protein product containing the equivalent amount of protein), double blind (i.e. neither the volunteer himself nor the investigator/coach knows who is getting placebo and who is getting the colostrum product) studies. This scientific study design ensures the product is tested on its merits and without bias. The studies must also be approved by the relevent institutional ethics committee for scientific merit and ethical considerations. The first placebo-controlled trial with intact™ colostrum was performed using healthy, fit volunteers in which running performance was tested using 2 incremental treadmill-running tests to exhaustion separated by 20 minutes of recover. Buckley et al. 1998). The whey and the intact groups exhibited similar increases in the distance covered and work done from weeks 0-4 of supplementation (60 g/day) but, from weeks 4-8 the intact™ colostrum group continued to improve whilst the performance of the placebo group plateaued, such that by week 8 the colostrum group ran significantly further and did more work than the placebo group. A second trial involved health volunteers who were supplemented for 8 weeks with either the colostrum product or the whey (Buckley et al. 1999a). After the supplementation period, vertical jump performance increased at least twofold in men who consumed intact™ colostrum versus they whey protein supplemented group. This increase was also statistically significant (p=0.004). Athletes in both trials described above tended to exhibit reduced muscle damage after colostrum versus whey supplementation. In the runners trial, colostrum-supplemented athletes experienced improved recovery as indicated by 21% greater post-recovery running performance (p=0.04).

Another preliminary study involved scholarship rowers who completed a nine-week training program while consuming either 60 grams per day of intact™ colostrum or whey protein (Buckley et al. 1999). After 9 weeks of training, the intact™ colostrum group showed a greater improvement in work done compared to the placebo group (p=0.004). The athletes in this study who consumed colostrum experienced less viral and bacterial illness than those supplemented with whey. A double blind, placebo controlled study using elite field hockey players showed that also highly trained athletes supplemented with colostrum can achieve enhanced performance (Smeets et al. 2000). The study had two goals, namely measuring the effect of colostrum on high muscle power performance and endurance performance. All subjects consumed either 60 g/day of intact™ colostrum protein powder or whey protein powder during the first 8 weeks of competition season. There were no differences in the endurance tests during the 8 weeks of supplementation, but the improvement in the 5 x 10 metres sprint was significantly better in the colostrum compared to the whey group (p=0.023). A recent study from the University of Tasmania, Australia has reported that eight weeks of colostrum supplementation resulted in an improvement in cycling performance. These findings were presented in September at the Pre-Olympic Sports Medicine Conference in Brisbane (Coombs et al., 2000). Compared to their initial performance right eight weeks earlier the placebo group improved their performance by 37 seconds, the group taking 20g/day colostrum completed the time trial 158 seconds faster and the subjects taking 60g/day were 134 seconds faster. The improvements in both the 20g colostrum/day and the 60 g colostrum/day groups were statistically better (p=0.02) than the improvement in the placebo group time. The researchers concluded that taking either 20g or 60g/day of colostrum significantly improved cycling performance compared to subjects taking whey protein.

Conclusion

The above findings with intact™ colostrum supplementation show significant improvements in performance at 60g per day over 8 weeks (and one at 20g for 8 weeks) than when using whey protein as an isocaloric and iso-proteneous placebo. Similar results were obtained using healthy volunteers and top-athletes with their sports-specific endpoints. Moreover, although these findings have to be confirmed, it appears that intact colostrum not only enhances performance, but also provides protection against tissue damage by heavy exercise, allowing faster recover of athletes.

Interest in colostrum continues to grow and it appears beneficial to athletes and coaches to examine its usefulness as an ergogenic aid. At this point, technological advances in colostrum processing have enabled the production of a colostrum protein powder with key components in a biologically active form as indicated by laboratory and human testing. Given the complex nature of colostrum and the science of exercise physiology, perhaps it is not surprising that the exact mechanisms of the observed effects are still be to understood and therefore continues to be the objective of research by Numico Research and its collaborators.

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