Sunday 11 November 2012

South Africa’s interfirm biotech networks versus the World


Participant Information sheet 


Investigators:  Paul Voigt, Dr. Timothy Kastelle

Objectives:  We want to understand how the medical biotechnology firms in South Africa work together and with other parties. This information will be compared to some of the biotechnology hotspots around the world, namely San Diego, Boston, Cambridge and Munich. It is hoped that this information would help align the companies in South Africa to strategies employed by these highly successful hubs.

This research will be conducted through face-to-face interviews (where possible). These interviews will consist of open-ended questions which participants are free to choose not to answer and will take place in the interviewee’s offices, or preferred location. These interviews will be recorded and transcribed for future reference, however all information used in publication, or any reporting, will be completely anonymous. The surveys themselves will take approximately an hour.

Interviewees are under no obligation to participate and may withdraw at any time.  Only aggregated results will be reported.

If you participate in this study, the information will not be linked back to you as an individual.  The information will be stored in a secure environment and access to the data will be made available only to the members of the research team, i.e. Paul Voigt and Dr. Tim Kastelle.  Your comments will be kept confidential and any information provided will only be used for the purposes of this research.

You are welcome to discuss your participation in this study with the student, Paul Voigt (+27722646507, paul @ veabiological.com) or his/her academic advisor, Dr. Tim Kastelle (+61 7 3346 8158, t.kastelle @ business.uq.edu.au) or to impose conditions, or withdraw from the study at any time.

This study adheres to the Guidelines of the ethical review process of The University of Queensland. Whilst you are free to discuss your participation in this study with project staff if you would like to speak to an officer of the University not involved in the study, you may contact the Ethics Officer on +61 7 3365 3924.

Regards


Paul Voigt
Doctor of Biotechnology candidate at the University of Queensland
Principle investigator

Tuesday 4 September 2012

Dipstick tests to measure physiological parameters



Non-invasive semi-quantitative dipstick tests intended to measure selective physiological parameters in individuals involved in weight loss, sport and training programmes

More than 1.6 billion people in the world are either overweight or obese, according to a recent study by the World Health Organization. People are considered overweight if their body mass index (BMI) is 25 or higher and obese with a BMI or 30 or higher.


RANK
COUNTRY
%  OVERWEIGHT OR OBESE
1
Nauru
94.5
2
Micronesia
91.1
3
Cook Islands
90.9
4
Tonga
90.8
5
Niue
81.7
6
Samoa
80.4
7
Palau
78.4
8
Kuwait
74.2
9
USA
74.1
10
Kiribati
73.6
11
Dominica
71
12
Barbados
69.7
13
Argentina
69.4
14
Egypt
69.4
15
Malta
68.7
16
Greece
68.5
17
New Zealand
68.4
18
United Arab Emirates
68.3
19
Mexico
68.1
20
Trinidad and Tobago
67.9


Excess intake of carbohydrates results in fat storage. Simple carbohydrates, such as sugar and white flour, rapidly spike insulin levels, thereby accelerating the conversion of carbohydrates to fat. Through low carbohydrate diet the body’s carbohydrate intake is restricted altogether, and is forced to rely on its fat stores for energy. During diet and exercise the body breaks down stored fat for fuel and hence the weight loss process begins. It is during this fat-burning process that ketone bodies are produced and excreted in the urine. Ketones are metabolic by-products of fat metabolism.

A newly developed urinary dipstick test with selective parameters can accurately detect certain physiological parameters in the urine and be a great aid for people who want to monitor their weight loss or diet progress.

Test results 

The test is performed by dipping a chemically impregnated dipstick into a urine sample or by urinating directly onto the dipstick.

If acetoacetic acid and/or b-hydroxybutyrate is present in the urine, even in trace quantities, a purple colour reaction will develop on the dipstick. This colour is measured against a colour chart after 30-60 seconds. Any purple colour development on the test strip is indicative of a positive reaction – i.e. ketones are present and therefore fat-metabolism is taking place. If no purple colour is present then no ketosis is taking place and the body is using glucose for fuel (glucolysis – converting glucose into pyruvate). Appropriate action can then be taken (i.e. decrease carbohydrate intake, increase exercise, etc)


Similarly, the test also contains a chemically impregnated area which measures the specific gravity (hydration status) of the individual. The colour is measured against a colour chart after 30-60 seconds. A dark blue/green reaction indicates that the individual is well hydrated, whilst lighter green/yellow colours indicate that the individual could be dehydrated. Appropriate action can then be taken if necessary.



Chemistry behind the test

Ketones
The liver is considered the major source of ketone bodies (KB) in humans. Ketone bodies are three water-soluble compounds that are produced as by-products when fatty acids are broken down for energy in the liver and kidney. They are used as a source of energy in the heart and brain. In the brain, they are a vital source of energy during fasting. Although termed "bodies", they are dissolved substances, not particles. The three endogenous ketone bodies are acetone, acetoacetic acid, and betahydroxybutyric acid.

Ketone bodies can be used for energy. Ketone bodies are transported from the liver to other tissues, such as muscle, where acetoacetate and beta-hydroxybutyrate can be reconverted to acetyl-CoA to produce energy, via the citric acid cycle. As with muscles, the brain gets its energy from ketone bodies when glucose is less available (e.g., when fasting). In the event of low blood glucose, most other tissues have additional energy sources besides ketone bodies (such as fatty acids), but the brain does not. After the diet has been changed to lower blood glucose for 3 days, the brain gets 30% of its energy from ketone bodies. After about 40 days, this goes up to 70%.

Ketone bodies are produced from acetyl-CoA mainly in the mitochondrial matrix of hepatocytes when carbohydrates are so scarce that energy must be obtained from breaking down fatty acids. Because of the high level of acetyl CoA present in the cell, the pyruvate dehydrogenase complex is inhibited, whereas pyruvate carboxylase becomes activated. Thus, the oxaloacetate produced will enter gluconeogenesis rather than the citric acid cycle, as the latter is also inhibited by the elevated level of NADH resulting from ß-oxidation of fatty acids. The excess acetyl- CoA is therefore rerouted to ketogenesis. Such a state in humans is referred to as the fasted state.

Acetone is produced by spontaneous decarboxylation of acetoacetate, yielding levels of acetone much lower than those of other ketone bodies. Acetone cannot be converted back to acetyl-CoA; it is instead metabolized (e.g., converted to glucose via pyruvate, excreted in the urine, or (as a consequence of its high vapor pressure) exhaled. Acetone is responsible for the characteristic "fruity" odour of the breath of persons in ketoacidosis.

Any production of these compounds is called ketogenesis, and this is necessary in small amounts. However, when excess ketone bodies accumulate, this abnormal (but not harmful) state is called ketosis. Until recently, ketosis could be quantified by sampling the
patient's exhaled air, and testing for acetone by gas chromatography.

Specific gravity (SG)
A study conducted at the University of Washington found that drinking one glass of
water eliminated midnight hunger pangs in 98 percent of the subjects, thus decreasing caloric intake from midnight snacks. Water may also cause an increase in energy, allowing one to be sustained in-between meals or to push harder through workouts. The Journal of Clinical Endocrinology and Metabolism published a study in 2003 examining the thermogenic effect of water. Researchers led by Michael Boschmann found that consuming 2 glasses of water caused a 30 percent increase in metabolism, mostly attributable to the body warming the water to body temperature.

Proper hydration has long been regarded as an essential key to weight loss, but the ideal amount that one should consume is often in debate. Because water is inexpensive and easier to come by than many other weight loss methods, however, any reasons that suggest it may aid in weight loss are not taken lightly by those struggling to maintain an optimal weight. Various explanations exist for why hydration is so important. It is widely recognised that maintaining proper hydration is essential in all individuals who are involved in weight loss.

Solution

Now, a newly developed advanced 4th generation urine dipstick test can be employed as a very accurate marker of fat metabolism (burning fat) and hydration. This product, which incorporates molecular principles for the first time, detects the major ketone bodies b-hydroxybuterate and acetoacetic acid in urine, and can thus be used as a measuring tool for adherence to low-carbohydrate diet, or to verify the efficacy of an exercise programme in conjunction with diet. At the same time, it is an invaluable tool helping the individual to monitor and maintain optimal hydration through measuring the specific gravity of the urine, an essential component of any serious weight loss programme.

Indications and contraindications

The product is primarily indicated for individuals who want to monitor weight loss over a period of time. The test is done by regularly testing urine for the presence or absence of ketones and measuring the hydration status of the body. The product is not indicated for individuals who are anorexic or have tendencies towards anorexia or bulimia, individuals who are recovering from eating disorders and other gastrointestinal diseases or metabolic conditions. The product should not be used to diagnose any condition or illness and should not be used by children. It is advisable that the product be used when the individual is following a controlled weight loss programme backed by a low-carbohydrate diet.

Packaging

Presentation can be varied and may include the following options:
a. A plastic can with 25 strips;
b. Individually foil sealed strips, sold individually or in packs of 10’s, 20s etc
c. Any other over-the-counter (OTC) packaging.

The product is supplied with an instruction sheet. It can be decided by the buyer what level of information is provided, and preferably users should be guided to a website with more details. This product is offered with a 2-year shelf life when stored at room temperature. The product should not be refrigerated and should be kept away from direct sunlight.

Potential End Users

Overweight persons (on diet and/or training)
Obese persons (on diet and/or training)
Underweight individuals who want to add weight
Dieticians
Weight watchers (and similar programmes)
Other

SPORTS APPLICATIONS

A similar type urine dipstick test with specific appplication for application in sport has been developed. We are actively seeking interested parties to contact us for distribution, marketing, licensing, and invesment.


Contact  



Louis Roux
Managing Director

Tel: +27 21 788 6989
Fax: +27 21 788 6983
Cell: +27 83 267 2067

Life Assay Diagnostics (Pty) Ltd
Trojan House, Gateway Close
Capricorn Business & Technology Park
7945 Cape Town, South Africa