Did Rocky get it right?
The Eye of the Tiger
When I was first introduced to Fortetropin, I had a flashback to my childhood in Canada. When I was in fourth grade, my favorite movie of all time was Rocky with Sylvester Stallone. Rocky was a true champion who I continue to admire to this day. In 2005, when I was preparing for my Ph.D. oral defense, I used to listen to “Eye of the Tiger” to motivate myself. Like many people who are true champions in their respective fields, Rocky had some eccentric habits. One of them was the fact that Rocky used to drink raw eggs as part of his training regimen. Even back in 1976, Rocky understood that raw eggs can help one gain muscle. However, raw eggs can also make one very sick. Bacteria such as Escherichia coli, Staphylococcus aureus, Salmonella or Lysteria monocytogenes are not things to be taken lightly. As strong as Rocky may have been, Salmonella can take down a legendary boxer like Rocky faster than an uppercut to the jaw before he could even blink! Being a scientist, I would not eat raw eggs if my life depended upon on it. So why did Fortetropin make me have flashbacks of Rocky and listening to “Eye of the Tiger” during my formative years? Fortetropin is a natural product that can help people gain muscle, and it is made from egg yolk.
However, there are two fundamental differences from the wild concoction that Rocky drank back in ’76. First, Fortetropin is made from fertilized chicken egg yolk while the eggs that we buy in grocery stores here in the United States are typically unfertilized eggs. Fertilized chicken egg yolk is a fascinating liquid as it contains all of the nutrients needed to support the development of an embryo. Second, Fortetropin is pasteurized using a patented process that helps to maintain its natural bioactivity. (This process is discussed in detail in an earlier blog entry.) One of the steps involves using high pressure processing (HPP) technology, as opposed to heat, to pasteurize egg yolks. HPP is a highly effective method of pasteurization that destroys harmful microorganisms while maintaining nutrients intact. The second step of the Fortetropin manufacturing process involves a low temperature drying step known as freeze drying. By drying a substance at low temperatures, we avoid destroying many of the nutrients that are sensitive to heat. The beautiful, bright yellow egg yolk powder that we obtain is Fortetropin.
The Early Days
In the early days, one of the first studies that we did with Fortetropin involved gauging the impact of Fortetropin on levels of myostatin, a protein in the blood. Myostatin is a protein that “puts the brakes” on muscle growth and development. Why do we have a protein that circulates in our blood with the job of “putting the brakes” on muscle growth and development? Myostatin is there to keep our muscles in check with our bones. Without myostatin, if you were to work out on a regular basis and consume a healthy diet, you could probably gain as much muscle as Rocky. Although that may sound like a good thing, it is not a good thing if your bones cannot handle that much muscle mass — it’s critical to understand that Fortetropin does not block even close to all of the myostatin in your body. Instead, it decreases myostatin levels by twenty percent — enough that one is able to safely build muscle without risking bone issues. Still, as exciting as the results of our first study were, as a scientist, I knew that simply demonstrating a reduction in myostatin levels based on blood tests was not enough. We need to demonstrate that Fortetropin can help people build muscle safely.
Meeting the Muscle Professor
When I first met Dr. Jacob Wilson in early 2014, I thought that he was a professional athlete. Did he play NFL football or NHL hockey? No, Dr. Wilson is not an NFL quarterback like Tom Brady or an NHL legend like Wayne Gretzky. Dr. Wilson is a muscle physiologist (a scientist who studies muscle) and he has authored over 200 research articles, book chapters and abstracts. After earning B.S. and M.S. degrees in Exercise Nutrition and Exercise Physiology from California State University, East Bay, Dr. Wilson went to Florida State University, Tallahassee where he earned his Ph.D. in Exercise Physiology. Shortly after earning his doctorate, Dr. Wilson joined the University of Tampa as an Assistant Professor in the Department of Health Sciences and Human Performance.
The Human Performance Laboratory
In Dr. Wilson’s laboratory, one will find some of the most sophisticated equipment imaginable to study human muscle: equipment like ultrasound instrumentation to measure muscle thickness, dual-energy x-ray absorptiometry (DEXA) instruments to determine body composition, spectroscopy instrumentation to accurately measure muscle-related proteins in the blood and mechanically braked bicycle ergometers to measure power as part of a test called the Wingate Test, to name just a few. It was in this highly sophisticated, cutting edge laboratory that Dr. Wilson and his team of researchers demonstrated that taking Fortetropin on a regular basis can lead to significant muscle gains.
Designing a human clinical trial is a very complex process. The study that Dr. Wilson and his team performed is known as a double-blind, placebo-controlled human clinical trial. What does placebo-controlled mean? When people are given something that they are told will improve their health, they very often report feeling better even when they were given a sugar pill, or a pill that has no medical qualities that would have an impact on their health. This is called the ‘placebo effect,’ and doctors and scientists understand it very well. In this clinical trial, one group of subjects received a pudding mix that resembled Fortetropin in taste and appearance (the placebo). This was a very important part of the study as Dr. Wilson needed to know whether people taking Fortetropin were really gaining more muscle than people taking the placebo.
What does double-blinding mean? Does someone actually lose their sight in this study? Of course not. When people know whether they are in the “placebo group” or the “active group” of a clinical study, an element of human bias can take over. This can present a huge problem in studies that are trying to measure something very subjective like pain. If you know that you are in the “active group”, your brain may trick itself into thinking that you are feeling less pain because you are being given a medicine that is supposed to help reduce the pain even if that medicine doesn’t actually work at all. If the doctor or scientist running the human clinical study knows who is in the “active group” and who is in the “placebo group,” then they may become biased when it comes to reporting their scientific observations. That’s where double-blind studies, in which neither the participants nor the doctors or scientists know who is in which group, come in.
Randomizing and Inclusion/Exclusion Criteria
In clinical trials, it is important to assign people to different groups (i.e. placebo and active group) very carefully. Dr. Wilson had to make sure that all of the people participating in the clinical study were fairly similar to one another in a number of ways, so he came up with some “inclusion criteria,” characteristics that the participants were required to have in order to be eligible to participate. A few of his inclusion criteria were that the subjects had to be non-smoking men with ages between 18 to 21 years with a body mass of less than 100 kilograms. Dr. Wilson also came up with some “exclusion criteria,” characteristics that participants could not have if they wanted to participate in the study. Some of Dr. Wilson’s exclusion criteria were having a history of arthritis, joint pain, inflammation and cardiovascular disease, to name a few. Exclusion criteria are important because the study involved doing some exercise in addition to taking Fortetropin and he did not want someone who was ill to be performing exercise that could make their illness even worse. Also, if people are ill and they are taking part in a clinical nutrition study, it becomes impossible to figure out if their illness had any impact on their performance in the study or not.
Another important concept in clinical studies is randomization. Randomization is the concept of randomly putting people into different study groups (i.e. active arm vs. placebo arm) while making sure that the two groups are as similar as possible when it comes to the things that we are trying to study and measure (i.e. things related to muscle, fat and strength). In this study, Dr. Wilson tried very carefully to make sure that the different study groups had people in them with about the same muscle thickness, muscle mass, fat mass and muscle strength. If one group was much stronger than the other group, the deck would already have been stacked against Dr. Wilson as far as his ability to measure whether Fortetropin had any effect on the ability of the participants to gain muscle. Therefore, randomization is a central concept when it comes to designing clinical trials.
Fortetropin is a natural product designed to help people gain muscle, but people are unlikely to gain muscle if they are not doing any exercise at all. What Dr. Wilson really wanted to find out was if drinking a milkshake that had been spiked with Fortetropin every day helped people gain more muscle than what they could gain if they drank a milkshake that did not contain Fortetropin, but rather something similar to Fortetropin in terms of its nutrient profile (fats, carbs, protein). Dr. Wilson and his team developed an exercise program that everyone in the study was required to complete every Tuesday and Thursday for 12 weeks.
Does taking Fortetropin everyday while performing exercise help people gain more muscle? In order to answer that question, Dr. Wilson had to make a series of measurements. When you think about ultrasound machines, you probably think about pregnant women going to the doctor for the first time. Yet, ultrasound machines can be used by muscle physiologists to measure the thickness of a particular muscle. In order to figure out how much muscle, fat and bone someone has throughout their body, muscle physiologists use a sophisticated instrument called DEXA (dual-energy x-ray absorptiometry). It’s not enough to find out if people gained more muscle in a study; muscle physiologists like Dr. Wilson also want to measure the performance of muscles. They do this by having their subjects do bench presses and leg presses along with having them ride a bike at very high speed.
At the end of the 12 week study, Dr. Wilson and his team had to sort through all of data that they had collected from the study and crunch through a lot of numbers. In the end, after a lot of hard work and running through many calculations, Dr. Wilson and his team found out that participants in the study that were taking Fortetropin everyday did gain more muscle than participants taking the placebo.
What Comes Next?
Good scientists don’t just want to know whether or not something works. They really want to know how something works. In our next blog post, we will talk about how Dr. Wilson and his team figured out how Fortetropin helps people gain muscle.