Nicolas Tzenios, creator of “KetoTv” and Chairman of TRCGEN+ medical research hub, has signed on to conduct a clinical trial with KGK Science Inc. He hopes to prove that elevated glucose, rather than fat, is to blame for the onset of cardiovascular and diet-related diseases.
Many of us have heard of the Keto Diet, a dietary suggestion of high-fat, low-carb foods involving a combination of intermittent fasting, mindful eating, and an emphasis on organic products. And while this is not an FDA-approved medical treatment, there is something to it. However, because of limited research data, medical researchers are unsure what that is.
The History & Evolution of Keto
While diets similar to or reflecting the keto diet have been around for some time, the ketogenic diet was originally discovered in 1921 by Dr. Russel Wilder, MD, of the Mayo Clinic, originally used as a treatment for epilepsy. The diet has affects on more than just the patients’ seizures, though, making it into what it is today: a dietary fad. This high-fat, low-carb method of eating has captivated popular culture, and more people than ever are wondering whether it will make a difference for their health.
Other Clinical Trial Findings
Affects on Type 2 Diabetes
At the Temple University School of Medicine in Pennsylvania, researchers concluded that “In a small group of obese patients with type 2 diabetes, a low-carbohydrate diet followed for 2 weeks resulted in spontaneous reduction in energy intake to a level appropriate to their height; weight loss that was completely accounted for by reduced caloric intake; much improved 24-hour blood glucose profiles, insulin sensitivity, and hemoglobin A1c; and decreased plasma triglyceride and cholesterol levels. The long-term effects of this diet, however, remain uncertain.”
The University in Melbourne, Australia, also examined the effect of ketosis on a number of circulating factors involved in appetite regulation, following diet-induced weight loss. Researchers conclude that “The circulating concentrations of several hormones and nutrients which influence appetite were altered after weight loss induced by a ketogenic diet, compared with after refeeding. The increase in circulating ghrelin and subjective appetite which accompany dietary weight reduction were mitigated when weight-reduced participants were ketotic.”
In pre-clinical trials, or in rodents, researchers at UCSF found that “ketogenic diets – and caloric restriction, in general – are known to reduce inflammation, improve outcomes after brain injury, and even extend lifespan. These benefits are less well-established in humans, however, in part because of the difficulty in maintaining a ketogenic state.”
What Others Are Saying
Marcelo Campos, MD, of Harvard Medical School, states in a Harvard Health Blog: “A ketogenic diet could be an interesting alternative to treat certain conditions, and may accelerate weight loss. But it is hard to follow and it can be heavy on red meat and other fatty, processed, and salty foods that are notoriously unhealthy. We also do not know much about its long-term effects, probably because it’s so hard to stick with.”
But he goes on to say that “It is also important to remember that ‘yo-yo diets’ that lead to rapid weight loss fluctuation are associated with increased mortality. Instead of engaging in the next popular diet that would last only a few weeks to months (for most people, that includes a ketogenic diet), try to embrace change that is sustainable over the long term.”
According to Ethan Weiss, MD, an associate professor at the Cardiovascular Research Institute at the University of California San Francisco, “One big hurdle to the knowledge about the keto diet’s impact on humans is that many of the benefits – helping reduce inflammation in the brain, improving outcomes after brain injury and extending lifespan – have only been found in studies in mice.
“Far fewer clinical studies have been done in humans outside of seizure prevention since ketosis is a difficult state to maintain; avoiding carbs, including fruit, bread, legumes, and the occasional office birthday cake isn’t feasible for many people in the long run.”
Though the ketogenic diet has proven benefits for much of the population, the eating plan isn’t recommended for everyone. Specifically, those taking insulin for type 1 diabetes, have high blood pressure, or are pregnant or breastfeeding are at high risk of ketoacidosis from following the ketogenic diet.
Ketoacidosis is a dangerous health condition that is caused by an excessive buildup of ketones in the body, and it can lead to nausea, high blood sugar levels, extreme thirst, and debilitating fatigue.
However, the researchers at UCSF agree that the diet itself isn’t inherently dangerous. But, cautions Weiss, “If you have any medical condition, if you take any medicine at all – there are lots of things that change how medicines work in our bodies, and nutrition is definitely one of them. If you’re making a real change in your nutrition, you really should talk to your doctor.”
Tzenios Comes In
Nicolas Tzenios has signed on to conduct a keto diet clinical trial with KGK Science Inc. With this research, Tzenios hopes to prove that elevated glucose, rather than fat, is to blame for the onset of cardiovascular and diet-related diseases. If corroborated, his theory has the potential to greatly impact the realm of dietary science.
Tzenios is also applying to patent his ‘Friendly LDL Theory.’ This concept is inspired by the success of the keto diet, which involves the ingestion of high-fat, low-carb foods. And Nicolas is an expert in this field, having created literature and courses surrounding “Nic’s Keto Diet,” which also involves a combination of intermittent fasting, mindful eating, and emphasis on organic products.
In their press release, however, it is claimed “The Institutional Review Board (IRB) (The Canadian equivalent to the FDA) approved to proceed with Nicolas Tzenios Clinical trial.” This is not an accurate statement. An IRB is similar to an ethics committee and does not in any way relate to the Canadian FDA.
While we acknowledge there’s a lot of promotion around the Keto Diet, there are serious factual inadequacies in their press release—causing us to question their true knowledge of the subject and their intention towards the public.
More on Nicolas Tzenios
Nicolas is a former vice Rector of a State Medical University, believing that education is a nonstop lifelong journey. Nicolas is back to the benches of the university, studying post-doctoral, postgraduate high impact cancer certificate at Harvard Medical School.
About KGK Science Inc.
As a global Contract Research Organization (CRO), KGK Science performs a productive and pioneering role in the realm of scientific study. For over two decades, it has offered well-designed, customized solutions to each of its clients, consolidating its scientific, clinical, commercial, and regulatory abilities into one full-service package. Equipped with state-of-the-art technologies, novel research techniques, and a seasoned team of thought leaders, KGK Science remains at the forefront of its industry. And, by seamlessly matching its experience with its drive for innovation, this CRO is able to respond effectively to expanding trade and consumer demands.
Call to Action: Make sure to speak to your physician and do your research about the Keto diet if you’re interested in changing your dietary habits.You can also sign up for TrialSite News’ Daily Digest for future updates on dietary science involving clinical trials.