Called Clock, the ingredient is a patent pending mixture of Rosmarinus officinalis and Daylily Hemerocallis fulva that arose out of research done by Dr Bolin Qin, MD the University of Maryland School of Medicine in conjunction with teh Beltsville Human Nutrition Research Center.
The first effect of the mixture discovered by Dr. Qin, a native of China who received his medical training in Japan, was its effects on the body’s circadian clock proteins. This was first validate by private research funded by the developer, IN-Ingredients, that demonstrated the mixture helped regulate the expression of circadian clock proteins in C6 animal brain glioma and IPEC-1 cells. Following that a pilot study was done showing positive results in humans followed by two published placebo controlled human clinical trials.
Focus on biomarkers
Judi Quilci Timmcke, PhD, vice president of product development for the company said one things that sets the research on the ingredient apart is Dr. Qin’s focus on identifying specific biomarkers that can be measured to quantify effects. In the most recent study, which included more than 30 subjects and featured a crossover design, the team led by Dr. Qin looked at the upregulation of acetylcholine, choline, Brain Derived Neurotrophic Factor (BDNF), irisin and melatonin. Quilci Timmcke noted the focus on irisin in particular as a measure of how advanced the research planning has been. Irisin is a fairly recently discovered signally hormone.
“Dr, Qin’s work has been focused on cutting edge biomarkers,” Quilci Timmcke told NutraIngredients-USA. “We believe no other company is doing anything like this.”
The study also found statistically significant effects on measures of cognitive health such as attentiveness, alertness and focus. Quilci Timmcke said that while the initial focus was on circadian rhythms, the product positioning will probably more naturally fall as a cognitive support ingredient rather than as a straight sleep aid, though participants in the company’s studies have reported in an anecdotal fashion feeling more refreshed after sleep, she said.
“I would consider it a nootropic because it affects brain function but it meant to be taken pre sleep,”she said.“If I were going to formulate with this product today, I would position it for cognitive function. Every organ in the body is affected by circadian rhythms. But it could also function in anti aging ingredient because we know that BDNF and irisin decline with aging.”
The product has been in soft-launch mode in the United States, Quilci Timmcke said. With two placebo controlled trials in hand, marketers will have some margin of security with regard to the Federal Trade Commission when it comes to supporting claims. The company will be meeting with prospective clients at the upcoming Supply Side West trade show at the end of the month, she said.