Published in the Journal of Affective Disorders, the study began in 2016 after years of research on Slimaluma's effects on hunger, satiety, appetite regulation and weight management, beginning in 2001.
The first clinical study was conducted in 2003, followed by the product's 2004 launch as an appetite suppressant. It has since achieved FDA certification and GRAS (generally recognised as safe) status.
Stress and satiety: A circular relationship
Speaking to NutraIngredients-Asia, MD RV Venkatesh said: "We have been selling the product as an appetite suppressant, and the feedback we got from people who had used it was that their mood also improved.
"So we did some research on hunger and anxiety and found they were linked: hungry people tended to also be anxious. We then conducted an animal study, and the animal model showed good improvement in nootropic activity — there was significant reduction in anxiety and stress.
"We then started considering what sort of human study we should be doing on Slimaluma. Coincidentally, we received a request from Victoria University to use our extract for hunger control in Prader-Willi Syndrome (PWS) in a study they were conducting."
PWS is a genetic disorder in children and adolescents for which no cure has been found. Easily stressed and anxious, sufferers are especially sensitive to hunger and are therefore prone to extreme mood swings with regards to food and satiety.
Venkatesh said, "Kids with PWS can be ravenously hungry and I've seen how pitiable they are — at the sight of food, they go berserk. The mere smell of food stresses them out."
The daughter of a researcher at Victoria University had PWS, and the researcher requested Slimaluma from her colleagues so she could use it to alleviate her daughter's condition.
She later reported that the girl's moods and appetite returned to normal after taking Slimaluma, prompting her to conduct a study involving a population of children with PWS in Australia. The results were generally positive, with the product helping to balance the participants' cortisol levels, appetite and overall mood.
Venkatesh said, "We worked closely with the university as we felt we should contribute to making the lives of children with PWS better.
"Even for people without such a condition, it's a vicious cycle: when they are hungry, they feel stressed. When they are stressed, they crave a sugar rush and eat (junk food) due to their higher cortisol levels."
Method and mechanism
He further said, "We were quite surprised that in terms of human data, this was the first product to have been reported as effectively acting against PWS. It calmed them down and helped control their hunger, so the researcher was quite keen to understand the underlying mechanisms of this effect.
"Her preliminary studies showed that the extract acted on the brain's serotonin receptors, which control both satiety and anxiety. That prompted us to want to conduct a human clinical study to see if we could focus on the anxiety factor.
"While we were debating what kind of study we should conduct, we received another request, (this time) from the University of the Sunshine Coast, where a researcher was doing work on anxiety.
"He had read our animal study paper and was quite impressed with the data. The university was providing a grant for a study on anxiety and he chose our product. We then sponsored the laboratory test kit to test the stress hormone cortisol."
The study, conducted on a healthy adult population, found that through its effect on the brain's serotonin receptors, Slimaluma reduced anxiety and stress, and led to a feeling of well-being in the participants.
Formats and future plans
Slimaluma currently comes in tablet, capsule, and water-soluble powder form, with potential delivery doormats including shots, effervescent tablets, and shakes.
Venkatesh believes it has significant supplement and functional food potential, and Gencor is involved in "ongoing discussions with multiple customers about the potential of Slimaluma for the hunger-anxiety axis, so as to help people deal with problems of binge-eating, stress and other related issues".
The firm also plans to conduct further clinical studies on Slimaluma's effects on both appetite and anxiety, as well as its underlying mechanisms, with the long-term goal of creating a new supplement and functional food category that combines weight management with stress management.
Venkatesh said, "So far, anti-stress supplements and weight management or appetite regulation products have remained in separate categories. We want to introduce a new concept where the two go hand in hand, as they are connected.
"People who try to lose weight tend to feel irritable from eating less. We want to give them a way to feel good despite reducing their meal portions, by helping them achieve satiety easily.
"The extract is already available in supplements in the satiety and weight management sectors, and we are looking to move into the stress and anxiety management sectors as well. We believe this could be used in a broad-spectrum treatment for weight management and anxiety."
Slimaluma is currently being used in products in the US, Canada, Japan, Australia, Europe, and South East Asia. Gencor intends to expand its market presence further to completely cover the latter region, where people have become increasingly health-conscious and stress levels tend to be high, especially among urban populations.