Swedish firm Greenleaf Medical AB is poised to lodge an article 13.5 health claims submission to EFSA for its weight management ingredient Appethyl, on the back of positive clinical trial results.
In an exclusive interview with Nutraingredients, Dr Dan Edwall, VP R&D with Greenleaf, disclosed that following the completion of a clinical trial that “ yielded clear and significant results” for weight loss, a dossier for a weight loss claim for the spinach extract was being put together for submittion to the European Food Safety Authority (EFSA).
“Our first application for EFSA article 13.5 is about to be finalised and submitted this spring,” he said.
Edwall's revelation coincides with Greenleaf presenting the outcome of a new clinical trial on the appetite suppression effects of Appethyl at the Winter Meeting of Society for the Study of Ingestive Behaviour in Switzerland.
The study, which was carried out by a team of researchers led by Professor Charlotte Erlanson-Albertson at Lund University, suggested that the active components in Appethyl, known as thylakoids, can curb cravings for sweet foods.
“We have found that retarded fat digestion through the consumption of thylakoids from green plants produces satiety hormones such as CCK," wrote Erlanson-Albertson in an abstract of the study, which is currently being prepared for submission to a peer-reviewed publication.
"In this study we wanted to investigate whether the distal gut hormone GLP-1 is also released and if the urge for palatable food is affected."
Thirty six overweight women aged 40-65 took part in the three-month weight loss intervention study. At breakfast, participants received a daily blueberry shot with and without 5 g of Appethyl.
On the first and last day of the study, blood glucose, insulin and GLP-1 were measured over the period of six hours after breakfast. At the same time, the urge for sweet, fat and salt were assessed usin the Visual Analogue Scale (VAS). Six hours after breakfast, lunch was served. Thereafter the subjects continued to measure their urge for sweet, fat and salt.
The urge for sweets was significantly suppressed by Appethyl after just the first dose (day 1). On the last day of the study this suppression was even stronger and continued throughout the entire day, said the team behind the study.
GLP-1 was not significantly changed on day one, but on the last day there was a significantly increased release of GLP-1 in subjects taking thylakoids compared to control, they revealed.
The researchers concluded that the suppression of sweet taste may be coupled to the release of GLP-1 and that this release occurs through delaying food digestion as thylakoids temporarily inhibit pancreatic lipase for about two hours.
Asked what the next research step would be, Erlanson-Albertsson told Nutraingredients: “We will establish if the suppression of sweet leads to a diminished eating of sweet food, and palatable food in general.”
Keeping an eye on the prize
This study is part of Greenleaf’s broader research programme, which is carefully structured with an eye on winning EU health claims.
“We have planned our clinical study protocols according to EFSA guidelines and in addition to the weight loss claim, will apply for appetite suppression and weight maintenance claims,” confirmed Edwall.
He added: “The academic research programme on Appethyl at Lund University has documented some very interesting prebiotic effects of the product and additional interesting new effects we intend to develop further.”