Called Weighlevel One, the product has been under development for a number of years. In its original form, called Weighlevel, the product was a blend of extracts of leaves of Alchemilla vulgaris (Lady’s Mantle), Olea europea (olive), Mentha longifolia (wild mint) and from the seeds of Cuminum cyminum (the spice cumin).
Initial results promising
The product showed good results in some early clinical trials published around 2011, enabling subjects in the experimental groups to lose more weight in a statistically significant fashion than did placebo groups.
The blend has multiple forms of action including stimulating metabolism (Lady’s Mantle and olive leaf); suppressing appetite (Lady’s Mantle, cumin and wild mint); and easing digestion (cumin and wild mint). But in its original form the herbal constituents were cleared quickly from the system, requiring users to take a dose three times a day.
That seemed a non starter to Atlanta-based ingredient developer John Alkire, who was intrigued by the initial formula’s results. Alkire, who is the founder and CEO of Zanda LLC, which sells a variety of patented ingredients, suggested to Sprunk-Jansen, the Danish firm that developed the original formulation, that finding a way to extend the release profile so that the formula could be taken once a day would create a more commercially viable product.
Randi Kindem, marketing manager with Sprunk-Jansen, said Alkire contacted her company after the product had been on the market for a several of years.
Altering the delivery profile
Kindem said Eric Sprunk-Jansen, the firm’s founder, came from a long career in the pharmaceutical industry as did she. So they knew the challenge presented by consumer compliance in the overall performance of any product. And they knew, too, that the 3-times-a-day format wasn’t ideal.
So she said the company was intrigued when Alkire suggested combining the Weighlevel four herb blend with another ingredient in his stable branded as Propol, which is a patented konjack glucomannan purified, isolated fiber. The fiber is manufactured by Shimizu Chemical Corp. of Japan. The combo could extend the effect of the herbs so a once-a-day dosage form would be possible, he said.
That activity was validated in a second trial published recently in the International Journal of Herbal Medicine. Researchers recruited a cohort of health, middle aged subjects in Copenhagen who were satisfied with their weight but were also looking to lose weight.
Over eight weeks the group using Weighlevel One lost about 0.5 kg/week for a total loss of 4.2 kilograms on average. This represented an average weight loss of 4.9%, compared to a 0.9% weight loss in the placebo group.
The groups recruited for the study were not exceptionally overweight by North American standards. They averaged about 26 BMI, whereas in the US BMIs of 28 to 30 or more are common.
Kindem said Danish protocols restrict the use of technically seriously overweight individuals because obesity is considered a disease condition there, and such a study would therefore become de facto a drug study. But she said there’s no reason to believe the formula would perform differently in a more overweight group. And she said it’s crucial for a weight loss product to have ample safety and efficacy data, given the number of potential comorbidities in this consumer group.
“When you consider the other factors for this group such as hypertension, high cholesterol and other conditions, it’s extremely important you test a weight loss product for its safety and potential drug interactions,” she said.
Pharmaceutical background a plus
Alkire said his initial conversations with the Sprunk-Jansen team convinced him this was a viable partner for his business.
“They have a very serious technical background, and they have a knowledge of and passion for the herbal industry. And their relationship with the University of Copenhagen, and all of the botanical ID testing they do there, was really impressive,” he said.
Kindem said that with the backing of the new study results, the company expects sales to improve. And that is from an already thriving base level, where Alkire has placed the ingredient with a multi level marketing company as well as with a major retail partner. And there are reports of all the weight gained by consumers during the pandemic lockdown to figure into that mix.
“Since we started we have been selling about 20 metric tons of this ingredient yearly in the United States, and we presume this will increase by more than 50%,” she said.
Source: International Journal of Herbal Medicine
2021; 9(3): 71-75
A randomized, double-blind, placebo-controlled study of a once daily blend of herbal extracts for weight loss
Authors: Kassis E, Hansen PA