Influential Journal Recognizes Quality of Design and Execution of Gold-Standard Double-Blind Placebo-Controlled Study
MORRISTOWN, NJ – PLT Health Solutions, Inc. (Morristown, NJ) announced that the results of a clinical study the company helped develop has been published in the highly-regarded scientific journal, Diabetes, Obesity and Metabolism. Entitled “Efficacy of a novel herbal formulation for weight loss demonstrated in a 16‐week randomized, double‐blind, placebo‐controlled clinical trial with healthy overweight adults” (Dixit, et al 2018), the publication describes clinical evaluation of Slendacor Weight Management Complex, which was introduced to the market in 2017. The study, funded by PLT and Laila Nutraceuticals, has gained recognition in the natural products industry because of its rigorous design as well as its results documenting steady, consistent weight loss among other endpoints evaluated.
According to Dr. Barbara A. Davis, Vice President, Medical & Scientific Affairs for PLT Health Solutions, the objective of the study design was to set new standards for communicating efficacy to consumers and regulatory agencies in the weight management category. “In an effort to develop a credible protocol that would truly evaluate Slendacor’s weight management efficacy, we spoke with scientific experts, conducted interviews with industry-leading consumer companies involved in the weight management business, reviewed regulatory positions and also interviewed regulatory groups globally. In response, we created a protocol that investigate the effects of Slendacor supplementation on 140 healthy overweight men and women for 16 weeks – a much larger and longer study than is typically seen for weight management ingredients. During that period, participants consumed two Slendacor tablets before breakfast and lunch, were physically active and ate foods they were used to, just in reduced quantities,” she said. “The results of the study demonstrated significant weight loss, plus significant reductions in waist and hip circumference and decreased BMI., The rigorous design supports efficacy claims for Slendacor that can help build trust with consumers,” she added.
Building Weight Loss Brands Consumers Can Trust
Slendacor Weight Management Complex is a patented, synergistic formulation of three well-known spices – Curcuma longa, Moringa oleifera and Murray koenigii. The combination resulted from screening hundreds of different botanicals to develop synergistic performance supporting weight loss; specifically, the ability to reduce lipogenesis and increase lipolysis was shown by in vitro studies in mouse 3T3 pre-adipocytes (Sengupta et al., 2011). An initial pilot study with obese participants demonstrated weight loss efficacy in humans (Sengupta et al, 2012).
In the most recent study, one hundred and forty participants were randomized into two groups – Slendacor and placebo (n=70/group). At the end of the trial period, the Slendacor- supplemented group showed significant reductions in body weight (5.36±1.769 vs. 0.87±1.381 kg; p<0.0001, Fig 1) and BMI (2.05±0.693 vs. 0.34 ±0.559 kg/m2; p<0.0001), in comparison with the placebo. This represents an average reduction from baseline body weight in the supplemented group of 7.08%, whereas the placebo group lost only 1.16%. Of note is the fact that DEXA analysis showed the body weight reduction in the Slendacor group was due to the loss of fat rather than lean body mass. “As a nutrition scientist, what I liked was to see the consistent, gradual weight loss,” said Dr. Davis, “ultimately, that can help keep the weight off.”
Building a Comprehensive Science Portfolio Around Ingredients
According to Dr. Davis, continuing commitment to conducting robust research with its key ingredients is in line with PLT Health Solutions’ approach to the market. “We are continually working with our partners in evaluating the potential of ingredients and looking for opportunities to make strong, credible claims that address consumer needs. When we see the potential in an ingredient like we saw with Slendacor, we’re willing to invest the resources to further strengthen our scientific support package.,” she said. “We want to help our customers connect with consumers to create trusted brands,” she said.
The study is available via the Wiley Online Library at https://onlinelibrary.wiley.com/doi/abs/10.1111/dom.13443.
Headquartered in Morristown, NJ, USA, PLT Health Solutions is a trusted discoverer, developer, and marketer of high-quality, scientifically-supported ingredients that enhance health and functionality. As a leading ingredients innovator, PLT’s global network of strategic partnerships provides unique access to impactful solutions. By delivering an unsurpassed mix of expertise, resources, and service, PLT is committed to helping both its strategic partners and valued customers grow.