Globally, clinical research over the past year-and-a-half has been presented with logistical challenges due to the COVID-19 pandemic, some of which caused researchers to pull the brakes on certain types of trials. Vedic Lifesciences, an India-based contract research organization reported that they’ve had to match an increased interest from dietary supplement companies in weight management and sports nutrition companies.
 
Vedic Lifesciences reports that in September 2020, it concluded a multi-national study evaluating the impact of a botanical supplement on body composition, as well as metabolic and hormonal factors, in overweight and obese individuals.
 
They report that recruitment of new volunteers “hit a speed bump” at the outbreak of COVID-19, the company said. One site in the U.S. had to be stopped due to unrelated reasons, however, Vedic sites in India continued enrolling from March-September, and so far, 88 subjects have completed the trial period. The trial sponsor, a U.S. based dietary ingredient supplier, has been consistently using Vedic’s clinical research services, the company reports, and that favorable results in this study will be published soon.
 
Vedic Sciences is enrolling about 144 volunteers for a second weight management study despite the current second wave of the pandemic India is currently experiencing. “During the lockdown, participants are hesitant to visit the clinical sites. To adapt, we have arranged for doubly sanitized cab services to the research site, and home visits by masked phlebotomists, to make life easier for the study participants as well as our project managers. This is maintaining the pace of recruitment,” she said.
 
This present 12-week study is measuring multiple outcomes including BMI, fat-free mass, body fat, central obesity, blood-based coronary risk factors, whole body insulin resistance, markers of inflammation, and satiety by a research-validated questionnaire.
 
“Client interest in sponsoring sports studies with us for claims related to weight management, body composition, and muscular endurance and strength is not a new trend,” Jayesh Chaudhary, CEO of Vedic, said. “We did our first weight loss study in 2005. What is heartening is the interest of sponsors integrating cutting-edge surrogate biomarkers such as ghrelin, adiponectin, and leptin, and genomic tools such as 16S microbiome analysis of fecal samples. Along with our excellent research partners here and globally, we will continue to serve the global dietary supplement industry, striving to impart the most value to their products, at a speed, transparency, and cost that is unparalleled.”
 
Vedic Lifesciences is also engaged in a novel project to screen low glycemic index actives for foods and supplements. The sponsor is also seeking to screen for endpoints such as satiety, energy, and post-meal slump, using questionnaires validated by previous research.
 
The company will continue to specialize in helping dietary supplement and ingredient companies with clinical trials, preclinical and toxicity studies for GRAS and NDI notifications, as they have since 2000.