During the COVID-19 pandemic, Vedic Lifesciences, a contract research organisation (CRO), reports increased interest from dietary supplement companies in the of weight management and sports nutrition categories.
In September 2020, the company 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. Recruitment of volunteers hit a speed bump, the company says, owing to the pandemic, but Vedic sites in India continued enrolling from March to September, completing 88 subjects. The trial sponsor, a US-based dietary ingredient supplier, has consistently used Vedic’s clinical research services and will soon be publishing the results of the study.
Director of Clinical Development, Shalini Srivastava, spoke about a second weight management study, currently enrolling about 144 volunteers during the second wave of the pandemic in India. “During the current lockdown, participants are hesitant to visit the clinical sites. To adapt, we have arranged for doubly sanitised 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.
The 12-week study is measuring a multifactorial suite of outcomes, including body mass index (BMI), fat-free mass and body fat, central obesity, blood-based coronary risk factors, whole body insulin resistance, and markers of inflammation, and satiety by a research-validated questionnaire.
Jayesh Chaudhary, CEO of Vedic offered: “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. 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 faecal 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.”
The company has also been engaged to undertake a rational screening project to identify low glycaemic index actives for foods and supplements. The sponsor wants to screen for endpoints such as satiety, “energy,” and post-meal slump, using validated questionnaires.