Evaluation of D-limonene effects on postprandial intermediary metabolism using "dry blood spots" as a sampling tool in a clinical study carried out remotely

• Grant number: 21/08657-5
• Support Opportunities: Regular Research Grants
• Start date: August 01, 2022
• End date: March 31, 2023
• Field of knowledge: Biological Sciences - Biochemistry - Metabolism and Bioenergetics
• Principal Investigator: Jarlei Fiamoncini
• Grantee: Jarlei Fiamoncini
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Carlos Mario Donado Pestana ; Graziela Biude Silva Duarte ; Karsten Hiller

Abstract

We propose the execution of a clinical study conducted remotely, with minimally invasive, low-cost blood sampling techniques, whose execution is compatible with the limitations imposed by the COVID-19 pandemic. This study will serve as proof of feasibility of a remote clinical trial and will have as its central objective the investigation of the effects of D-limonene on postprandial intermediary metabolism. D-limonene is a citrus industry by-product whose functional properties have already been demonstrated in different experimental models. The effects of D-limonene supplementation on postprandial intermediary metabolism will be assessed by performing a dietary challenge performed before and after the supplementation period, when blood and urine samples will be collected at regular time intervals. The protocol will be carried out in the homes of the research subjects, under the supervision of research agents recruited from the FCF USP community. Blood sampling will be performed by a minimally invasive method, in the form of a dry blood spot (DBS). DBS and urine from research subjects (100 subjects of both sexes) will be analyzed by different metabolomics and lipidomics platforms to investigate the intermediary metabolism and metabolite profile of D-limonene during the postprandial period. This proposal aims to adopt a model for clinical trials or screening tests conducted remotely, as an alternative to the limitations imposed by the COVID-19 pandemic. This study will be a pioneer in the evaluation of the functional effects of D-limonene with a representative number of participants, which will allow the identification of metabotypes by the joint analyzes of metabolomics and lipidomics during the postprandial period. (AU)