Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk — PINEAPPL  

Healthy Clinical Trial

Official title: Integrative and Personalized Lifestyle Approach to Reduce Low-Grade Inflammation in People at Risk of Cardiometabolic Diseases

Status Not yet recruiting

Clinical Trial Summary

The goal of this observational study is to learn about low-grade inflammation in healthy individuals and individuals with overweight or obesity.

The main questions it aims to answer are:

• Whether it is possible to predict low-grade inflammation

• What are the medical, biological, and lifestyle variables related to low-grade inflammation?

Participants will be asked to:

1. Attend a general medical visit to collect vital signs, anthropometric measurements, and collect blood samples.

2. Complete questionnaires and collect a stool sample at home.

Clinical Trial Description

Cardiometabolic diseases (CMDs) are a heterogeneous spectrum of nutrition-related chronic diseases, ranging from obesity to diabetes and, ultimately, to acute and chronic cardiovascular diseases. Once established, these diseases are usually irreversible and evolve over time. Since these diseases are born out of societal and lifestyle changes, the cornerstones of prevention and management are changes in nutrition and lifestyle. This inevitable increase in CMDs, including obesity, particularly affects socially vulnerable populations.

The etiology of cardiometabolic diseases is complex and involves environmental, biological and genetic elements. Weight gain is at the heart of these pathologies: it frequently precedes their development or contributes to the progression of these diseases. To this end, even modest weight loss is suggested as an important line of prevention or treatment of cardiometabolic diseases. For example, diabetes remission can be achieved with weight loss and is directly correlated with the amount of weight lost. Despite the beneficial effects of weight loss on preventing the progression of cardiometabolic diseases, maintaining weight loss is difficult, with only 30% of individuals achieving long-term weight loss (5 years). The same is true with the development of anti-obesity treatments (new analogues of glucagon-like peptide 1 (GLP1)); Discontinuation of treatment is accompanied by weight gain. In the case of diabetes, weight gain is associated with the recurrence of previously remitted diabetes.

Chronic low-grade inflammation is tightly linked with obesity and a central feature of cardiometabolic diseases and associated diseases. Furthermore, it paves the way for future comorbidities. This inflammation is characterized by a rise of systemic or circulating inflammatory molecules. However, no single cytokine can reflect the inflammatory state seen in cardiometabolic diseases and these systemic factors are highly variable from subject to subject. Recently, combinatorial indexes, using multiple inflammatory markers have been strongly associated with coronary risks and Metabolic alterations.

Over the past 10 years, the gut microbiome has become a recognized contributor to our metabolic health. Accumulating evidence has shown that the gut microbiome strongly reflects environmental and lifestyle changes (including nutrition) by altering its diversity and composition as well as its functions by producing molecules that interact with host organs, including the brain. The excess or deficit production of molecules produced by the microbiota, bacterial metabolites (such as trimethylamine oxide (TMAO), Imidazole propionate, branched-chain amino acids (BCAAs), or short-chain fatty acids (SCFAs), etc.) are molecules implicated in the link between the environment, microbiota and metabolic and inflammatory disturbances.

Current strong evidence indicates that the gut microbiota is altered early in people with inflammatory diseases that include CMDs. Relationships between the inflammatory component of the diet and the gut microbiome have also been identified.

In an effort to predict chronic-low grade inflammation in a real-world population and decipher the relationships between chronic low-grade inflammation and individual factors, comprising lifestyle, diet, behavior, environment, the gut microbiome, and health-related clinical data, the present study recruits a cohort of participants across age, sex, body mass index, and metabolic health spectra. Chronic low-grade inflammation markers of interest will be measured to establish a multi-component index of inflammation relative in the population. ;

Related Conditions & MeSH terms

• Abdominal Obesity
• Healthy
• Hypercholesterolemia
• Hypertension
• Inflammation
• Low-grade Inflammation
• Metabolic Syndrome
• Metabolically Healthy Controls
• Normal Weight Adults
• Obesity
• Obesity, Abdominal
• Overweight
• Risk Factor, Cardiovascular

• NCT number: NCT06355544
• Study type: Observational
• Source: Integrative Phenomics
• Contact: Karine Clément, MD, PhD
• Phone: 33142177031
• Email: karine.clement@aphp.fr
• Status: Not yet recruiting
• Start date: April 2024
• Completion date: June 30, 2026