Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355544
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-28
Brief Title:
Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk
Sponsor:
Integrative Phenomics
Organization:
Integrative Phenomics
Study Overview
Official Title:
Integrative and Personalized Lifestyle Approach to Reduce Low-Grade Inflammation in People at Risk of Cardiometabolic Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PINEAPPL
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02494-41 | OTHER | Agence nationale de sécurité du médicament et des produits de santé | None |