Ignite Creation Date:
2024-05-06 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03322449
Status:
TERMINATED
Last Update Posted:
2021-04-19
First Post:
2017-09-08
Brief Title:
APOA2 Gene Diet Inflammation and Gut Health
Sponsor:
Tufts University
Organization:
Tufts University
Study Overview
Official Title:
APOA2 Gene Diet Inflammation and Gut Health
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nutrients and chemicals in food are able to regulate expression of genetic elements Gene-nutrient interaction in response to unhealthy diets can increase an individuals risk shifting the individual from health toward the development of chronic disease The apolipoprotein A2 APOA2 gene may either put individuals at risk for or protect from obesity in the presence of certain fats in food The main purpose of this four-week study is to examine diet induced gene-nutrient interaction with a focus on gut health gut microbiota and inflammation in individuals who have either the CC or the TT form within a specific variant of the APOA2 Gene The 2 one-week study diets one plant based and the other animal based are separated by a 1 week return to your regular habitual without probiotic or prebiotic food products
Detailed Description:
The primary objectives of this application are 1 To use a diet intervention setting to rigorously evaluate the mechanisms responsible for the previously observed effects focusing on gut microbiota and markers of gut health and inflammation and 2 To prove that targeted dietary intervention based on genes can provide additional tailored benefit to genetically vulnerable individuals The overall hypothesis proposes that significant cross-talk between the human host genome the microbiome and the diet defines the observed inter-individual variation in metabolic and physiological responses Accordingly the investigators propose the following specific aims and hypotheses
AIM 1 To catalog the response of the plasma metabolome to diets differing in saturated fat and prebiotics content animal-based diet versus plant-based diet in individuals from the USA carrying CC n20 and TT n20 genotypes at the common APOA2 -265TC SNP using a crossover randomized dietary intervention study
Our primary hypothesis states A significant and biologically relevant proportion of the individual variation in changes in the plasma metabolome in response to dietary saturated fat and prebiotic intake will be due to APOA2-265TC genotypes Specifically subjects homozygous CC for the less common C allele will respond to decreases in total dietary saturated fat and increases in prebiotics ie plant-based diet with significantly greater improvement of metabolites related to gut health inflammation and other cardiometabolic traits than subjects homozygous TT for the common T allele
AIM 2 To characterize differential impacts of low SFAhigh prebiotic plant-based diet vs high SFAlow prebiotic animal-based diets on gut microbiota patterns between CC and TT persons at APOA2-265TC
Our primary hypothesis states CC subjects have a preference for high-fat and -protein foods and therefore high levels of Bacteroidetes Actinobacteria and similar species in the gut are expected Moreover reducing intake of saturated fat and increasing prebiotics will be more effective in inducing a healthier gut microflora profile in CC subjects than in those with the TT genotype with opposite effects observed when the diet is switched to one high in saturated fat
AIM 3 To integrate the metabolomic and gut microflora taxonomic information generated in AIM1 and AIM2 in order to elucidate the physiological mechanisms by which diet impinges on metabolic pathways through APOA2 genotypes
Our primary hypothesis states A diet low in saturated fat and high in prebiotics induces beneficial changes in gut microbiota metabolic processes and inflammation which are significantly more pronounced in CC than in TT subjects
AIM 1 To catalog the response of the plasma metabolome to diets differing in saturated fat and prebiotics content animal-based diet versus plant-based diet in individuals from the USA carrying CC n20 and TT n20 genotypes at the common APOA2 -265TC SNP using a crossover randomized dietary intervention study
Our primary hypothesis states A significant and biologically relevant proportion of the individual variation in changes in the plasma metabolome in response to dietary saturated fat and prebiotic intake will be due to APOA2-265TC genotypes Specifically subjects homozygous CC for the less common C allele will respond to decreases in total dietary saturated fat and increases in prebiotics ie plant-based diet with significantly greater improvement of metabolites related to gut health inflammation and other cardiometabolic traits than subjects homozygous TT for the common T allele
AIM 2 To characterize differential impacts of low SFAhigh prebiotic plant-based diet vs high SFAlow prebiotic animal-based diets on gut microbiota patterns between CC and TT persons at APOA2-265TC
Our primary hypothesis states CC subjects have a preference for high-fat and -protein foods and therefore high levels of Bacteroidetes Actinobacteria and similar species in the gut are expected Moreover reducing intake of saturated fat and increasing prebiotics will be more effective in inducing a healthier gut microflora profile in CC subjects than in those with the TT genotype with opposite effects observed when the diet is switched to one high in saturated fat
AIM 3 To integrate the metabolomic and gut microflora taxonomic information generated in AIM1 and AIM2 in order to elucidate the physiological mechanisms by which diet impinges on metabolic pathways through APOA2 genotypes
Our primary hypothesis states A diet low in saturated fat and high in prebiotics induces beneficial changes in gut microbiota metabolic processes and inflammation which are significantly more pronounced in CC than in TT subjects
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