An interventional study of Animal Diet and Plant Diet in Inflammation, sponsored by Tufts University. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Tufts University · Not applicable, Interventional, and Prevention
Nutrients and chemicals in food are able to regulate expression of genetic elements. Gene-nutrient interaction in response to unhealthy diets can increase an individual's 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.
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 (n=20) and TT (n=20) genotypes at the common APOA2 -265T>C 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 APOA2-265T>C genotypes. Specifically, subjects homozygous (CC) for the less common C allele will respond to decreases in total dietary saturated fat and increases in prebiotics (i.e., 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 SFA/high prebiotic (plant-based) diet vs. high SFA/low prebiotic (animal-based) diets on gut microbiota patterns between CC and TT persons at APOA2-265T>C.
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 mechanism(s) 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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 2,577 interventional studies indexed under Inflammation.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
during this Arm, the participants will receive a diet enriched in animal products
Other: Animal Diet
during this Arm, the participants will receive a diet enriched in plant products
Other: Plant Diet
during one week participants will receive food products enriched in animal products and with high content of fat and protein
during one week participants will receive plant products enriched in fiber and complex carbohydrates
tryptophan metabolism
The response of plasma metabolites related to tryptophan metabolism to diets differing in saturated fat and prebiotics content (animal-based diet versus plant-based diet) will vary in individuals carrying CC (n=20) and TT (n=20) genotypes at the common APOA2 -265T\>C single nucleotide polymorphism (SNP)
Time frame: 1 week per intervention arm
Satiety assessment using plasma levels of leptin
Plasma leptin (ng/ml) will be measured in plasma during each one of the intervention phases. The response of leptin (ng/ml) to a saturated fat rich diet will be less on subjects with the CC genotype at the APOA2 locus as compared to TT subjects
Time frame: 1 week per intervention arm
adipose tissue metabolism
Plasma adiponectin (micrograms/ml) will be measured in plasma during each one of the intervention phases. The response of adiponectin to a saturated fat rich diet will be less on subjects with the CC genotype at the APOA2 locus as compared to TT subjects
Time frame: 1 week per intervention arm
Plasma Lipoproteins
Plasma lipoprotein concentrations in mg/dl (VLDL, LDL, HDL) and subclasses assessed by proton nuclear magnetic resonance (NMR) spectroscopy
Time frame: 1 week per intervention arm
Gut microbiota diversity and composition
A low saturated fat (SFA)/high prebiotic (plant-based) diet and a high SFA/low prebiotic (animal-based) diets have a differential effect on gut microbiota patterns according to the presence of the CC or TT genotypes at the APOA2-265T\>C variant
Time frame: 1 week per intervention arm
Plasma levels of Interleukin 6 to assess inflammatory status
Plasma Levels of interleukin-6 (IL6) (pg/ml) will be measured during each of the dietary phases. IL6 will be higher in CC subjects at the APOA2 locus when consuming a high fat diet than when consuming a low fat diet. A low fat diet will not elicit increased IL6 levels in TT APOA2 subjects.
Time frame: 1 week per intervention arm
Plasma levels of tumor necrosis factor alpha to assess regulation of immune cells
Plasma Levels of tumor necrosis factor alpha (TNFA)(pg/ml) measured during each diet phase, will be significantly different depending on diet and APOA2 genotype. TNFA will be higher in CC subjects at the APOA2 locus when consuming a high fat diet than when consuming a low fat diet. A low fat diet will not elicit increased TNFA levels in TT APOA2 subjects.
Time frame: 1 week per intervention arm
Plasma levels of C-reactive to assess regulation of inflammation
Plasma Levels of C-reactive protein (CRP) (mg/L) measured during each diet phase will be significantly different depending on diet and APOA2 genotype. CRP will be higher in CC subjects at the APOA2 locus when consuming a high fat diet than when consuming a low fat diet. A low fat diet will not elicit increased CRP levels in TT APOA2 subjects.
Time frame: 1 week per intervention arm
Plasma levels of Lipopolysaccharides to assess gut inflammation
Plasma Levels of lipopolysaccharides (LPS) (ng/ml) will be significantly different depending on diet and APOA2 genotype. LPS will be higher in CC subjects at the APOA2 locus when consuming a high fat diet than when consuming a low fat diet. A low fat diet will not elicit increased LPS levels in TT APOA2 subjects.
Time frame: 1 week per intervention arm
Plan to share: No
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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