University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
NCT Number: NCT04792216
The overall objective of this project is to determine the interplay of salmon as a whole food and its bioactive compound astaxanthin on gut microbiome, fecal metabolome, and inflammation in obese prediabetic individuals. Our central hypothesis is that dietary bioactive astaxanthin in the form of whole food salmon will effectively reduce inflammation in obese prediabetic individuals, and favorably change the gut microbiota composition and diversity. The investigators anticipate that these changes will result in improved metabolic outcomes in obesity and type 2 diabetes.
The two primary aims include:
Aim 1: Assess the anti-inflammatory effect of the salmon dietary intervention and the underlying mechanisms on the change in plasma levels of inflammatory cytokines important for the host immune response.
Aim 2: Identify whether the relationship between salmon consumption and decreased inflammation is mediated by the gut microbiome.
Looking for future studies?
Notify Me30 year–50 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
The goal of this project is to determine whether increased intake of salmon as a whole food and its bioactive compound astaxanthin has a causal impact on preventing inflammation by promoting human gut microbiome homeostasis. Findings from this study will provide new insights into maintenance of gut microbiome and will inform effective dietary recommendations and interventions, thereby reducing inflammation-associated diseases in humans.
Aim: Evaluate the anti-inflammatory properties of astaxanthin-enriched salmon via re-balancing of human gut microbiome in obese prediabetic human subjects.
The investigators will use a randomized, double-blind, crossover feeding study with 15 obese prediabetic males and 15 obese prediabetic females (n=30) . Participants will consume two servings (3 oz per serving) of wild salmon (intervention 1) and farmed salmon (intervention 2) daily in random orders. Each intervention is 4 weeks long and the washout duration between the two interventions is 5 weeks. Primary outcomes will be determined by measuring the inflammatory response and gut microbiota composition.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Wild salmon fillets
Farm salmon fillets
Time frame: Over 32 weeks
Blood from patients will be processed via centrifugation to archive plasma. A panel of 48 factors from Bio-Rad (Bio-Plex Pro™ Human Cytokine Screening Panel, 48-Plex #12007283) will be measured in plasma by Bio-Rad Bio-Plex analyzer. Five primary biomarkers (IL-1β, IL-6, IL-10, TNF-α, and MCP-1) will be confirmed by traditional ELISA
Time frame: Over 32 weeks
Gut microbiota structure by 16S sequencing
Time frame: Over 32 weeks
Small molecules will be extracted using MTBE-based liquid:liquid extraction which results in lipid and aqueous fractions. Compounds will be "extracted" using commercial software (Mass Hunter, Agilent), quantitated using peak volumes and processed using Mass Profiler Professional (MPP, Agilent) to determine normalized compound intensities
Time frame: Over 32 weeks
Urine samples will be collected for future metabolomics analysis. This analysis will generate a metabolomics profile in biospecimens, which will help us identify potential signatures related to salmon intake
University of Colorado, Denver
Other
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