Salmon Intake and Gut Health in Adults

Inflammation Clinical Trial

Official title:

Salmon Intake and Gut Health in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792216
• Other study ID #: 20-1033
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: March 2023

Study information

• Verified date: August 2022
• Source: University of Colorado, Denver
• Contact: Minghua Tang, PhD
• Phone: 303-724-3248
• Email: minghua.tang[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Males and non-pregnant, non-lactating pre-menopausal females

• BMI 30-40 kg/m2

• Fasting blood glucose (without blood glucose-lowering drug) between 100-125 mg/dL

• Plasma total cholesterol = 250 mg/dL, plasma triglyceride level = 250 mg/Dl

• Age 30-50 years

• Weight stable over the last 3 months (< 2% body weight change)

• Sedentary and stable physical activity regimen 3 months prior (=3 h/wk of moderate or high intensity exercise, resistance or aerobic training)

• Medication use stable for 6 months prior, and not include anti-inflammatory drugs (e.g. ibuprofen, aspirin)

• Not taking a carotenoid-containing or metabolism-altering supplement for the last 1 month, or have autoimmune diseases, and other malabsorptive disorders (including Crohn's, ileus or ulcerative colitis), liver or kidney insufficiency, allergies to tomatoes

• No current special diets or nutrient supplements, pre- or probiotics (~3 months)

• No tobacco smoking

• Limited consumption of alcoholic beverages = 1/d

• No frequent habitual consumption of salmon or other astaxanthin-rich foods.

Exclusion Criteria:

• Pregnant, lactating, or menopausal females

• BMI < 30 or >40 kg/m2

• Fasting blood glucose <100 or >125 mg/dL; or taking blood glucose lowering medication

• Plasma total cholesterol >250 mg/dL, plasma triglyceride level >250 mg/Dl

• Age <30 or >50 years

• 2% body weight change over the last 3 months

• >3 h/wk of moderate or high intensity exercise, resistance or aerobic training for the 3 months prior

• Changing medications in the past 6 months

• Taking anti-inflammatory drugs (e.g. ibuprofen, aspirin), carotenoid-containing or metabolism-altering supplements (for the last 1 month), or have autoimmune diseases, and other malabsorptive disorders (including Crohn's, ileus or ulcerative colitis), liver or kidney insufficiency, or allergies to tomatoes

• Currently on a special diet or taking nutrient supplements, pre- or probiotics (~3 months)

• Tobacco smoking

• >1/d consumption of alcoholic beverages

• Frequent habitual consumption of salmon or other astaxanthin-rich foods.

Related Conditions & MeSH terms

• Gut Microbiome
• Inflammation

Intervention

Other:
• Wild Salmon
Wild salmon fillets
• Farmed Salmon
Farm salmon fillets

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood biomarkers/inflammatory cytokines	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-1ß, IL-6, IL-10, TNF-a, and MCP-1) will be confirmed by traditional ELISA	Over 32 weeks
Primary	Gut Microbiome	Gut microbiota structure by 16S sequencing	Over 32 weeks
Primary	Fecal metabolomics	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	Over 32 weeks
Secondary	Urine Analysis	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	Over 32 weeks