Salmon Intake and Gut Health in Adults

NCT04792216 | Completed

• 1 other identifier: 20-1033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiome; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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-1β, IL-6, IL-10, TNF-α, and MCP-1) will be confirmed by traditional ELISA

  Over 32 weeks

• Gut Microbiome

  Gut microbiota structure by 16S sequencing

  Over 32 weeks

• 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 Outcomes (1)

• Urine Analysis

  Over 32 weeks

Study Arms (2)

Wild Salmon

EXPERIMENTAL

Wild salmon fillets in a raw form

Other: Wild Salmon

Farmed Salmon

EXPERIMENTAL

Farmed salmon fillets in a raw form

Other: Farmed Salmon

Interventions

Wild Salmon OTHER

Wild salmon fillets

Wild Salmon

Farmed Salmon OTHER

Farm salmon fillets

Farmed Salmon

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• % 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 10, 2021
• Study Start: August 1, 2021
• Primary Completion: April 3, 2023
• Study Completion: April 30, 2023
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)