Salmon Intake and Gut Health in Adults
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
🗓️ Study Start (Actual) 1 August 2021
🗓️ Primary Completion (Estimated) March 2023
✅ Study Completion (Estimated) March 2023
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 30 Years to 50 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 March 2021
  • First Submitted that Met QC Criteria 8 March 2021
  • First Posted 10 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 August 2022
  • Last Update Posted 11 August 2022
  • Last Verified August 2022