Status:
COMPLETED
Salmon Intake and Gut Health in Adults
Lead Sponsor:
University of Colorado, Denver
Conditions:
Gut Microbiome
Inflammation
Eligibility:
All Genders
30-50 years
Phase:
NA
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 pred...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04792216
Start Date
August 1 2021
End Date
April 30 2023
Last Update
November 19 2024
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045