Salmon Intake and Gut Health in Adults

NCT ID: NCT04792216

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-04-30

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.

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 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.

Conditions

Gut Microbiome; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Wild Salmon

Wild salmon fillets in a raw form

Group Type: EXPERIMENTAL

Wild Salmon

Intervention Type: OTHER

Wild salmon fillets

Farmed Salmon

Farmed salmon fillets in a raw form

Group Type: EXPERIMENTAL

Farmed Salmon

Intervention Type: OTHER

Farm salmon fillets

Interventions

Wild Salmon

Wild salmon fillets

Intervention Type: OTHER

Farmed Salmon

Farm salmon fillets

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

20-1033

Identifier Type: -

Identifier Source: org_study_id