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Salmon Intake and Gut Health in Adults

Primary Purpose

Gut Microbiome, Inflammation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wild Salmon

Farmed Salmon

About this trial

This is an interventional basic science trial for Gut Microbiome

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Wild Salmon

Farmed Salmon

Arm Description

Wild salmon fillets in a raw form

Farmed salmon fillets in a raw form

Outcomes

Primary Outcome Measures

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

Gut Microbiome

Gut microbiota structure by 16S sequencing

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04792216

First Posted

March 8, 2021

Last Updated

August 9, 2022

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT04792216

Brief Title

Salmon Intake and Gut Health in Adults

Official Title

Salmon Intake and Gut Health in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gut Microbiome, Inflammation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Wild Salmon

Arm Type

Experimental

Arm Description

Wild salmon fillets in a raw form

Arm Title

Farmed Salmon

Arm Type

Experimental

Arm Description

Farmed salmon fillets in a raw form

Intervention Type

Other

Intervention Name(s)

Wild Salmon

Intervention Description

Wild salmon fillets

Intervention Type

Other

Intervention Name(s)

Farmed Salmon

Intervention Description

Farm salmon fillets

Primary Outcome Measure Information:

Title

Blood biomarkers/inflammatory cytokines

Description

Time Frame

Over 32 weeks

Title

Gut Microbiome

Description

Gut microbiota structure by 16S sequencing

Time Frame

Over 32 weeks

Title

Fecal metabolomics

Description

Time Frame

Over 32 weeks

Secondary Outcome Measure Information:

Title

Urine Analysis

Description

Time Frame

Over 32 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Minghua Tang, PhD

Phone

303-724-3248

minghua.tang@cuanschutz.edu

Facility Information:

Facility Name

University of Colorado Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Minghua Tang, PhD

Phone

303-724-3248

minghua.tang@ucdenver.edu

First Name & Middle Initial & Last Name & Degree

Minghua Tang, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Salmon Intake and Gut Health in Adults

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