Gut MicrobiomeNCT04792216
Salmon Intake and Gut Health in Adults
A study testing Wild Salmon and Farmed Salmon in people with Gut Microbiome and Inflammation, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Gut Microbiome, Inflammation
- What is being tested?
- Wild Salmon and Farmed Salmon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- >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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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:
Read more
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.
Read the 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
- Being tested
- Wild Salmon, Farmed Salmon
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wild SalmonOther
Wild salmon fillets
Farmed SalmonOther
Farm salmon fillets
| Study group | Role | What they receive |
|---|---|---|
| Wild Salmon | Experimental | Wild salmon fillets in a raw form Receives: Other: Wild Salmon |
| Farmed Salmon | Experimental | Farmed salmon fillets in a raw form Receives: Other: Farmed Salmon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Over 32 weeks
Gut Microbiome
Gut microbiota structure by 16S sequencing
Measured: 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
Measured: Over 32 weeks
Secondary outcomes (1)
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
Measured: Over 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Aug 2021
- Primary completion3 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792216
- Sponsor's protocol ID
- 20-1033
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2021
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salmon Intake and Gut Health in Adults
- ClinicalTrials.gov ID
- NCT04792216
- Acronym / sponsor ID
- 20-1033
- Conditions
- Gut Microbiome, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wild Salmon | Experimental | Other: Wild SalmonWild salmon fillets in a raw form |
| Farmed Salmon | Experimental | Other: Farmed SalmonFarmed salmon fillets in a raw form |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wild SalmonWild salmon fillets | Other | Wild Salmon |
| Farmed SalmonFarm salmon fillets | Other | Farmed Salmon |
Primary outcome
Blood biomarkers/inflammatory cytokines
Time frame: Over 32 weeks
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
Time frame: Over 32 weeks
Gut microbiota structure by 16S sequencing
Fecal metabolomics
Time frame: Over 32 weeks
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
1 secondary outcome
Urine Analysis
Time frame: Over 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wild Salmon and Farmed Salmon in people with Gut Microbiome and Inflammation, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood biomarkers/inflammatory cytokines (time frame: Over 32 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.