Dietary HabitsMini-MEDNCT05500976
Metabolomics Initiative: Mediterranean-amplified vs Habitual Western Diet on Food Signatures, Health, and Microbiome
A study of Dietary Habits, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about how consuming a diet with foods typical to a Mediterranean Diet such as whole grains, fruits and vegetables in a Western-style diet compares to eating a typical Western-style diet. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Dietary Habits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2022to 31 Mar 2025
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obesity (BMI 25-37 kg/m2) and weight-stable;
- Age 30-69 years;
- Nonsmoker (including tobacco, marijuana, and other inhaled substances);
- Consistent physical activity levels for 3 months prior to and throughout the study period;
- Stable medication use for 6 months prior to and throughout the study period;
- Having at least three components of Metabolic Syndrome (MetS): i.e., impaired fasting glucose, hypertension, central adiposity (waist circumference ≥ 94 cm or 80 cm, for men and women, respectively), fasting hypertriglyceridemia, and/or low levels of HDL cholesterol17 OR on medication for the treatment of hyperglycemia, hypertension, or hypercholesterolemia in lieu of meeting the corresponding MetS component;
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- Report of baseline consumption of a habitual diet not meeting criteria for a Mediterranean-style dietary pattern, defined as a score of <5 as assessed via the Mediterranean Diet Assessment Tool
- Follows an omnivorous diet and willing to consume all provided foods (e.g., will eat salmon, fruits/vegetables, beef);
- Willingness to refrain from consumption of nutritional supplements, herbal supplements, botanical supplements, and pre- or probiotics aside from those prescribed by a physician for the duration of the study;
- Willingness to come to the CTRC biweekly for clinical assessments and biospecimen collection;
- No plans to relocate or for extended travel (>1 week) within next 6 months; and
- Capable and willing to provide informed consent
Who cannot join
- Use of medications contraindicating increased consumption of fruits/vegetables (e.g., warfarin);
- Diagnosis of acute or chronic condition impacting appetite, food intake, and/or the metabolism and absorption of foods to be provided (e.g., Crohn's disease, Celiac disease, Ulcerative colitis, short bowel syndrome, chronic diarrhea);
- Impaired liver or kidney function;
- Food allergies to foods provided in either dietary intervention;
- Vegetarian, vegan; and
- For females: pregnant or lactating or planning to become pregnant during study period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
Official title: Metabolomics INItiative: Effects of a MEDiterranean-amplified vs Habitual Western Diet on Biomarker Signatures, Cardiometabolic Health, and the Microbiome
This study plans to learn more about how consuming a diet with foods typical to a Mediterranean Diet such as whole grains, fruits and vegetables in a Western-style diet compares to eating a typical Western-style diet. This study will look at how diet affects overall health including risk factors for heart disease, gut health and inflammation as well as underlying mechanisms linking whole food to health. Findings from this study will potentially inform effective dietary recommendations and interventions, thereby reducing chronic disease in humans.
Read the detailed description
The investigators propose to conduct a 16-week randomized, cross-over, semi-controlled feeding study of two isocaloric dietary interventions: 1. Mediterranean-amplified habitual/Western (mini-MED) diet, containing 500 kcal/day from Mediterranean target foods (such as raspberries, avocado, red bell pepper, basil, walnuts, chickpeas, oats, salmon); and 2. Habitual/Western (Western) diet, containing 500 kcal/day from non-Mediterranean target foods (such as potato, beef, sour cream, refined grain bread, chocolate dessert); among individuals who are not already consuming a Mediterranean-style dietary pattern. Participants will have overweight or obesity and meet criteria for Metabolic Syndrome (MetS), and therefore be at increased risk of cardiometabolic disease (CMD).
The primary goal is to validate results from metabolomics analyses of foods and biospecimens from a completed Mediterranean-style dietary intervention in a prospective feeding trial. Secondary aims are to evaluate impacts of incremental changes in diet on cardiometabolic health and microbiome structure/function. The primary hypothesis is that pre-defined metabolomics signatures in participant biospecimens will be responsive to dietary intakes and reproducible within individuals over time. The secondary hypotheses are that a Mediterranean-amplified diet will lead to improvements in cardiometabolic health and changes in microbiome structure/function over time and compared to a habitual Western diet.
Aim 1: Test reproducibility of pre-defined signatures from Mediterranean target foods provided in mini-MED in biospecimens (blood/urine) within individuals over time. Participants will complete a 16-week randomized cross-over dietary intervention of mini-MED vs Western diet. The investigators hypothesize that: (1) novel food-specific compounds will increase in participant biospecimens after consumption of mini-MED and decrease during Western diet, and (2) established biomarkers of fruit/vegetable intake (e.g., plasma and skin carotenoids, urine polyphenols) and other target foods (e.g., plasma alkylresorcinols, astaxanthin) will increase after consumption of mini-MED.
Aim 2: Determine the impact of mini-MED on cardiometabolic health. Cardiometabolic health indicators (e.g., blood pressure, lipid panel, inflammatory cytokines, indicators of subclinical inflammation) will be assessed pre- and post- each intervention. The investigators hypothesize that consumption of mini-MED will lead to improvements in cardiometabolic health indicators (e.g., reductions in blood pressure, total cholesterol, LDL cholesterol, triglycerides, C-reactive protein, bioactive lipids; increases in HDL cholesterol) over time and compared to Western diet.
Aim 3: Evaluate changes in microbiota community structure/function in response to mini-MED. Microbiome structure (taxonomy) and function (metagenomics) will be assessed pre- and post- each intervention. The investigators hypothesize that consumption of mini-MED will lead to increases in microbiome diversity and enrichment in taxa associated with increased production of health-promoting compounds (e.g., short chain fatty acids) over time and compared to Western diet.
- Conditions
- Dietary Habits
- Being tested
- Semi-controlled dietary intervention - Western, Semi-controlled dietary intervention - MiniMed
- Keywords
- Mediterranean diet, Foodomics, Metabolomics, Food-specific signatures, Cardiometabolic health, Microbiome
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-controlled dietary intervention - WesternOther
Participants will complete a 2-week washout prior to a 16-week randomized, crossover semi-controlled feeding study of mini-MED vs Western diet. Each diet intervention will last four weeks, with 500 kcal/day of target Western diet foods (eg, beef, potatoes, bread, sour cream) provided during each intervention and will be repeated twice.
Semi-controlled dietary intervention - MiniMedOther
Participants will complete a 2-week washout prior to a 16-week randomized, crossover semi-controlled feeding study of mini-MED vs Western diet. Each diet intervention will last four weeks, with 500 kcal/day of target Mediterranean foods (eg, oatmeal, salmon, nuts, basil, olive oil, fruits) provided during each intervention and will be repeated twice.
| Study group | Role | What they receive |
|---|---|---|
| mini-Med | Experimental | Mediterranean-amplified habitual/Western (mini-MED) diet, containing 500 kcal/day from Mediterranean target foods (such as raspberries, avocado, red bell pepper, basil, walnuts, chickpeas, oats, salmon). Receives: Other: Semi-controlled dietary intervention - MiniMed |
| Western | Active comparator | Habitual/Western (Western) diet, containing 500 kcal/day from non-Mediterranean target foods (such as potato, beef, sour cream, refined grain bread, chocolate dessert). Receives: Other: Semi-controlled dietary intervention - Western |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foodomics
Change in the number of unique to food compounds (i.e., putative biomarkers of intake) from baseline to end of each diet intervention period in participant serum samples.
Measured: Baseline to endline changes in food-specific compounds over each 4-week dietary intervention period
Secondary outcomes (13)
Cardiometabolic Health - IL-6
Changes in blood inflammatory markers including IL-6 over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - TNF-alpha
Changes in blood inflammatory markers including TNF-alpha over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - C-reactive protein
Changes in blood inflammatory markers including C-reactive protein over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - alpha-1-acid glycoprotein
Changes in blood inflammatory markers including alpha-1-acid glycoprotein over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Total Cholesterol
Changes in fasting total cholesterol over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - LDL Cholesterol
Changes in fasting LDL cholesterol over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - HDL Cholesterol
Changes in fasting HDL cholesterol over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Triglycerides
Changes in fasting triglycerides over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Blood Pressure
Changes in blood pressure over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Insulin
Changes in fasting blood insulin over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Glucose
Changes in fasting blood glucose over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Adipokines
Changes in circulating plasma adipokines over time and between the two dietary interventions.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Gut Microbiota
Changes in diversity and community composition of the gut microbiota.
Measured: Baseline to endline changes over each 4-week dietary intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start21 Nov 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies 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
- Model description
- Participants will complete a 16-week randomized cross-over semi-controlled feeding study comparing two isocaloric dietary interventions. The two diets will be a Mediterranean-amplified habitual/Western (mini-MED) diet, containing 500 kcal/day from Mediterranean target foods (such as raspberries, avocado, red bell pepper, basil, walnuts, chickpeas, oats, salmon) and their habitual/Western (Western) diet, Participants will be randomized (1:1) to start one of the dietary interventions, with subsequent assignment to the other upon completion of the first. A permuted block randomization scheme using block size of 2 and stratification by sex will be utilized to ensure balance between intervention order and number of males and females in each arm.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cattlemen's Beef Association, a contractor to the Beef Checkoff, Purdue University
- Responsible party
- Sponsor
- Investigators
- Nancy F Krebs, MD, Principal investigator, University of Colorado School of MedicineNichole Reisdorph, PhD, Principal investigator, University of Colorado School of PharmacyWayne Campbell, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500976
- Sponsor's protocol ID
- 21-4563
- Other IDs
- R01DK113957, 2070
- Acronym
- Mini-MED
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1\) Data will be made available in accordance with the "Final NIH Statement on Sharing Research Data". Results, data, workflows, and tools will be made available through publication, presentations at scientific meetings, open access on our website following publication, in open repositories when they are established, and according to other policies set forth by the NIH. The primary type of data collected will be raw mass spectrometry data. There are widely available free-ware data converters for mass spectrometry data that have been created by the mass spectrometry community. Thus, the data from this project will be saved in the original raw format.
Publications
Hill EB, Tang M, Long JM, Kemp JF, Westcott JL, Hendricks AE, Reisdorph NA, Campbell WW, Krebs NF; mini-MED Trial Team. mini-MED: study protocol for a randomized, multi-intervention, semi-controlled feeding trial of a Mediterranean-amplified vs. habitual Western dietary pattern for the evaluation of food-specific compounds and cardiometabolic health. Trials. 2024 Feb 2;25(1):101. doi: 10.1186/s13063-024-07939-8.
PubMed 38302990Hill EB, Reisdorph RM, Rasolofomanana-Rajery S, Michel C, Khajeh-Sharafabadi M, Doenges KA, Weaver N, Quinn K, Sutliff AK, Tang M, Borengasser SJ, Frank DN, O'Connor LE, Campbell WW, Krebs NF, Hendricks AE, Reisdorph NA. Salmon Food-Specific Compounds and Their Metabolites Increase in Human Plasma and Are Associated with Cardiometabolic Health Indicators Following a Mediterranean-Style Diet Intervention. J Nutr. 2024 Jan;154(1):26-40. doi: 10.1016/j.tjnut.2023.10.024. Epub 2023 Oct 31.
PubMed 37918675
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics INItiative: Effects of a MEDiterranean-amplified vs Habitual Western Diet on Biomarker Signatures, Cardiometabolic Health, and the Microbiome
- ClinicalTrials.gov ID
- NCT05500976
- Acronym / sponsor ID
- Mini-MED / 21-4563
- Conditions
- Dietary Habits
- Keywords
- Mediterranean diet, Foodomics, Metabolomics, Food-specific signatures, Cardiometabolic health, Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cattlemen's Beef Association, a contractor to the Beef Checkoff, Purdue University
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 15 Aug 2022 (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.
This study plans to learn more about how consuming a diet with foods typical to a Mediterranean Diet such as whole grains, fruits and vegetables in a Western-style diet compares to eating a typical Western-style diet. This study will look at how diet affects overall health including risk factors for heart disease, gut health and inflammation as well as underlying mechanisms linking whole food to health. Findings from this study will potentially inform effective dietary recommendations and interventions, thereby reducing chronic disease in humans.
Detailed description
The investigators propose to conduct a 16-week randomized, cross-over, semi-controlled feeding study of two isocaloric dietary interventions: 1. Mediterranean-amplified habitual/Western (mini-MED) diet, containing 500 kcal/day from Mediterranean target foods (such as raspberries, avocado, red bell pepper, basil, walnuts, chickpeas, oats, salmon); and 2. Habitual/Western (Western) diet, containing 500 kcal/day from non-Mediterranean target foods (such as potato, beef, sour cream, refined grain bread, chocolate dessert); among individuals who are not already consuming a Mediterranean-style dietary pattern. Participants will have overweight or obesity and meet criteria for Metabolic Syndrome (MetS), and therefore be at increased risk of cardiometabolic disease (CMD).
The primary goal is to validate results from metabolomics analyses of foods and biospecimens from a completed Mediterranean-style dietary intervention in a prospective feeding trial. Secondary aims are to evaluate impacts of incremental changes in diet on cardiometabolic health and microbiome structure/function. The primary hypothesis is that pre-defined metabolomics signatures in participant biospecimens will be responsive to dietary intakes and reproducible within individuals over time. The secondary hypotheses are that a Mediterranean-amplified diet will lead to improvements in cardiometabolic health and changes in microbiome structure/function over time and compared to a habitual Western diet.
Aim 1: Test reproducibility of pre-defined signatures from Mediterranean target foods provided in mini-MED in biospecimens (blood/urine) within individuals over time. Participants will complete a 16-week randomized cross-over dietary intervention of mini-MED vs Western diet. The investigators hypothesize that: (1) novel food-specific compounds will increase in participant biospecimens after consumption of mini-MED and decrease during Western diet, and (2) established biomarkers of fruit/vegetable intake (e.g., plasma and skin carotenoids, urine polyphenols) and other target foods (e.g., plasma alkylresorcinols, astaxanthin) will increase after consumption of mini-MED.
Aim 2: Determine the impact of mini-MED on cardiometabolic health. Cardiometabolic health indicators (e.g., blood pressure, lipid panel, inflammatory cytokines, indicators of subclinical inflammation) will be assessed pre- and post- each intervention. The investigators hypothesize that consumption of mini-MED will lead to improvements in cardiometabolic health indicators (e.g., reductions in blood pressure, total cholesterol, LDL cholesterol, triglycerides, C-reactive protein, bioactive lipids; increases in HDL cholesterol) over time and compared to Western diet.
Aim 3: Evaluate changes in microbiota community structure/function in response to mini-MED. Microbiome structure (taxonomy) and function (metagenomics) will be assessed pre- and post- each intervention. The investigators hypothesize that consumption of mini-MED will lead to increases in microbiome diversity and enrichment in taxa associated with increased production of health-promoting compounds (e.g., short chain fatty acids) over time and compared to Western diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete a 16-week randomized cross-over semi-controlled feeding study comparing two isocaloric dietary interventions. The two diets will be a Mediterranean-amplified habitual/Western (mini-MED) diet, containing 500 kcal/day from Mediterranean target foods (such as raspberries, avocado, red bell pepper, basil, walnuts, chickpeas, oats, salmon) and their habitual/Western (Western) diet, Participants will be randomized (1:1) to start one of the dietary interventions, with subsequent assignment to the other upon completion of the first. A permuted block randomization scheme using block size of 2 and stratification by sex will be utilized to ensure balance between intervention order and number of males and females in each arm.
| Arm | Type | Receives |
|---|---|---|
| mini-Med | Experimental | Other: Semi-controlled dietary intervention - MiniMedMediterranean-amplified habitual/Western (mini-MED) diet, containing 500 kcal/day from Mediterranean target foods (such as raspberries, avocado, red bell pepper, basil, walnuts, chickpeas, oats, salmon). |
| Western | Active comparator | Other: Semi-controlled dietary intervention - WesternHabitual/Western (Western) diet, containing 500 kcal/day from non-Mediterranean target foods (such as potato, beef, sour cream, refined grain bread, chocolate dessert). |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Overweight or obesity (BMI 25-37 kg/m2) and weight-stable;
- Age 30-69 years;
- Nonsmoker (including tobacco, marijuana, and other inhaled substances);
- Consistent physical activity levels for 3 months prior to and throughout the study period;
- Stable medication use for 6 months prior to and throughout the study period;
Key exclusion criteria (6 listed)
- Use of medications contraindicating increased consumption of fruits/vegetables (e.g., warfarin);
- Diagnosis of acute or chronic condition impacting appetite, food intake, and/or the metabolism and absorption of foods to be provided (e.g., Crohn's disease, Celiac disease, Ulcerative colitis, short bowel syndrome, chronic diarrhea);
- Impaired liver or kidney function;
- Food allergies to foods provided in either dietary intervention;
- Vegetarian, vegan; and
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 |
|---|---|---|
| Semi-controlled dietary intervention - WesternParticipants will complete a 2-week washout prior to a 16-week randomized, crossover semi-controlled feeding study of mini-MED vs Western diet. Each diet intervention will last four weeks, with 500 kcal/day of target Western diet foods (eg, beef, potatoes, bread, sour cream) provided during each intervention and will be repeated twice. | Other | Western |
| Semi-controlled dietary intervention - MiniMedParticipants will complete a 2-week washout prior to a 16-week randomized, crossover semi-controlled feeding study of mini-MED vs Western diet. Each diet intervention will last four weeks, with 500 kcal/day of target Mediterranean foods (eg, oatmeal, salmon, nuts, basil, olive oil, fruits) provided during each intervention and will be repeated twice. | Other | mini-Med |
Primary outcome
Foodomics
Time frame: Baseline to endline changes in food-specific compounds over each 4-week dietary intervention period
Change in the number of unique to food compounds (i.e., putative biomarkers of intake) from baseline to end of each diet intervention period in participant serum samples.
13 secondary outcomes
Cardiometabolic Health - IL-6
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - TNF-alpha
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - C-reactive protein
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - alpha-1-acid glycoprotein
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Total Cholesterol
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - LDL Cholesterol
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - HDL Cholesterol
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Triglycerides
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Blood Pressure
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Insulin
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Glucose
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Adipokines
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Gut Microbiota
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 38302990Hill EB, Tang M, Long JM, Kemp JF, Westcott JL, Hendricks AE, Reisdorph NA, Campbell WW, Krebs NF; mini-MED Trial Team. mini-MED: study protocol for a randomized, multi-intervention, semi-controlled feeding trial of a Mediterranean-amplified vs. habitual Western dietary pattern for the evaluation of food-specific compounds and cardiometabolic health. Trials. 2024 Feb 2;25(1):101. doi: 10.1186/s13063-024-07939-8.
- Derived from this study: PubMed 37918675Hill EB, Reisdorph RM, Rasolofomanana-Rajery S, Michel C, Khajeh-Sharafabadi M, Doenges KA, Weaver N, Quinn K, Sutliff AK, Tang M, Borengasser SJ, Frank DN, O'Connor LE, Campbell WW, Krebs NF, Hendricks AE, Reisdorph NA. Salmon Food-Specific Compounds and Their Metabolites Increase in Human Plasma and Are Associated with Cardiometabolic Health Indicators Following a Mediterranean-Style Diet Intervention. J Nutr. 2024 Jan;154(1):26-40. doi: 10.1016/j.tjnut.2023.10.024. Epub 2023 Oct 31.
- Individual participant dataSharing planned: Yes. 1) Data will be made available in accordance with the "Final NIH Statement on Sharing Research Data". Results, data, workflows, and tools will be made available through publication, presentations at scientific meetings, open access on our website following publication, in open repositories when they are established, and according to other policies set forth by the NIH. The primary type of data collected will be raw mass spectrometry data. There are widely available free-ware data converters for mass spectrometry data that have been created by the mass spectrometry community. Thus, the data from this project will be saved in the original raw format.
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Dietary Habits
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.
Nancy F Krebs, MD principal investigator
University of Colorado School of Medicine
Nichole Reisdorph, PhD principal investigator
University of Colorado School of Pharmacy
Wayne Campbell, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dietary Habits, 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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Aug 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?
Results are not available in the source record.
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?
Foodomics (time frame: Baseline to endline changes in food-specific compounds over each 4-week dietary intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05500976, which also lists 2 linked publications.
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 27 Aug 2024.