An interventional study of Semi-controlled dietary intervention - Western and Semi-controlled dietary intervention - MiniMed in Dietary Habits, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in United States. Open to participants aged 30 Years to 69 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Basic science
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.
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.
University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: Semi-controlled dietary intervention - MiniMed
Habitual/Western (Western) diet, containing 500 kcal/day from non-Mediterranean target foods (such as potato, beef, sour cream, refined grain bread, chocolate dessert).
Other: Semi-controlled dietary intervention - Western
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.
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.
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.
Time frame: Baseline to endline changes in food-specific compounds over each 4-week dietary intervention period
Cardiometabolic Health - IL-6
Changes in blood inflammatory markers including IL-6 over time and between the two dietary interventions.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Gut Microbiota
Changes in diversity and community composition of the gut microbiota.
Time frame: Baseline to endline changes over each 4-week dietary intervention period
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
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This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver