CompletedNot Applicable

The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults

United States21 participantsStarted 2020-10-01

Plain-language summary

The Western diet pattern or standard American diet is a modern dietary pattern that is characterized by high intakes of meat, pre-packaged foods, fried foods, high-fat dairy products, eggs, refined grains etc. When considering the role of saturated fat, it may be prudent to advise limiting all foods that contain saturated fats, including unprocessed/minimally processed meat, eggs, whole dairy in addition to processed, pre-packaged foods; however, this reductionist approach fails to take into account the food matrix and overall diet in which these nutrients are consumed. Epidemiological evidence suggests that increased modern, pre-packaged food consumption is a major risk factor for metabolic disease by promoting inflammation. Based on these data, the investigators hypothesize that the pro-atherogenic effect of the Western diet is caused by the pro-inflammatory effects of consuming large amounts of modern ultra-processed foods, and that consumption of a similar amount of fat from minimally processed beef, poultry, dairy, eggs, as part of an unprocessed diet will positively impact inflammatory markers and lipoprotein profiles of study participants when compared to a diet rich in modern ultra-processed foods.

Who can participate

Age range35 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥35 and ≤60 years; * BMI ≥25 and ≤35 kg/m2; * Weight stable in last 3 months (Loss or gain \<4%); * Consistent physical activity levels; * Hemoglobin A1C (HbA1C) ≤6.4%; * Fasting insulin; \<15 µU/mL; * Fasting plasma glucose concentration \<126 mg/dl; * Willingness to eat the food provided in this study; * Subjects must be able to speak and understand English to participate in this study * Own a smartphone or other mobile device capable of downloading the Garmin Connect app. Exclusion Criteria: * Diagnoses of active malignancy, congestive heart failure, diabetes mellitus, chronic obstructive pulmonary disease, thyroid disease or other metabolic disorders that influence metabolism; * Evidence of impaired kidney function (Estimated glomerular filtration rate \[eGFR\] \<44 mL/min; * Regular use of medication that interferes with the measurement of study outcomes as determined by the study team (e.g., NSAIDs, corticosteroids); * Consuming \>14 drinks per week of \>4 drinks per night twice/week for male; \>7 drinks per week or \>3 drinks per night twice/week for female; * Use of cigarettes (or other tobacco products) or use of any other (recreational) drug in last 3 months; * Engaged in high-level competitive exercise (e.g., marathons, triathlons, cycling, weight-lifting competitions etc.) * Self-reported sleep duration \<5 hours per night; * Any inflammatory diseases (e.g. asthma, autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, in…

What they're measuring

Change in plasma interleukin-6 levels

Timeframe: Baseline, up to 4 weeks.

Change in plasma c-reactive protein levels

Timeframe: Baseline, up to 4 weeks.

Change in plasma acylcarnitine profiles

Timeframe: Baseline, up to 4 weeks.

Trial details

NCT IDNCT04275843

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-21

View on ClinicalTrials.gov More Healthy Diet trials

Plain-language summary

Who can participate

Age range35 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.