Duke University School of Medicine
Durham, North Carolina, 27701, United States
NCT Number: NCT04275843
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.
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Notify Me35 year–60 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27701, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consuming an traditional whole foods based diet for 4 weeks.
Consuming an processed formulation of the traditional diet for 4 weeks.
Time frame: Baseline, up to 4 weeks.
Plasma interleukin-6 levels will be measured before and after each diet
Time frame: Baseline, up to 4 weeks.
Plasma c-reactive protein levels levels will be measured before and after each diet
Time frame: Baseline, up to 4 weeks.
Plasma acylcarnitines profiles levels will be measured before and after each diet
Time frame: Baseline, up to 4 weeks.
Bifidobacterium, Faecalibacterium prausnitzii, Anerostipes, Roseburia
Time frame: up to 4 weeks.
Measured by the doubly labeled water method during the last week of each diet
Time frame: Baseline, up to 4 weeks.
Neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Aß42 and p-tau will be measured before and after each diet
Duke University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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