An interventional study of Traditional Diet and Modern Diet in Healthy Diet, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-13.
Sponsored by Duke University · Not applicable, Interventional, and Basic science
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Unprocessed/minimally processed whole foods.
Dietary Supplement: Traditional Diet
Multi-ingredient, ultra-processed formulations of the traditional diet.
Dietary Supplement: Modern Diet
Consuming an traditional whole foods based diet for 4 weeks.
Consuming an processed formulation of the traditional diet for 4 weeks.
Change in plasma interleukin-6 levels
Plasma interleukin-6 levels will be measured before and after each diet
Time frame: Baseline, up to 4 weeks.
Change in plasma c-reactive protein levels
Plasma c-reactive protein levels levels will be measured before and after each diet
Time frame: Baseline, up to 4 weeks.
Change in plasma acylcarnitine profiles
Plasma acylcarnitines profiles levels will be measured before and after each diet
Time frame: Baseline, up to 4 weeks.
Change in gut microbiota communities
Bifidobacterium, Faecalibacterium prausnitzii, Anerostipes, Roseburia
Time frame: Baseline, up to 4 weeks.
Energy expenditure
Measured by the doubly labeled water method during the last week of each diet
Time frame: up to 4 weeks.
Change in Neuroinflammation
Neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Aß42 and p-tau will be measured before and after each diet
Time frame: Baseline, up to 4 weeks.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Duke University