Trials / Completed
CompletedNCT04275843
The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 35 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Traditional Diet | Consuming an traditional whole foods based diet for 4 weeks. |
| DIETARY_SUPPLEMENT | Modern Diet | Consuming an processed formulation of the traditional diet for 4 weeks. |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2021-12-21
- Completion
- 2021-12-21
- First posted
- 2020-02-19
- Last updated
- 2022-07-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04275843. Inclusion in this directory is not an endorsement.