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NCT04275843 · ClinicalTrials.gov registry record · NA
The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04275843: Completed NA study, sponsored by Duke University.
NCT04275843 is a NA study that has completed, run by Duke University. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04275843, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
Plasma interleukin-6 levels will be measured before and after each diet
Interventions
- DIETARY_SUPPLEMENT Traditional Diet
- DIETARY_SUPPLEMENT Modern Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2021-12-21 |
| Phase | NA |
What the finished NCT04275843 record still lists
NCT04275843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Traditional Diet is the first listed.
NCT04275843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04275843 about?
NCT04275843 is a clinical study titled "The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults". 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...
What is the current status of trial NCT04275843?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2020-10-01. Estimated completion is 2021-12-21.
What interventions are being tested in trial NCT04275843?
The interventions under investigation include: Traditional Diet (DIETARY_SUPPLEMENT), Modern Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04275843?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04275843's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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