Clinical Trial

Berries, Inflammation, and Gut Microbiome

Active, Not Recruiting
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Summary
The primary objectives are to characterize changes in indices of systemic and gut inflammation, assess host- and microbial-derived metabolite pools, and describe and link functional metagenomics and metatranscriptomic alterations in the gut microbiome with metabolite and inflammatory outcomes after acute (24hr) and chronic (4 week) intake of anthocyanins and ellagitannins from strawberry and red raspberries compared to a control diet (negative control), FOS (positive control, non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic), or combination diet (berry composite + FOS) in human participants with low-grade inflammation.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2019-09-19; most recent amendment 2026-03-24.
Status change: Recruiting → Active, Not Recruiting 2023-05-02
Status change: Not Yet Recruiting → Recruiting 2020-02-05
Trial Details
NCT Number NCT04100200
Lead Sponsor Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborators: USDA Beltsville Human Nutrition Research Center
Conditions Overweight or Obesity, Healthy
Enrollment 105 participants
Start Date 2019-10-07
Primary Completion 2023-03-31 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-25