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Berries, Inflammation, and Gut Microbiome

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study completion date: Jan 1, 2026 to Oct 1, 2026v11
  2. Study completion date: Jan 1, 2025 to Jan 1, 2026v10
  3. Study completion date: Feb 1, 2024 to Jan 1, 2025v9
  4. Study completion date: Aug 1, 2023 to Feb 1, 2024v8
  5. Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
    • Enrollment target: estimated 88 to confirmed 105
    • Primary completion date changed from estimate of Apr 1, 2023 to Mar 31, 2023
    • Study completion date: Apr 1, 2023 to Aug 1, 2023
    • Site details revised
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Oct 2022 to Apr 1, 2023
    • Study completion date: Dec 2022 to Apr 1, 2023
    v6
  2. Primary completion date: Oct 2021 to Oct 2022
    • Study completion date: Sep 2022 to Dec 2022
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Primary endpoints revised (3)
    • Eligibility criteria revised
    • Secondary endpoints revised (2)
    • Collaborators expanded, about 6 words
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2019 to Oct 7, 2019
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04100200
Lead Sponsor Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborators: USDA Beltsville Human Nutrition Research Center
Conditions
(from sponsor)		 Overweight or Obesity, Healthy
Related terms Obesity, Overweight
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov