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Berries, Inflammation, and Gut Microbiome

NCT04100200 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Overweight or Obesity
  • Healthy

Interventions

DIETARY_SUPPLEMENT

Mixed berries

Strawberry and red raspberry

DIETARY_SUPPLEMENT

FOS

Fructo-oligosaccharide

DIETARY_SUPPLEMENT

Control

Placebo similar in color to mixed berry supplement without any polyphenols

DIETARY_SUPPLEMENT

Combination

Mixed berry composite + FOS

Sponsors & Collaborators

  • USDA Beltsville Human Nutrition Research Center

    collaborator FED

  • Clinical Nutrition Research Center, Illinois Institute of Technology

    lead INDUSTRY

Principal Investigators

  • Amandeep Sandhu, Ph.D · Institue for Food Safety and Health/Illinois Insititute of Technology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2023-03-31
Completion
2026-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04100200 on ClinicalTrials.gov