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Clinical Trials in the USA / NCT04100200
Active, not recruiting Not applicable

Berries, Inflammation, and Gut Microbiome

NCT04100200 · tracked via the Priya Life Science USA tracker
Sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology
Phase
Not applicable
Started
2019-10-07
Last updated
2026-03-25

Condition(s) studied

Overweight or ObesityHealthy

Investigational drug(s) / intervention(s)

Mixed berriesFOSControlCombination

Mixed berries: Strawberry and red raspberry

FOS: Fructo-oligosaccharide

Control: Placebo similar in color to mixed berry supplement without any polyphenols

Combination: Mixed berry composite + FOS

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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria * C-Reactive Protein (hs-CRP) \> 1.0 and ≤ 10 ng/L * BMI ≥ 25 kg/m2 * Aged 20-60 years * Able to provide informed consent and comply with study procedures * Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial. * Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests. * People with no documented disease condition that would interfere with the study endpoints (ie., CVD, diabetes, hypertension, major organ diseases) or taking medication or dietary supplements that may interfere with study endpoints Exclusion Criteria * Current smoker or marijuana user * No history or presence of atherosclerosis/cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes. * Taking any medications and/or supplements that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, etc) * Take part in prebiotics, probiotics or drugs active on gastrointestinal motility or a laxative of any class within 1 month * Unstable use of any medication/supplement, this could include marijuana used as -needed for medical reasons * Have a history of cancer, except for non-melanoma skin cancer in past 5 years * Addicted to drugs and/or alcohol (\>4 drinks/day) * Have been exposed to any non-registered drug product within last 30 days. * Working overnight (e.g. 3rd shift of overnight workers) * Excessive exercisers or trained athletes * Have allergies/intolerances to any of the study products. * Extreme dietary habits (ie. vegetarian/vegan) * Excessive coffee/tea drinker (\>4 cups/day) * Actively losing weight/ trying to lose weight (unstable body weight fluctuations of \> 5 kg in 3 months) * Donated blood within last 3 months * Participated in a clinical trial within 1 month * Female who is pregnant, planning to be pregnant, breastfeeding * Any condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound

Primary outcome measure(s)

  • Changes in plasma biomarkers and measures of inflammation concentration: Nrf2/ NF-κB -response between 4 treatments — Baseline to 4 weeks
    Plasma biomarkers and measures of inflammation: Nrf2/ NF-κB activation in monocytes will be analyzed.
  • Changes in plasma biomarkers and measures of inflammation concentration-response between 4 treatments — Baseline to 4 weeks
    Inflammatory cytokines (Interleukin-6 (IL-6), High Sensitivity C-Reactive Protein (hs-CRP), Tumor Necrosis Factor-α (TNF-α)) will be measured.
  • Changes in plasma biomarkers and measures of inflammation concentration (GLP-2)-response between 4 treatments — Baseline to 4 weeks
    Analysis of GLP-2 will be done in plasma samples before and after chronic exposure to the study foods.

Trial sites (1)

FacilityCityRegionStatus
Clinical Nutrition Research Center Chicago Illinois

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04100200 on ClinicalTrials.gov ↗ ← All trials in the USA