NCT04100200Active, not recruiting
Berries, Inflammation, and Gut Microbiome
Polyphenols and Human Gut Microbiome Interactions: Role of in Ameliorating Inflammation
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 18 Sept 2019
- Start date
- Oct 2019
- Primary completion date
- Mar 2023
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Diseases
- Obesity
- NCT number
- NCT04100200
What you commit to
- Study type: Interventional
- Participants enrolled: 105
- From Oct 2019 to the primary completion date, Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Addicted to drugs and/or alcohol (\>4 drinks/day)
- Have been exposed to any non-registered drug product within last 30 days.
Other illness
- 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.
- Have a history of cancer, except for non-melanoma skin cancer in past 5 years
- Have allergies/intolerances to any of the study products.
- 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
Other
- Current smoker or marijuana user
- Working overnight (e.g. 3rd shift of overnight workers)
- Excessive exercisers or trained athletes
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Nutrition Research Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.