Status:
ACTIVE_NOT_RECRUITING
Berries, Inflammation, and Gut Microbiome
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborating Sponsors:
USDA Beltsville Human Nutrition Research Center
Conditions:
Overweight or Obesity
Healthy
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief 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 m...
Detailed Description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Te...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04100200
Start Date
October 7 2019
End Date
January 1 2026
Last Update
May 8 2025
Active Locations (1)
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1
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616