Healthy Clinical Trial
Official title:
Polyphenols and Human Gut Microbiome Interactions: Role of in Ameliorating Inflammation
Verified date | December 2023 |
Source | Clinical Nutrition Research Center, Illinois Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 105 |
Est. completion date | February 1, 2024 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Nutrition Research Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Clinical Nutrition Research Center, Illinois Institute of Technology | USDA Beltsville Human Nutrition Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Characterize metabolite profiles (phenolic acids and urolithin derivatives) in urine and plasma. | Polyphenolic metabolites (anthocyanin, ellagitannins and other phenolic components) will be identified and quantified in urine and plasma.Metabolites in samples will be identified and quantified using an Agilent 6550 iFunnel UHPLC-QTOF-MS and 6460 UHPLC-QQQ-MS, respectively. | Baseline to 4 weeks | |
Primary | Changes in plasma biomarkers and measures of inflammation concentration: Nrf2/ NF-?B -response between 4 treatments | Plasma biomarkers and measures of inflammation: Nrf2/ NF-?B activation in monocytes will be analyzed. | Baseline to 4 weeks | |
Primary | Changes in plasma biomarkers and measures of inflammation concentration-response between 4 treatments | Inflammatory cytokines (Interleukin-6 (IL-6), High Sensitivity C-Reactive Protein (hs-CRP), Tumor Necrosis Factor-a (TNF-a)) will be measured. | Baseline to 4 weeks | |
Primary | Changes in plasma biomarkers and measures of inflammation concentration (GLP-2)-response between 4 treatments | Analysis of GLP-2 will be done in plasma samples before and after chronic exposure to the study foods. | Baseline to 4 weeks | |
Secondary | Changes in gut inflammatory markers between 4 treatments. | The concentration of calprotectin, zonulin, and IgA in fecal samples will be determined by enzyme-linked immunosorbent assay (ELISA) before and after chronic exposure to study foods. | Baseline to 4 weeks | |
Secondary | Changes in Bile acids between 4 treatments. | Bile acids in plasma and fecal samples will be determined using UHPLC-QQQ-MS. | Baseline to 4 weeks |
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