The gastrointestinal (GI) ecosystem is a complex network of bacterial cells, host cells and tissues that change with age. Fewer numbers and less diversity of beneficial bacteria and greater number and diversity of non-beneficial bacteria occurs with age and conditions associated with accelerated aging (i.e. obesity, high fat diet)(1,2). This imbalance of the microbiota contributes to increased inflammation of the gastrointestinal lining and changes to the integrity of the intestinal cell wall. Prebiotics, such as non-digestible carbohydrates, can induce the growth or activity microorganisms that contribute to the well-being of the host. Recent studies have shown that prebiotic treatment can have beneficial effects on glucose levels, lipid metabolism, and inflammatory markers in an obese population(3). The polyphenol blend is rich in anthocyanins, which is a unique subgroup of flavonoids that have been demonstrated to impact the microbiome and have anti-inflammatory properties(4,5,6,7). This open-label study will assess the benefits of a prebiotic and polyphenol blend in healthy obese adults.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
51
KGK Synergize Inc.
London, Ontario, Canada
Change from baseline in microbial composition in the feces at day 57
Time frame: Baseline, Day 57
Change from baseline in calprotectin in the feces at day 57
Time frame: Baseline, Day 57
Change from baseline in IL-6 in the feces at day 57
Time frame: Baseline, Day 57
Change from baseline in IL-8 in the feces at day 57
Time frame: Baseline, Day 57
Change from baseline in IL-10 in the feces at day 57
Time frame: Baseline, Day 57
Change from baseline in IL-1β in the feces at day 57
Time frame: Baseline, Day 57
Change from baseline in IL-12p70 in the feces at day 57
Time frame: Baseline, Day 57
Change from baseline in TNFα in the feces at day 57
Time frame: Baseline, Day 57
Change from baseline in urine sugar test for gut permeability at day 57
Time frame: Baseline, Day 57
Change from baseline in plasma zonulin at day 57
Time frame: Baseline, Day 57
Change from baseline in Total Cholesterol at day 57
Time frame: Baseline, Day 57
Change from baseline in HDL-C at day 57
Time frame: Baseline, Day 57
Change from baseline in LDL-C at day 57
Time frame: Baseline, Day 57
Change from baseline in Triglycerides at day 57
Time frame: Baseline, Day 57
Change from baseline in weekly mean of daily Bristol Stool Scale (BSS) scores at day 57
Time frame: Baseline, Day 57
Change from baseline in plasma endotoxin at day 57
Time frame: Baseline, Day 57
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.