About this trial
The purpose of this supplementation study is to understand how whole food fibers may affect gut microbiota composition and overall health. The investigators will enroll up to 24 people in this study. To be eligible, participants need to be between 18 and 65 years old, have a Body Mass Index of 25 to 35 kg/m², be prediabetic (HbA1c: 5.7 - 6.3), be free of any inflammatory bowel disease or any colon-related disease, be free of wheat allergens or intolerance, and not be pregnant or nursing. If participants have any questions about the criteria, they will ask the investigator consenting them. This is a randomized, cross-over, double-blind, clinical trial (RCT) that will last 12 consecutive weeks in total (4 weeks of treatment A + 4 weeks of washout + 4 weeks of treatment B). The order of the treatments will be randomly assigned before the beginning of the study. If proved right, this study will provide a science-based fiber reason why consumption of whole foods constitutes a better dietary approach than the current practice of adding soluble dietary fiber (inulin) alone to modulate gut microbiota for gut and whole-body health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Overweight or obese, defined as a Body Mass Index (BMI) of 25 to 35 kg/m²
Prediabetic (HbA1c: 5.7 - 6.3), though otherwise healthy subjects
18-65 years age
Disqualifiers
Kidney dysfunction
Thyroid dysfunction
Liver dysfunction
Use of antibiotics in the last four weeks
Trial design
Crossover
Treatments tested in this trial
Whole food fiber mixture
Dietary supplementParticipants will consume 2 servings per day of a whole-food fiber-based mixture packaged in the form of a sachet, prepared by an external manufacturer , and diluted in 100 mL of water prior to consumption. Each serving contains 7.5 g of a whole-food fiber mixture (designed by the research team), 0.7 g of flavor (berry, banana, or lemon), 0.2 g of guar gum (thickening agent), 0.5 g citric acid, and 0.1 g stevia.
inulin
Dietary supplementParticipants will consume 2 servings per day of an inulin packaged in the form of a sachet, prepared by an external manufacturer, and diluted in 100 mL of water prior to consumption. Each serving contains 7.5 g of commercially sourced isolated inulin, 0.7 g of flavor (berry, banana or lemon), 0.2 g of guar gum (thickening agent), 0.5 g citric acid, and 0.1g stevia.
Treatment groups
Trial outcomes
Primary outcomes
Colonic butyrogenic Clostridium clusters IV and XIVa
Changes in composition of bacterial taxa belonging to Clostridium clusters IV and XIVa will be assessed following consumption of the whole-food fiber mixture compared with inulin using 16S rRNA gene sequencing of fecal samples.
Secondary outcomes
Blood markers of gut and systemic health effects
Mesures in blood of gut metabolites: short-chain fatty acid (SCFAs) concentrations (mM). Measures of intestinal barrier integrity: zonulin (ng/mL), intestinal fatty acid-binding protein (ng/mL). Measures of bacterial translocation in the gut: lipopolysaccharide \[LPS\] (ng/mL), LPS-binding protein (ng/mL). Measures of systemic inflammatory cytokines: IL-1, IL-6, IL-8, TNF-alpha and IL-10 (pg/mL). Measure of metabolic health: HOMA-IR.
Sponsors and contacts
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Purdue University
Lead sponsor
Rush University Medical Center
Collaborator
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