Whole Food Fibers for Support of Key Gut Bacteria for Human Health

N/ANot Yet RecruitingNCT07840170

Purdue University24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Prediabetes or Overweight

Interventions

Whole food fiber mixtureDIETARY_SUPPLEMENT

Participants 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.

inulinDIETARY_SUPPLEMENT

Participants 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Kidney dysfunction * Thyroid dysfunction * Liver dysfunction * Use of antibiotics in the last four weeks * Use of probiotics in the last four weeks * Use of prebiotics in the last four weeks

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.

Time frame: Outcomes will be analyzed at the beginning (week 0 and week 8) and end of each supplementation period (week 4 and week 12).

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.