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

NCT07840170 — Not applicable, Not yet recruiting, 24 participants, Purdue University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07840170
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: triple, basic science
Enrollment	24 (Estimated)
Sponsor	Purdue University (Other); collaborators: Rush University Medical Center
Conditions	Prediabetes or Overweight
Interventions	Whole food fiber mixture, inulin (Dietary supplement)
Dates	start 2026-11-01 (estimated), primary completion 2027-02-28 (estimated), completion 2027-04-30 (estimated), first posted 2026-09-24, last updated 2026-09-24
Locations	1 site in United States

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Whole food fiber mixture	Experimental	Dietary Supplement: Whole food fiber mixture	For a duration of 4 weeks, participants will consume 2 servings per day of a whole-food fiber powder mixture designed by the research team. This intervention period will be followed by a 4-week washout period during which participants will not consume any dietary supplements.
Inulin	Active comparator	Dietary Supplement: inulin	For a duration of 4 weeks, participants will consume 2 servings per day of a commercially available Inulin. This intervention period will be followed by a 4-week washout period during which participants will not consume any dietary supplements.

Whole food fiber mixture (Dietary 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.
inulin (Dietary 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.

+Outcome measures

Primary outcomes

Colonic butyrogenic Clostridium clusters IV and XIVa [Outcomes will be analyzed at the beginning (week 0 and week 8) and end of each supplementation period (week 4 and week 12).]: 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 [Outcomes will be analyzed at the beginning (week 0 and week 8) and end of each supplementation period (week 4 and week 12).]: 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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Clinical Research Center at Purdue University	West Lafayette, Indiana	United States

+Investigators

Thaisa M Cantu-Jungles, PhD, Principal investigator, Purdue University

+Funding

NIH grants: 2023