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NCT Number: NCT07840170

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center at Purdue University

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Colonic butyrogenic Clostridium clusters IV and XIVa

    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).

    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

  1. Blood markers of gut and systemic health effects

    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).

    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.

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Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Rush University Medical Center

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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