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

NCT07840170 | Not Yet Recruiting

• 3 other identifiers: IRB-2022-16592023-67017-400132023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prediabetes or Overweight

Keywords

whole foods; dietary fiber; prebiotics; gut microbiota; gut health

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• 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).

Study Arms (2)

Whole food fiber mixture

EXPERIMENTAL

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.

Dietary Supplement: Whole food fiber mixture

Inulin

ACTIVE COMPARATOR

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.

Dietary Supplement: inulin

Interventions

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.

Whole food fiber mixture

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.

Inulin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years age

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead
• Rush University Medical Center: collaborator

Study Sites (1)

Clinical Research Center at Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Prediabetic State; Overweight

Interventions

Inulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Thaisa M Cantu-Jungles, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thaisa Cantu Jungles

CONTACT

765-494-7997; tcantuju@purdue.edu

Bruce Hamaker, PhD

CONTACT

765-418-1995; hamakerb@purdue.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

US (1)