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

Conditions

• Prediabetes or Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

First listed

Sep 24, 2026

Start date

Nov 1, 2026

Status verified

Sep 2026

Primary completion

Feb 28, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: 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.
• Active Comparator: 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.

Primary Outcome Measure

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). ]

Central Contacts

• Thaisa Cantu Jungles
  765-494-7997
  [email protected]
• Bruce Hamaker, PhD
  765-418-1995
  [email protected]

Locations (1)

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