Whole Food Fibers for Prediabetes

BH
TC
Overseen ByThaisa Cantu Jungles
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Purdue University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

TM

Thaisa M Cantu-Jungles, PhD

Principal Investigator

Purdue University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who are overweight (BMI 25-35) and have prediabetes. Participants must not have any colon diseases, inflammatory bowel disease, wheat allergies or intolerance, and cannot be pregnant or nursing.

Inclusion Criteria

Overweight or obese, defined as a Body Mass Index (BMI) of 25 to 35 kg/m²
Prediabetic with HbA1c between 5.7 and 6.3, though otherwise healthy subjects
I am between 18 and 65 years old.

Exclusion Criteria

I have taken probiotics in the past four weeks.
I have a thyroid disorder.
I have liver dysfunction.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Inulin
  • Whole food fiber mixture

Trial Overview

The study compares the effects of a whole food fiber mixture versus inulin (a common fiber supplement) on gut bacteria and health. Each participant will try both treatments in random order over a total of 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Whole food fiber mixtureExperimental Treatment1 Intervention
Group II: InulinActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials
239
Recruited
72,200+

Rush University Medical Center

Collaborator

Trials
448
Recruited
247,000+