Whole Food Fibers for Prediabetes
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?
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
Exclusion Criteria
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
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Purdue University
Lead Sponsor
Rush University Medical Center
Collaborator
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