Whole Grains vs Refined Grains for Metabolic Health
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications to participate in this trial. Specifically, you cannot be using statins, oral hypoglycemic agents, insulin, prescription fiber, cholesterol and bile acid absorption inhibitors, anti-histamines, proton pump inhibitors, or antacids.
What data supports the effectiveness of the treatment 'Whole Grains vs Refined Grains for Metabolic Health'?
Is rye bread safe for human consumption?
Rye bread, including whole grain and refined varieties, has been studied for its effects on glucose and insulin levels, cholesterol, and appetite. These studies suggest that rye bread is generally safe for human consumption and may even offer health benefits like reducing cholesterol and improving insulin response.12345
How does the treatment of whole grain rye bread differ from other treatments for metabolic health?
Whole grain rye bread is unique because it can improve glucose metabolism and reduce insulin response after meals, which may help with metabolic health. Unlike refined grains, whole grains like rye are associated with a lower risk of metabolic syndrome, making them a healthier option for managing metabolic conditions.12467
What is the purpose of this trial?
The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol.Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses.
Eligibility Criteria
This trial is for individuals with cardiovascular or metabolic diseases, an imbalance of gut microbes, nutritional issues, or gastrointestinal dysfunction. Participants will need to be comfortable consuming different types of rye bread and using a Smartpill device to monitor their digestive system.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume a Smartpill monitoring device and either whole or refined grain rye bread, followed by monitoring of gastrointestinal motility and cardiometabolic metabolites over an 8-hour postprandial window.
Follow-up
Participants provide a fecal sample for microbiome-related analyses and are monitored for any delayed effects.
Treatment Details
Interventions
- Refined grain rye bread
- Whole grain rye bread
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Urbana-Champaign
Lead Sponsor