50 Participants Needed

Whole Grains vs Refined Grains for Metabolic Health

BR
Overseen ByBrett R Loman, PhD, RD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Illinois at Urbana-Champaign

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'?

Research shows that whole grain rye bread can help reduce cholesterol levels in men and improve insulin response, which may support better metabolic health compared to refined grains.12345

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

I am a healthy man or woman.

Exclusion Criteria

My doctor diagnosed me with stenosis.
I have been diagnosed with diabetes by a doctor.
I have been diagnosed with IBS by a doctor.
See 21 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1 day per crossover arm
1 visit (in-person) per arm

Follow-up

Participants provide a fecal sample for microbiome-related analyses and are monitored for any delayed effects.

1-2 days

Treatment Details

Interventions

  • Refined grain rye bread
  • Whole grain rye bread
Trial Overview The study tests how whole grain and refined grain rye bread affect the digestive system's movement patterns, the production of certain substances by gut microbes, and levels of blood sugar, fats like triglycerides and cholesterol after eating.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Whole grain rye breadExperimental Treatment1 Intervention
4.3 ounces of whole grain rye bread, consumed after an overnight fast (12+ hours)
Group II: Refined grain rye breadPlacebo Group1 Intervention
4.3 ounces of white rye bread, consumed after an overnight fast (12+ hours)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials
203
Recruited
40,600+

Findings from Research

Whole grain rye crisp bread (both unfermented and fermented) significantly increases feelings of fullness and reduces hunger compared to refined wheat crisp bread, with reported fullness 16% higher and hunger 11-12% lower after consumption.
Whole grain rye crisp bread also results in a lower postprandial insulin response, with unfermented rye crisp bread showing a 17% reduction in insulin response compared to refined wheat, suggesting that its dietary fiber content and microstructure contribute to these beneficial effects.
Effects of unfermented and fermented whole grain rye crisp breads served as part of a standardized breakfast, on appetite and postprandial glucose and insulin responses: a randomized cross-over trial.Johansson, DP., Lee, I., Risรฉrus, U., et al.[2018]
In a study involving 19 healthy postmenopausal women, rye breads resulted in significantly lower postprandial insulin and C-peptide responses compared to refined wheat bread, suggesting a beneficial effect on insulin metabolism.
The differences in insulin response were not solely due to fiber content, but rather structural differences in the rye breads, indicating that the physical properties of the bread may play a key role in glucose and insulin regulation.
Structural differences between rye and wheat breads but not total fiber content may explain the lower postprandial insulin response to rye bread.Juntunen, KS., Laaksonen, DE., Autio, K., et al.[2022]
In a study involving 121 type 2 diabetic patients, whole wheat, wheat bran, and rye breads did not significantly differ in their effects on blood glucose and insulin levels compared to white wheat bread.
All four types of bread led to similar increases in blood glucose levels, indicating that these alternative breads may not be effective substitutes for white bread in managing diabetes.
Dietary breads: myth or reality?Mesci, B., Oguz, A., Sagun, HG., et al.[2017]

References

Effects of unfermented and fermented whole grain rye crisp breads served as part of a standardized breakfast, on appetite and postprandial glucose and insulin responses: a randomized cross-over trial. [2018]
Structural differences between rye and wheat breads but not total fiber content may explain the lower postprandial insulin response to rye bread. [2022]
Dietary breads: myth or reality? [2017]
Postprandial glucose metabolism and SCFA after consuming wholegrain rye bread and wheat bread enriched with bioprocessed rye bran in individuals with mild gastrointestinal symptoms. [2018]
Rye bread decreases serum total and LDL cholesterol in men with moderately elevated serum cholesterol. [2018]
Associations of Whole Grain and Refined Grain Consumption With Metabolic Syndrome. A Meta-Analysis of Observational Studies. [2021]
Evaluation of the evidence between consumption of refined grains and health outcomes. [2015]
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