Whole-Grain Corn for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the body processes whole-grain corn compared to refined corn. Researchers aim to identify specific markers in the body after consuming these types of corn to better understand the benefits of whole grains. Participants will consume both types of corn in a controlled setting to observe how each is processed. Healthy adults who do not smoke, have no food allergies, and do not currently have any major health issues may be suitable for this study. As an unphased trial, this study allows participants to contribute to important nutritional research that could enhance dietary guidelines.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both whole-grain and refined corn are generally safe to eat. Refined corn products, in particular, have a strong safety record and rank among the safest food ingredients, with no major side effects reported and no FDA recalls. Whole-grain corn is also mostly safe, though it can sometimes contain natural contaminants like mycotoxins, harmful substances produced by mold. Quality checks in food production usually control these contaminants. While neither type of corn is dangerous, inhaling corn dust can irritate the nose and throat. Consuming large amounts of corn might have a laxative effect, but otherwise, both whole-grain and refined corn are well-tolerated by most people.12345
Why are researchers excited about this trial?
Researchers are excited about these treatments because they focus on dietary interventions using whole-grain corn and refined corn, which are not typical options for improving health in adults. Unlike traditional dietary approaches that may involve supplements or complex diet plans, this study looks at the effects of consuming whole foods directly. Whole-grain corn offers a unique nutritional profile, rich in fiber and antioxidants, which might provide health benefits that refined corn lacks. The trial aims to compare how the body processes these two types of corn, potentially shedding light on their impacts on health markers like blood sugar and cholesterol.
What evidence suggests that this trial's treatments could be effective for identifying biomarkers of corn intake?
This trial will compare the effects of whole-grain corn and refined corn on health markers in adults. Studies have shown that whole-grain corn is rich in fiber, vitamins, and antioxidants, which can help lower the risk of long-term illnesses like heart disease, type 2 diabetes, and obesity. Regular consumption of whole grains is linked to better heart health and improved metabolism. In contrast, refined corn products, such as cornflakes, usually contain less fiber and fewer nutrients, potentially offering fewer health benefits. While refined corn can still support eye health and digestion, it lacks the nutritional profile of whole-grain corn. Overall, whole-grain corn is a healthier choice for reducing disease risk and promoting well-being. Participants in this trial will consume both whole-grain and refined corn in different sequences to assess their effects.678910
Are You a Good Fit for This Trial?
This trial is for healthy adult men and women. People with health conditions or on medications that could affect the study results are likely excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Wash-in Period
Participants avoid consuming whole-grain products before the intervention
Pharmacokinetic Visit 1
Participants consume either whole-grain or refined-grain corn; blood and urine samples collected over 48 hours
Washout Period
Participants undergo a washout period before crossing over to the alternate treatment
Pharmacokinetic Visit 2
Participants consume the alternate grain type; blood and urine samples collected over 48 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Refined Corn
- Whole-Grain Corn
Trial Overview
The study compares how the body absorbs and processes phytochemicals from whole-grain corn versus refined corn. Participants eat both types in a randomized order, and their blood is tested to find markers of corn intake.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will complete a 7-day wash-in period during which they will avoid consuming whole-grain products. During Pharmacokinetic (PK) Visit 1 (Day 8), participants will consume whole-grain corn. After a 6-day washout period, participants will cross over and consume refined corn during PK Visit 2 (Day 15). Blood and urine samples will be collected over 48 hours following each intervention.
Participants will complete a 7-day wash-in period during which they will avoid consuming whole-grain products. During Pharmacokinetic (PK) Visit 1 (Day 8), participants will consume refined corn. After a 6-day washout period, participants will cross over and consume whole-grain corn during PK Visit 2 (Day 15). Blood and urine samples will be collected over 48 hours following each intervention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
North Carolina Agriculture & Technical State University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
Evaluating the Effects of Corn Flour Product Consumption ...
Consumption of whole grains is associated with a reduction in chronic diseases and offers benefits for cardiovascular health and metabolic regulation.
Dry‐Milled Corn and Corn Products and Health: A ...
This review describes research regarding products of dry-milled corn (maize) including potential health implications.
Corn 101: Nutrition Facts and Health Benefits
It may promote eye and digestive health. Refined corn products, however, such as tortilla chips, offer fewer health benefits. Also known as maize (Zea mays), ...
Effects of Corn Flour Consumption on Human Health across ...
refined corn products, such as cornflakes and extruded snacks, were linked to less favorable metabolic outcomes, particularly in individuals ...
Study Details | NCT03967990 | Corn and Heart Health Study
The purpose of this study is to investigate the effects of 3 different corn flours: (1) whole grain corn flour, (2) 50% refined corn flour + 50% corn bran ...
Safety Data Sheet
Immediate Effects No information on significant adverse effects. Delayed Effects e effects. Irritation/Corrosivity Data. Reproductive Toxicity. Medical ...
Product Safety and Quality
Refined corn products are considered some of the safest human food ingredient products available today, with a long track record of no FDA mandated recalls.
Safety Data Sheet
Avoid contact with skin, eyes, and clothing. Protect from freezing and physical damage. Corrosion Irritation: Other adverse effects: Not ...
MATERIAL SAFETY DATA SHEET PAGE 1 OF X
Corn is considered non-hazardous. dust in air suspension may become explosive under confined conditions. in asthma, bronchitis, chronic ...
Safety of Corn and Corn-Based Products Intended for Human ...
It has been reported that germ and pericarp are the corn fractions most contaminated by mycotoxins [29,30,31]. Dietary exposure degree is an ...
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