Corn and Heart Health Study (NCT03967990) | Clinical Trial Compass
CompletedNot Applicable
Corn and Heart Health Study
United States58 participantsStarted 2018-03-20
Plain-language summary
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 derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy English and Spanish speaking males and females with elevated circulating cholesterol levels (LDL-c ≥ 120 mg/dL).
* Individuals with LDL-c \> 190 mg/dL will be permitted to participate but must provide a letter from their doctor stating that they are comfortable with their participation in the study.
Exclusion Criteria:
* recent weight fluctuations (\> 5 lb in past 3 months), following specialized or restrictive diets (e.g. carbohydrate restriction, veganism)
* use of supplements (antioxidants, fiber, botanicals)
* allergies to dairy, egg, wheat, corn or gluten
* use of antibiotics in the past 2-3 months
* use of lipid lowering medications
* regular physical activity ≥ 30 min/d for ≥ 5 days/wk
* history of thyroid disorders, diabetes, heart disease, cancer, hepatitis, inflammatory conditions and/or gastrointestinal disorders which may impact gut function and metabolism
* anyone with a fear of needles or blood draws
* If female, women may not be pregnant or lactating during the study.
* Unwillingness to comply with study protocols will also result in exclusion from the study.
* Participants in this study will not be eligible if they are participating in other research studies at the same time.