Corn and Heart Health Study

Completed · Not applicable

Conditions studied: Gut Microbiome, Cholesterol, LDL, Cholesterol, HDL

In brief

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.

Key facts

Study ID

NCT03967990

Run by

Arizona State University

People needed

58

Starts

2018-03-20

Expected to finish

2023-10-30

Last updated by the study team

2024-02-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Biomedical Collaborative — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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