NCT03967990

Corn and Heart Health Study

Evaluating the Effects of Corn Flour Consumption on Cardio-metabolic Outcomes and the Gut Microbiome in Adults With High Cholesterol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Arizona State University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Dietary fibers are extremely complex and foster health in a variety of ways that are not fully understood. The Adequate Intake of fiber (14 g per 1000 kcal consumed) is based on data that strongly support a relationship with cardiovascular disease prevention (Slavin, 2013). While cereal fibers have been shown to be most effective at reducing cardiovascular disease risk (IOM, 2002), the components of dietary fiber (e.g. germ, bran) that exert this effect remain inadequately studied in cardiometabolic outcomes. Further, specific types of dietary fiber (natural and synthetic) have been shown to increase beneficial microbial species in the gastrointestinal tract, which are accompanied by improvements in inflammatory and metabolic disease markers. Very little is known about how isolated or intact fiber in whole grains solicit beneficial health effects via microbial mechanisms. Our goal is to study both changes in cardiometabolic outcomes and the gut microbiome after consuming different types of corn-based meals. Aim 1: To evaluate cardio-metabolic outcomes (primary outcome: LDL cholesterol) after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design. Aim 2: To evaluate changes in the gut microbiome after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design.

Conditions

• Gut Microbiome
• Cholesterol, LDL
• Cholesterol, HDL

Interventions

Type	Name	Description
OTHER	Refined cornmeal flour	48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins
OTHER	50/50 refined cornmeal-bran mix	48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins
OTHER	Whole grain cornmeal flour	48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Timeline

• Start date: 2018-03-20
• Primary completion: 2023-08-30
• Completion: 2023-10-30
• First posted: 2019-05-30
• Last updated: 2024-02-05

Locations

1 site across 1 country: United States