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Completed

NCT Number: 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 derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Biomedical Collaborative

Phoenix, Arizona, 85007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Refined cornmeal flour

Other

48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

50/50 refined cornmeal-bran mix

Other

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

Whole grain cornmeal flour

Other

48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Primary outcomes

  1. LDL Cholesterol

    Time frame: 0 weeks, 4 weeks

    Serum LDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention

  2. HDL Cholesterol

    Time frame: 0 weeks, 4 weeks

    Serum HDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention

Secondary outcomes

  1. Gut Microbiome Diversity

    Time frame: 0 weeks, 4 weeks

    Fecal gut microbiome communities will be sequenced using microbial DNA extracted from samples at 0 and 4 weeks for each cornmeal intervention. Amplified copies of the 16S rRNA gene will be evaluated for treatment differences in alpha (within-sample richness and evenness) and beta diversity (between-sample community structure). Relative and differential abundance of individual microbial taxa will also be measured.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • North American Millers Association - Corn Division

Registry information

Official study title

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

Acronym: CHS

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 30, 2019
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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