Corn and Heart Health Study

NCT03967990 | Completed

• 1 other identifier: STUDY00007518
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiome; Cholesterol, LDL; Cholesterol, HDL

Keywords

cholesterol; gut microbiome; gut microbiota; dietary fiber; whole grain

Outcome Measures

Primary Outcomes (2)

• LDL Cholesterol

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

  0 weeks, 4 weeks

• HDL Cholesterol

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

  0 weeks, 4 weeks

Secondary Outcomes (1)

• Gut Microbiome Diversity

  0 weeks, 4 weeks

Study Arms (6)

refined-50/50-whole

EXPERIMENTAL

48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) refined cornmeal flour, followed by (2) 50/50 mix of refined cornmeal flour plus corn bran, followed by (3) whole grain cornmeal flour

Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour

50/50-whole-refined

EXPERIMENTAL

48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) 50/50 mix of refined cornmeal flour plus corn bran, followed by (2) whole grain cornmeal flour, followed by (3) refined cornmeal flour

Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour

whole-refined-50/50

EXPERIMENTAL

48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) whole grain cornmeal flour, followed by (2) refined cornmeal flour, followed by (3) 50/50 mix of refined cornmeal flour plus corn bran

Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour

refined-whole-50/50

EXPERIMENTAL

48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) refined cornmeal flour, followed by (2) whole grain cornmeal flour, followed by (3) 50/50 mix of refined cornmeal flour plus corn bran

Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour

50/50-refined-whole

EXPERIMENTAL

48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) 50/50 mix of refined cornmeal flour plus corn bran, followed by (2) refined cornmeal flour, followed by (3) whole grain cornmeal flour

Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour

whole-50/50-refined

EXPERIMENTAL

48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) whole grain cornmeal flour, followed by (2) 50/50 mix of refined cornmeal flour plus corn bran, followed by (3) refined cornmeal flour

Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour

Interventions

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-whole; 50/50-whole-refined; refined-50/50-whole; refined-whole-50/50; whole-50/50-refined; whole-refined-50/50

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

50/50-refined-whole; 50/50-whole-refined; refined-50/50-whole; refined-whole-50/50; whole-50/50-refined; whole-refined-50/50

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

50/50-refined-whole; 50/50-whole-refined; refined-50/50-whole; refined-whole-50/50; whole-50/50-refined; whole-refined-50/50

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Participants in this study will not be eligible if they are participating in other research studies at the same time.

Sponsors & Collaborators

• Arizona State University: lead
• North American Millers Association - Corn Division: collaborator

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85007, United States

Location

Related Publications (1)

• Liedike B, Khatib M, Tabarsi B, Harris M, Wilson SL, Ortega-Santos CP, Mohr AE, Vega-Lopez S, Whisner CM. Evaluating the Effects of Corn Flour Product Consumption on Cardiometabolic Outcomes and the Gut Microbiota in Adults with Elevated Cholesterol: A Randomized Crossover. J Nutr. 2024 Aug;154(8):2437-2447. doi: 10.1016/j.tjnut.2024.06.003. Epub 2024 Jun 14.

  PMID: 38880174 DERIVED

Study Officials

• Corrie M Whisner, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: March 20, 2018
• Primary Completion: August 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)