Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| North American Millers Association - Corn Division | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut Microbiome Diversity | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Corrie M Whisner, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Biomedical Collaborative | Phoenix | Arizona | 85007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38880174 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
| 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 |
|
| 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 |
|
| 0 weeks, 4 weeks |